Prior Authorization Requirement for Select Drugs

srv_ppsgw_P — Tue, 01 Sep 2026 04:42:56 GMT

EffectiveDate: 10/1/2026

PolicyNumber: Rx.01.202

LOB: Commercial

PolicyOwner: VanHorn, Lynnsey

QuarterlyCycle: C2-2026

Description:

Target drugs in the Prior Authorization Requirement for Select Drugs (PARSD) policy have prerequisites on the formulary with similar efficacy and safety profiles. The policy is designed to apply prior authorization to target drugs that have prerequisites that are more cost effective.

Definition:

Target: the drug to which the prior authorization is applied
Prerequisite: the alternative drugs(s) that must be used prior to approving the target drug

Intent:

The intent of this policy is to communicate the medical necessity criteria for selected drugs with generic and/or therapeutic alternatives as provided under the member's prescription drug benefit.

Policy:

A medication with alternative or alternatives is medically necessary when ALL of the following are met:

FDA approved, or compendia supported indication; and
Request is not for an excluded benefit (i.e., cosmetic); and
Inadequate response or inability to tolerate the alternative(s)

Authorization duration: 1 year

Target	Prerequisite(s)	Category
Vasotec®, Zestril®, Altace®, Accupril®, Lotrel®, Epaned®	3 generic angiotensin-converting enzyme (ACE) inhibitors (e.g., lisinopril, enalapril)	ACE-Inhibitors
Absorica [LD] ®	2 of the following: Amnesteem®, Claravis®, Myorisan®, Zenatane®	Acne agents
Daytrana®, amphetamine ER 1.25mg/ml suspension [Adzenys® ER], amphetamine [Adzenys XR-ODT®], Dyanavel XR®, Mydayis®, Cotempla®, Evekeo ODT, Zenzedi®, Xelstrym™, Vyvanse®, methylphenidate (Relexxii®) tab ER osmotic release, Arynta®	2 generic ADHD stimulants (e.g., methylphenidate, amphetamines, etc.)	ADHD
Concerta®, Dexedrine® spansule, Ritalin, Ritalin LA®, Focalin XR®, Adderall®, Adderall XR®, Kapvay®, Intuniv®, Strattera®	generic equivalent of requested brand	ADHD
Azstarys®	One generic ADHD stimulants (e.g., methylphenidate, amphetamines, etc.)	ADHD
QuilliChew®, Quillivant®, Aptensio®, Jornay PM®, Metadate CD®	Generic methylphenidate	ADHD
Qelbree™, Onyda™ XR	ONE of the following: generic atomoxetine, generic guanfacine ER, generic clonidine ER	ADHD
Alrex®, Alocril®, Zerviate™, Bepreve®	Two of the following generics: azelastine, cromolyn sodium, epinastine), olopatadine	Allergic conjunctivitis
Aricept®, Adlarity®	Generic donepezil tablets	Alzheimer's Disease
Zunveyl®	Minimum 30-day supply of two of the following: generic galantamine, generic rivastigmine, generic donepezil	Alzheimer's Disease
Atacand [HCT]®, Avapro [Avalide]®, Cozaar [Hyzaar]®, Diovan [HCT] ®, Micardis [HCT]®, Exforge [HCT]®, Benicar [HCT]®, Azor®, Tribenzor®, Edarbi®, Edarbyclor®, Tekturna®	3 generic angiotensin receptor blockers or combinations (e.g., losartan, olmesartan, valsartan tablet, etc.)	Angiotensin II receptor antagonists
Mysoline®	Generic primidone	Anticonvulsants
Lamictal®	generic lamotrigine	Anticonvulsants
Keppra ®, Elepsia™ XR, levetiracetam [Spritam®]	generic levetiracetam	Anticonvulsants
Brivaracetam [Briviact®], Xcopri®	One of the following generics: lamotrigine IR, levetiracetam IR, levetiracetam ER, oxcarbazepine IR, topiramate IR OR continuation of therapy with the requested drug	Anticonvulsants
Lyrica®	Generic pregabalin	Anticonvulsants
Topamax® [sprinkle]	topiramate	Anticonvulsants
Trokendi XR®, topiramate ER [Qudexy XR®], topiramate [Eprontia™]	Generic topiramate	Anticonvulsants
Oxcarbazepine ER [Oxtellar XR®]	generic oxcarbazepine	Anticonvulsants
Eslicarbazepine [Aptiom®]	Three generic anticonvulsants OR continuation of therapy with Aptiom®	Anticonvulsants
Tegretol®, Tegretol XR®, Carbatrol®	generic carbamazepine	Anticonvulsants
Neurontin®, Gabarone®	Generic gabapentin	Anticonvulsants
Felbatol®	Generic felbamate	Anticonvulsants
Zonegran®, Zonisade® suspension	Generic zonisamide	Anticonvulsants
Trileptal®	Generic oxcarbazepine	Anticonvulsants
Motpoly XR	Three generic anticonvulsants OR continuation of therapy with Motpoly XR	Anticonvulsants
Perampanel	Fycompa®	Anticonvulsants
Wellbutrin SR®, Prozac®, Lexapro®, Zoloft®, Effexor XR®, bupropion ER 450mg [Forfivo® XL], Pristiq®, Celexa®, Citalopram capsule, Sertraline capsule, Paxil [CR]®, Venlafaxine besylate tab ER, Raldesy®, Bucapsol®, escitalopram capsule	3 generic antidepressants (e.g., citalopram tablet, venlafaxine, bupropion, sertraline tablet, etc.)	Antidepressants
Symbyax®	Generic equivalent of requested brand	Antidepressants
Fetzima®, Viibryd®, Auvelity™	3 generic antidepressants (e.g., citalopram tablet, venlafaxine, bupropion, sertraline tablet, etc.) OR continuous therapy with requested agent for a minimum of 2 weeks	Antidepressants
Trintellix®, Exxua™	2 generic antidepressants (e.g., citalopram tablet, venlafaxine, bupropion, sertraline tablet, etc.) OR continuous therapy with requested agent for a minimum of 2 weeks	Antidepressants
Cymbalta®, Drizalma®	Duloxetine	Antidepressants
Duetact®	Generic pioglitazone-glimepiride	Anti-diabetic
Actos®	Generic pioglitazone	Anti-diabetics
Glucotrol®, Amaryl®	3 generic sulfonylureas (e.g., glipizide, glyburide, glimepiride)	Anti-diabetics
Metformin tab 625mg, metformin tab 750mg	ONE of the following: metformin IR 500mg, 850mg, metformin 1000mg	Anti-diabetics
Riomet®	Metformin oral solution	Anti-diabetics
Xultophy	Soliqua	Anti-diabetics
Symlin®	Insulin within 180 days	Anti-diabetics
Non-preferred diabetic testing supplies (test strips and meters)	Contour®	Anti-diabetics
Nesina®, Oseni®, Kazano®, Onglyza®, Sitagliptin [Zituvio], Sitagliptin/Metformin [Zituvimet, Zituvimet XR], Brynovin™	Two of the following: Januvia® or Janumet® AND Tradjenta® or Jentadueto®	Anti-diabetics
Metformin tab ER Osmotic	Generic Glucophage XR (Metformin ER) tablets	Anti-diabetics
Qtern®, Steglatro™, Steglujan™, Segluromet™, Invokana®, Invokamet® [XR], bexagliflozin [Brenzavvy™], dapagliflozin, dapagliflozin/metformin ER	Minimum of 3-months trial with ONE of the following: Jardiance, Synjardy [XR], Glyxambi or Trijardy XR AND minimum of 3-months trial with ONE of the following: Farxiga or Xigduo XR	Anti-diabetics
Mytesi®	HIV therapy and ONE of the following: loperamide or diphenoxylate/ atropine	Antidiarrheal
Compro®	Generic prochlorperazine suppository	Anti-emetics
Sancuso®	One of the following: generic granisetron, generic ondansetron, aprepitant	Anti-emetics
Alphagan® P, Azopt®, Combigan®, Cosopt®, Cosopt® PF, Iopidine®, Istalol®, Timoptic® Ocudose	Minimum of 30-day trial with the generic equivalent of the requested brand	Anti-glaucoma agents
Betoptic®-S	Two generic ophthalmic beta blockers (e.g., timolol, betaxolol, levobunolol)	Anti-glaucoma agents
Allopurinol 200mg tablets	Generic allopurinol 100mg tablet	Anti-gout
Colchicine capsules [Mitigare®], Colcrys®, Gloperba®	Colchicine tablets	Anti-gout
Febuxostat	generic allopurinol	Anti-gout
Uloric®	Both allopurinol and generic febuxostat	Anti-gout
Clemastine fumarate syrup	Both of the following: 2 second-generation generic antihistamines (e.g., loratadine, desloratadine, etc..) and generic clemastine fumarate tablets	Antihistamine
Clarinex®, Clarinex-D®, Dexchlorpheniramine/Ryclora®	BOTH of the following generics (desloratadine, carbinoxamine/Ryvent®)	Antihistamines
Bystolic®	Generic nebivolol	Antihypertensives
Clonidine ER [Nexiclon™ XR]	Both of the following generics: clonidine tablets and clonidine patches	Antihypertensives
Bethkis®, Kitabis®, Tobi® Nebulizer solution	Generic tobramycin nebulizer solution	Anti-infective
Firvanq®	Generic vancomycin 25mg/ml or 50mg/ml oral solution	Anti-infective
Griseofulvin ultramicrosize tablet [Fulvicin P/G]	ONE of the following: generic griseofulvin 125mg tablet, 250mg tablet, 500mg tablet	Anti-infective
Nuvessa™, Cleocin® ovules, Cleocin® cream	ONE of the following: generic metronidazole gel or generic clindamycin cream	Anti-infective
Likmez™	Generic metronidazole	Anti-infective
Solosec®	Both of the following: (1) generic metronidazole vaginal gel or generic clindamycin vaginal gel AND (2) metronidazole tablets or tinidazole tablets	Anti-infective
Vandazole™	ONE of the following: generic metronidazole vaginal gel or generic clindamycin vaginal gel	Anti-infective
Noxafil	Generic posaconazole	Anti-infectives
Zyvox	generic linezolid	Anti-infectives
Brexafemme®, Diflucan®	Generic fluconazole	Anti-infectives
Metronidazole 125mg tablet	Metronidazole 250mg tablet	Anti-infectives
Crotan®, Pruradik®	Generic permethrin cream	Anti-infectives
Daraprim®	Generic pyrimethamine	Anti-infectives
Vemlidy®	Generic entecavir and generic tenofovir disoproxil OR continuation of therapy with the requested agent	Anti-infectives
Lithobid®	Generic lithium carbonate OR continuation of therapy with the requested agent	Antimanic agent
Arimidex®	Generic anastrozole	Antineoplastic
Eulexin®	Generic flutamide	Antineoplastic
Jylamvo®	Generic methotrexate tablets	Antineoplastics
Sensipar®	Generic cinacalcet	Antiparathyroid agent
Effient®, Plavix®	Generic equivalent of the requested brand	Antiplatelets
Abilify Mycite®, Fanapt®, Caplyta™, Secuado®, Lybalvi™, Opipza™, Cobenfy™	2 generic antipsychotic agents (e.g., aripiprazole, paliperidone, quetiapine, risperidone, etc.) OR continuation of therapy with requested medication	antipsychotics
Abilify®, Geodon®, Risperdal®, Saphris®, Seroquel® [XR], Invega®, Zyprexa® [Zydis]	2 generic antipsychotic agents (e.g., aripiprazole, paliperidone, quetiapine, risperidone, etc.)	antipsychotics
Latuda®	Generic lurasidone tablets	antipsychotics
Xerese® cream	Generic acyclovir cream	Antiviral
Valtrex®	generic valacyclovir	Antivirals
Valium®, Xanax®, Xanax® XR, Klonopin®, Loreev™ XR	3 generic benzodiazepines (e.g., lorazepam, diazepam, alprazolam, clonazepam, etc.)	Benzodiazepine
Inderal LA®, Tenormin®, Tenoretic®, Kapspargo™, Coreg [CR]®, InnoPran XL®, Inderal XL®	3 generic beta blockers (e.g., propranolol, atenolol, metoprolol, etc.)	Beta blockers
Questran®, Welchol™ tablet, Welchol™ packet, Colestid®	2 generic bile acid sequestrants (e.g., colestipol, cholestyramine, colesevelam)	Bile acid sequestrants
Binosto®, Actonel®, Boniva®	2 generic bone resorption inhibitors (e.g., risedronate, alendronate, ibandronate)	Bone resorption inhibitors
Evista®	Generic raloxifene	Bone resorption inhibitors
Moviprep®, Plenvu®	One of the following: Suprep or Clenpiq or Suflave	Bowel prep agents
Golytely®	PEG-3350 oral solution	Bowel prep agents
Uroxatral®, Cardura® [XL], Flomax®, Rapaflo®, terazosin [Tezruly®]	2 generic alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin, prazosin, terazosin)	BPH
Jalyn®, Avodart™	Generic equivalent of the requested brand	BPH
Entadfi™3	One of the following generics (alfuzosin, doxazosin, tamsulosin, terazosin, silodosin) AND ONE of the following: 5-alpha-reductase inhibitor (i.e., finasteride 5mg, dutasteride) OR Phosphodiesterase type 5 inhibitor (i.e., tadalafil 2.5mg, 5mg)	BPH
Caduet®	Generic amlodipine-atorvastatin	Calcium channel blocker and HMG CoA reductase inhibitor combination
Cardizem CD®, Levamlodipine, Conjupri®, Norvasc®, Cardizem LA®, Cardizem®, Verelan®	3 generic calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil, etc.)	Calcium channel blockers
Inpefa™	Minimum 3 months trial of Jardiance® and minimum 3 months trial of Farxiga®	Cardiovascular agents
Depen Titratab®, Cuprimine®, penicillamine tablet	Penicillamine capsule	Chelating agents
Cuvrior®, Clovique®, Syprine®	Trientine capsule	Chelating agents
Niaspan®	Generic niacin	Cholesterol lowering agents
Lovaza®	Omega-3-acid ethyl esters	Cholesterol lowering agents
Zetia®	generic ezetimibe	Cholesterol lowering agents
Icosapent ethyl	Vascepa	Cholesterol lowering agents
Drospirenone-ethinyl estradiol/Jasmiel/Lo-Zumandimine/Loryna/Nikki/ Vestura (generic Yaz)	Yaz	Contraceptive
Drospirenone-ethinyl estradiol/Ocella/Syeda/ Zumandimine (generic Yasmin)	Yasmin	Contraceptive
Uceris®, Entocort EC®	Generic oral budesonide	Corticosteroid
Prednisolone [Millipred®], Alkindi®	One generic oral corticosteroid {e.g., hydrocortisone, methylprednisolone)	Corticosteroid
Prednisone Delayed Release (Rayos®)	Three generic immediate-release oral corticosteroids (e.g., hydrocortisone, dexamethasone, prednisone, methylprednisolone, prednisolone, etc.)	Corticosteroid
Livtencity™1	Minimum 2 weeks duration or inability to tolerate One of the following: ganciclovir IV, oral valganciclovir, foscarnet IV, or cidofovir IV	Cytomegalovirus (CMV)
Valcyte®	Generic valganciclovir	Cytomegalovirus (CMV)
Eucrisa®, Opzelura®, Vtama® for atopic dermatitis, Zoryve cream 0.15%, Zoryve cream 0.05%	One of the following: one generic topical steroid (e.g., triamcinolone, clobetasol, halobetasol, etc.) or one generic topical calcineurin inhibitor	Dermatological agents
Pimecrolimus [Elidel®]	generic tacrolimus ointment	Dermatological agents
Protopic®	generic tacrolimus	Dermatological agents
Plaquenil®, Sovuna™	Generic hydroxychloroquine tablet	Disease-modifying Antirheumatic Agents
Pradaxa Pak	One of the following: Eliquis, Xarelto, generic dabigatran capsules	DOAC
Pradaxa® capsule	Generic dabigatran capsule OR continuation of therapy with the requested agent	DOAC
Varenicline (Tyrvaya™), Vevye®, Tryptyr®	Both of the following: minimum 12-weeks (3-months) trial of Restasis and minimum 12-weeks (3-months) trial of Xiidra	Dry eye disease
Generic cyclosporine emulsion	Restasis	Dry eye disease
Cequa®	One cyclosporine 0.05% product	Dry eye disease
Cialis®, Viagra®, vardenafil [Levitra®], avanafil [Stendra®], Vybrique®	One of the following: sildenafil or tadalafil AND no concurrent use of nitrate	Erectile dysfunction agent
Crinone 8%	Endometrin®	Fertility
Gonal-F®, Gonal-RFF®, Menopur®	Follistim AQ®	Fertility
Trilipix™	Generic fenofibrate	Fibric acid derivatives
Tonmya®	Generic cyclobenzaprine tablet AND one of the following: amitriptyline, duloxetine, gabapentin, pregabalin immediate release	Fibromyalgia
Ursodiol [Reltone™], Urso® [Forte]	Generic ursodiol capsule	Gallstone agents
Canasa®	Generic equivalent of requested brand	Gastrointestinal agent
Carafate®	Generic sucralfate tablet or suspension	Gastrointestinal agent
Colazal®	Generic balsalazide	Gastrointestinal agent
Lialda®	Generic mesalamine delayed release tablet	Gastrointestinal agent
Librax®	Generic equivalent of requested brand	Gastrointestinal agent
Asacol HD®, Delzicol®	Generic equivalent of requested brand	Gastrointestinal agent
Lotronex®	Generic alosetron	Gastrointestinal agent
Gimoti™5	Generic oral metoclopramide	Gastrointestinal agent
Pentasa 500mg capsule	Generic mesalamine ER 500mg capsule	Gastrointestinal agent
Rectiv®	Generic nitroglycerin ointment	Gastrointestinal agent
Syndros®	Generic dronabinol	Gastrointestinal agent
Glucagen®, Gvoke®2	ONE of the following: Glucagon® (Fresenius), Baqsimi®, Zegalogue®	Glucagon agents
Pepcid	Two of the generics: famotidine, nizatidine, cimetidine, ranitidine	H2- Antagonists
Lescol® XL, Lipitor®, Crestor®, pitavastatin [Livalo®], Vytorin® Zypitamag®, Ezallor®, Zocor®, ezetimibe/atorvastatin, Altoprev®	3 generic HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin, rosuvastatin, pravastatin, etc.)	HMG Co A reductase inhibitors
Minivelle®, Alora®, Climara®, Menostar®	Vivelle-Dot®	Hormone Replacement Therapy
Angeliq® tablet	One generic estrogen-progestin combination (e.g., estradiol-norethindrone acetate, Jinteli, Minvey)	Hormone Replacement Therapy
Femring®, Vagifem®, Estrace cream®	Generic estradiol vaginal cream or vaginal tablet	Hormone replacement therapy
Intrarosa®	Imvexxy™	Hormone replacement therapy
Depo-Estradiol®	Generic estradiol injection in oil formulation	Hormone replacement therapy
Inspra®, Carospir®	Both of the following: generic spironolactone, eplerenone	Hypertension
Vecamyl®	2 generic antihypertensives in different classes	Hypertension
Dicyclomine 40mg tablet	2 of the following: dicyclomine 10mg capsule, dicyclomine 10mg oral solution, or dicyclomine 20mg tablet	IBS
Viberzi®	One antidiarrheal medication (e.g., loperamide) AND one antispasmodic (e.g., dicyclomine, etc.)	IBS
Amitiza®	BOTH of the following: Lactulose solution or lubiprostone and Linzess® or Symproic®	IBS
Trulance ®, Zelnorm®, Ibsrela®	Both of the following: Linzess® and One of the following: lactulose solution or lubiprostone	IBS
Motegrity®	ALL of the following: Linzess®, generic lactulose solution, and generic prucalopride	IBS
Prograf®	Generic tacrolimus OR continuation of therapy with the requested agent	Immunosuppressants
Neoral®	Generic cyclosporine OR continuation of therapy with the requested agent	Immunosuppressants
Xepi™	mupirocin	Impetigo agents
Arava®	Generic leflunomide	Inflammatory conditions
Accrufer®	One of the following generics: ferrous sulfate, ferrous gluconate, ferrous fumarate	Iron preparations
lactulose packet [Kristalose® packet]	lactulose solution	Laxative
Singulair®	Generic montelukast	Leukotriene modifiers
Zileuton ER, Zyflo®	Both of the following generics: montelukast and zafirlukast	Leukotriene modifiers
Soaanz®	Two generic loop diuretics (e.g., torsemide, furosemide)	Loop diuretics
Rebif [Rebidose]®,Ponvory®, Tascenso ODT™, Plegridy®	2 of the following: Avonex®, Betaseron®, generic glatiramer, Vumerity®, Bafiertam®, dimethyl fumarate, Kesimpta®, Mayzent®, Zeposia® OR continuation of therapy with the requested agent	MS
Aubagio®	Generic teriflunomide	MS
Copaxone®	Generic glatiramer	MS
Gilenya® 0.5mg	Generic fingolimod	MS
Tecfidera®	Dimethyl fumarate AND one of the following: Vumerity® or Bafiertam®	MS
Cladribine pak [Mavenclad®]	One of the following: Avonex®, Betaseron®, generic glatiramer, Vumerity®, Bafiertam®, dimethyl fumarate, Kesimpta®, Mayzent®, Zeposia® OR continuation of therapy with the requested agent	MS
Conzip®, Tramadol solution [Qdolo®]	2 generic tramadol products	Narcotic analgesic
Butalbital/APAP 25/325mg tablet [Allzital®], Butalbital/APAP 50/300mg tabs/caps	Butalbital/APAP 50/325mg tabs	Non-Narcotic Analgesic
Zebutal®, Esgic®	Butalbital/APAP/Caffeine 50/325mg/40mg tabs OR caps	Non-Narcotic Analgesic
Anaprox DS®, Naprosyn®, EC-Naprosyn®, Cambia pack®, Celebrex®, Arthrotec®, Daypro®, Mobic®, Diclofenac capsule [Zipsor®], Fenoprofen, Fenortho™, Fenopron®, Nalfon®, Relafen [DS®], indomethacin [Tivorbex®, Indocin®], Meloxicam [Vivlodex®], Ketoprofen [Kiprofen] caps, Cataflam®, ketorolac tromethamine nasal spray [Sprix®], Elyxyb™, Naprelan®, oxaprozin [Coxanto™], Dolobid®, Combogesic®, Ibuprofen 300mg tab, Vyscoxa suspension, meloxicam capsule, Orudis®	3 generic prescription strength NSAIDS (e.g., ibuprofen (200mg, 400mg, 600mg, 800mg), naproxen, diclofenac, celecoxib, meloxicam caps/tabs, etc.)	NSAIDs
Bromsite®, Ilevro®, Nevanac®, Prolensa®	TWO of the following: generic Ketorolac op sol 0.5%, Flurbiprofen op sol 0.03%, diclofenac op sol 0.1%	Ophthalmic NSAIDs
Zioptan®, Vyzulta™, Xelpros®, Travatan Z®, Iyuzeh™, Omlonti®	ONE of the following generics: latanoprost, bimatoprost, travoprost AND Lumigan®	Ophthalmic prostaglandins
Pred Forte® ophthalmic suspension, clobetasol ophthalmic suspension	One generic ophthalmic steroid suspension (e.g., Prednisolone ophthalmic suspension, fluorometholone ophthalmic suspension, dexamethasone ophthalmic suspension)	Ophthalmic steroids
Seglentis®	3 generic alternatives indicated for acute pain (e.g., hydrocodone/acetaminophen, tramadol, acetaminophen, oxycodone/acetaminophen, etc.)	Opioid analgesic
Oxycodone [Roxybond®]	Two generic opioid analgesics or documentation of a history of or a potential for drug abuse for individual or a member of the individual's household	Opioid analgesics
Dilaudid®, MS Contin®, Roxicodone®, Oxaydo®, Xodol®, Methadose®, Ultracet®, Ultram®, Fioricet® with codeine, Fioricet®	Generic equivalent of requested brand	Opioid analgesics
Prolate®, Oxycodone/Acetaminophen 2.5-300mg, 5-300mg, 7.5-300mg, 10-300mg, Nalocet 2.5-300mg, Oxycodone/Acetaminophen solution 5/325mg	Generic oxycodone/acetaminophen tablet	Opioid analgesics
Oxycontin®, Oxycodone ER, Hysingla®	Xtampza® ER	Opioid analgesics
Relistor®	BOTH of the following: Symproic® and One of the following: lactulose solution or lubiprostone	Opioid induced constipation
Lofexidine [Lucemyra®]	Generic clonidine	Opioid withdrawal
Carbamazepine suspension, gabapentin solution, pregabalin solution, oxcarbazepine suspension, nortriptyline solution, fluoxetine solution, metformin solution, amlodipine (Katerzia, Norliqva), enalapril solution, lisinopril (Qbrelis) solution, valsartan solution, vancomycin solution, nitrofurantoin suspension, valganciclovir solution, indomethacin suspension, naproxen suspension, methotrexate (Xatmep) solution, pyridostigmine solution, Thyquidity solution, simvastatin (Flolipid) suspension, atorvastatin calcium (Atorvaliq) suspension, Xromi®, Inzirqo®, losartan (Arbli®), hydrocortisone (Khindivi®), Lopressor solution, cimetidine solution, desloratadine solution, Javadin, Subvenite suspension, Sdamlo®, meloxicam suspension [Zybic®]	Oral solid dosage formulation (tablet or capsule) of the drug requested OR one of the following: drug will be administered via nasogastric or gastronomy tube; or member is unable to swallow an intact capsule or tablet	Oral liquid dosage formulations that have a tablet or capsule formulation available6
Gelnique®, Oxytrol®, Ditropan XL®, Detrol®, Detrol LA®	2 generic alternatives (e.g., solifenacin, oxybutynin, tolterodine, etc.)	Overactive bladder agents
Toviaz®, Gemtesa®	Both of the following: Myrbetriq® AND 2 generic alternatives (e.g., solifenacin, oxybutynin tabs/tab ER/syrup, tolterodine, etc.)	Overactive bladder agents
Vesicare®, Vesicare LS®	Generic solifenacin	Overactive bladder agents
Pancreaze®, Pertzye®, Viokace®	Both of the following: Creon® and Zenpep®	Pancreatic enzymes
Mestinon®	Generic pyridostigmine	Parasympathomimetic
Dhivy	Carbidopa-levodopa IR and carbidopa-levodopa ODT	Parkinson's disease
Gocovri®	Generic amantadine	Parkinson's disease
Ongentys®, tolcapone [Tasmar®]	Generic entacapone	Parkinson's disease
Neupro®	Generic pramipexole and ropinirole	Parkinson's Disease, Restless leg syndrome
Xadago®	generic rasagiline and selegiline	Parkinson's disease
Carbidopa/levodopa [Rytary®], Crexont®	generic carbidopa/ levodopa	Parkinson's disease
Lanthanum [Fosrenol®]	Generic sevelamer	Phosphate removing agents
Phoslyra® solution	Generic calcium acetate	Phosphate binder agents
Xphozah®, Velphoro®	Minimum 30-day supply of two of the following: calcium carbonate, calcium acetate, lanthanum carbonate, sevelamer carbonate, sevelamer HCL, Auryxia	Phosphate removing agents
Durlaza®	aspirin	Platelet inhibitors
DDAVP	generic desmopressin acetate nasal spray	Posterior pituitary hormones
Sorilux® (calcipotriene foam 0.005%)	3 prescription strength, generic topical corticosteroids	Psoriasis agents
Zoryve™ cream 0.3%, Vtama® for psoriasis	ONE of the following: generic topical corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, or combination topical therapy	Psoriasis agents
Airsupra™	Both of the following: one inhaled corticosteroid (ICS) with albuterol AND minimum 30-day supply of brand Symbicort	Pulmonary
Pulmicort® suspension	Generic budesonide inhalation suspension	Pulmonary
Xopenex® nebulizer solution	Generic levalbuterol nebulizer solution	Pulmonary
Proventil® Ventolin®, Xopenex®	albuterol HFA	Pulmonary
Alvesco®, Asmanex®, beclomethasone [Qvar®], Flovent Diskus/ HFA®, Fluticasone HFA, Fluticasone AER, Fluticasone INH	Two of the following: Arnuity Ellipta® and Pulmicort Flexhaler®	Pulmonary
Dulera®, Fluticasone/Salmeterol HFA, Advair® Diskus, Fluticasone/vilanterol inhaler, Breyna AER	TWO of the following: Breo Ellipta®, Symbicort® or Advair® HFA	Pulmonary
Bevespi Aerosphere®, Duaklir®, umeclidinium bromide/vilanterol trifenatate	ONE of the following: Anoro Ellipta®, Stiolto Respimat®	Pulmonary
Tudorza®, Yupelri™, Incruse® Ellipta, tiotropium bromide cap	Spiriva®	Pulmonary
Budesonide-formoterol fumarate dihydrate aerosol	Six-month trial of brand Symbicort® within the previous 365 days	Pulmonary
Anusol®-HC, Hemmorex®-HC, Proctocort® suppositories, Anucort-HC	Generic hydrocortisone acetate suppositories	Rectal preparations
Pokonza™, potassium powder 40MEQ	Generic Potassium chloride (tablets, solution, capsules, packets, crystals, etc.)	Replacement preparations
Finacea®, Zilxi®, Epsolay®, ivermectin cream	Soolantra®	Rosacea
Rhofade®	Mirvaso®	Rosacea
Noritate®	Soolantra® or Mirvaso®	Rosacea
Evoxac®	Generic cevimeline	Sjogren's Syndrome agent
Metaxalone [Skelaxin®], Soma®, Zanaflex®, Cyclobenzaprine ER [Amrix ER®], Lorzone®, Orphenadrine w aspirin & Caffeine [Norgesic®, Norgesic Forte®, Orphengesic tab forte®], Ontralfy®, tizanidine 8mg capsule	2 generic skeletal muscle relaxants (e.g., carisoprodol, tizanidine 2mg, 4mg, 6mg, cyclobenzaprine, chlorzoxazone 500mg, etc.)	Skeletal muscle relaxants
Baclofen solution [Ozobax™], Baclofen solution [Ozobax™ DS], Baclofen suspension [Fleqsuvy™], Lyvispah™	Generic baclofen tablets	Skeletal muscle relaxants
Zoryve™ 0.3% foam for seborrheic dermatitis	ONE of the following: Corticosteroids (e.g., betamethasone, clobetasol); Antifungals (e.g., ciclopirox, ketoconazole); calcineurin inhibitors (e.g., tacrolimus)	Skin and mucous membrane agents
Zoryve 0.3% foam for plaque psoriasis	One of the following: Corticosteroids (e.g., betamethasone, clobetasol), Vitamin D analogs (e.g., calcitriol, calcipotriene), Tazarotene, Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), Combination topical therapy (e.g., vitamin D analog/corticosteroid)	Skin and mucous membrane agents
Rozerem™	Generic ramelteon	Sleep agents
Restoril®, Halcion®, Doral®	2 generic benzodiazepines indicated for sleep (e.g., temazepam, triazolam, quazepam, estazolam, etc.)	Sleep agents
Ambien® 5mg [CR 6.25mg], Lunesta® 1mg, 2mg, Zolpidem 7.5mg capsules	2 generic sleep aids (e.g., zolpidem tablets, zolpidem ER tablets, eszopiclone, zaleplon, etc.)	Sleep agents
Doxepin [Silenor®], Belsomra®	Two of the following: eszopiclone, zaleplon, zolpidem	Sleep agents
Quviviq™, Dayvigo®	Belsomra® AND Two of the following: eszopiclone, zaleplon, zolpidem	Sleep agents
Nuvigil®, Provigil®	generic modafinil or armodafinil	Sleep agents
Ortikos®	Generic budesonide cap 3mg DR (Entocort EC®)	Systemic glucocorticoid
Acticlate®, Avidoxy, Doryx DR®, Doryx MPC®, Minocin®, Minolira™ 4, Solodyn®4, doxycycline hyclate [Targadox®], Minocycline ER [Ximino®]4, Seysara™ 4; doxycycline hyclate 80mg ER, Lymepak, Monodoxyne XL, Monodxyne NL, doxycycline monohydrate 75mg and 150mg capsule and tablet	2 generic alternatives (e.g., doxycycline, minocycline, tetracycline)	Tetracyclines
Tetracycline tablet	Generic tetracycline capsule	Tetracyclines
Cytomel®	Generic liothyronine OR continuation of therapy with the requested agent	Thyroid agent
Levothyroxine [Tirosint®], Ermeza™	Generic levothyroxine	Thyroid replacement
Synthroid®	Generic levothyroxine OR continuation of therapy with the requested agent	Thyroid replacement
Actiq®, fentanyl citrate (Fentora®)	Generic oral transmucosal fentanyl citrate	TIRF
Tazorac®, tazarotene [Fabior®]	Tazarotene	Topical acne agents
Differin®, Retin-A®, Retin-A micro® 0.04%, 0.06%, 0.1%, Atralin®, Altreno™, Aklief®, Adapalene pad 0.1%, Arazlo®, Avita®	2 generic topical vitamin A derivative products	Topical acne agents
Generic tretinoin 0.08%	Retin-A Micro 0.08%	Topical acne agents
Amzeeq®, Cleocin T®, Evoclin foam®, Azelex® cream®, Clindagel®	2 generic, topical antibiotic or topical antibiotic combination products	Topical acne agents
Generic clindamycin-benzoyl peroxide 1.2-3.75%	Onexton™	Topical acne agents
Dapson (Aczone®) gel	3 of the following generics: adapalene cream/gel, adapalene/benzoyl peroxide, clindamycin gel/lotion/solution, clindamycin/tretinoin, erythromycin/benzoyl peroxide, tretinoin cream/gel	Topical acne agents
Acanya®, Benzamycin gel®, Benzamycinpak gel®, Clindamycin/benzoyl peroxide 1% / 5%, Veltin gel®, Ziana®, Twyneo®, Cabtreo™ gel	Epiduo® Forte	Topical acne agents
Winlevi®	One generic topical vitamin A derivative product AND one generic topical antibiotic/topical antibiotic combination product	Topical acne agents
Lidoderm® patches, Ztlido™, Tridacaine [II]	generic lidocaine patch	Topical anesthetics
Loprox®, Extina®, Oxistat®, econazole [Ecoza®], Xolegel®, luliconazole [Luzu®], mico-zn-petro [Vusion®], Ertaczo®, sulconazole [Exelderm®], oxiconazole	2 generic, prescription strength, topical antifungals (e.g., ketoconazole, ciclopirox, etc.)	Topical antifungal
Duobrii®	All of the following: (1) Generic tazarotene cream; and (2) one high potency topical corticosteroid (e.g., clobetasol, betamethasone, halobetasol, fluocinonide); and (3) one of the following: (a) Enstilar®; or (b) Wynzora®, or brand/generic Taclonex® (calcipotriene-betamethasone)	Topical steroid
Clobex®, Olux/ Olux E®, Ultravate®, Topicort®, Kenalog®, Luxiq®, clocortolone pivalate [Cloderm®], Desowen®, flurandrenolide [Cordran®, Nolix®], Derma-smoothe®, Synalar®, Locoid®, Locoid Lipocream®, Halog®, Verdeso®, Capex®, Pandel®, Sernivo®, Lexette®, Bryhali®; diflorasone diacetate, triamcinolone ointment 0.05% /Tritocin [Trianex®], Impeklo™, Pramosone®, hydrocortisone [Texacort™], clobetasol cream [Impoyz™], Ala Scalp®, halobetasol lotion 0.05%	3 prescription strength, generic topical steroids	Topical steroid
Anafranil™, Pamelor®	3 generic tricyclic antidepressants (e.g., nortriptyline, amitriptyline, imipramine, etc.)	Tricyclic antidepressants
Thiola EC	Generic tiopronin DR	Urinary Stone Agents
Rayaldee®	generic calcitriol	Vitamin D analog
Brand prenatal vitamins	3 generic prenatal vitamins (various)	Vitamins, prenatal

1. Livtencity™ is approved for 56 days/180 days

2. Gvoke® does not require prior authorization for members under 6 years of age.

3. Entadfi is approved for maximum 182 days/365 days (authorization duration is 182 days)

4. Solodyn®, Minolira™, Seysara™, Ximino® are approved for maximum of 84 days/180 days (authorization duration is 84 days)

5. Gimoti™ is approved for maximum of 56 days/180 days (authorization duration is 56 days)

6. Oral liquid dosage formulations that have a tablet or capsule formulation available, prior authorization does not apply for members under 13 years of age.

BlackBoxWarning:

Acetaminophen-containing agents
Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 miligrams per day, and often involve more than one acetaminophen-containing products.

Acne Agents
Absorica®, Absorica LD™

Pregnancy Category X: Causes birth defects: Absorica™, Absorica LD™ must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Absorica™, Absorica LD™ in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Absorica™, Absorica LD™ is available only through a restricted program called the iPLEDGE program. Prescribers, patients, pharmacies, and distributors must enroll in the program.

ADHD stimulants

Daytrana®, Concerta®, Ritalin LA®, Focalin®,

A. Drug dependence: should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. CNS stimulants, including Focalin and Ritalin LA, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Adzenys® ER, Adzenys XR-ODT™, Dyanavel® XR, Dexedrine®, Adderall® [XR], QuilliChew ER™, Quillivant XR®, Aptensio XR™, Cotempla®, Azstarys™, Vyvanse®

Abuse and dependence: CNS stimulants, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy
Particular attention should be paid to subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed sparingly.
Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

Arynta™

Arynta™ has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including ARYNTA, can result in overdose and death.

Before prescribing ARYNTA, assess each patient's risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.
Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction

Strattera®

Suicidal ideation in children and adolescents: increases the risk of suicidal ideation in short-term studies in children and adolescents with ADHD. Anyone considering the use in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Strattera® is approved for ADHD in pediatric and adult patients. Strattera® is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving Strattera® compared to placebo. The average risk of suicidal ideation in patients receiving Strattera® was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.

Qelbree®
In clinical studies, higher rates of suicidal thoughts and behavior were reported in pediatric patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

Zenzedi®
Amphetamines have a high potential for abuse. administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided. particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly. misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

Antihypertensives

Atacand HCT®, Avapro®, Cozaar®, Diovan HCT®, Micardis® HCT, Teveten® HCT, Exforge HCT®, Benicar HCT®, Azor®, Tribenzor®, Edarbi®, Edarbyclor®, Tekturna®
Fetal toxicity: when pregnancy is detected, discontinue as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Anti-infectives

Likmez™

Metronidazole has been shown to be carcinogenic in mice and rats (5.1). Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis (1.1), amebiasis (1.2) and anaerobic bacterial infections.

Antiplatelets

Effient®

Effient can cause significant, sometimes fatal, bleeding. Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke. In patients ≥75 years of age, Effient is generally not recommended, except in highrisk patients (diabetes or prior myocardial infarction [MI]), where its use may be considered. Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery. Additional risk factors for bleeding include: body weight <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding. Suspect bleeding in any patient who is hypotensive and has recently undergone invasive or surgical procedures. If possible, manage bleeding without discontinuing Effient. Stopping Effient increases the risk of subsequent cardiovascular events

Plavix®

Effectiveness of Plavix depends on conversion to an active metabolite by the cytochrome P450 (CYP) system, principally CYP2C19. Tests are available to identify patients who are CYP2C19 poor metabolizers. Consider use of another platelet P2Y inhibitor in patients identified as CYP2C19 poor metabolizers.

Angiotensin-converting enzyme (ACE) inhibitors
Vasotec®, Zestril®, Altace®, Accupril®, Lotrel®, Epaned®, Qbrelis®

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function. In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor drug during the ﬁrst trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone ﬁrst trimester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the ﬁndings of this study have not yet been repeated. When pregnancy is detected, discontinue ACEi as soon as possible

Anticonvulsants
Lamictal®

Serious skin rashes: rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking Lamictal® as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. Other than age, there are as yet no factors identified that are known to predict the risk of occurrence or the severity of rash caused by Lamictal®. There are suggestions, yet to be proven, that the risk of rash may also be increased by (1) coadministration of Lamictal® with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of Lamictal® or (3) exceeding the recommended dose escalation for Lamictal®. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by Lamictal® have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded by the first appearance of a rash. Although benign rashes are also caused by Lamictal®, it is not possible to predict reliably which rashes will prove to be serious or life threatening. Accordingly, Lamictal® should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug related. Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.

Sabril®

Sabril® can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, Sabril® also can damage the central retina and may decrease visual acuity. The onset of vision loss from Sabril® is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Symptoms of vision loss from Sabril® are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss. Vision assessment is recommended at baseline (no later than 4 weeks after starting Sabril®), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. Once detected, vision loss due to Sabril® is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. Risk of new or worsening vision loss continues as long as Sabril® is used. It is possible that vision loss can worsen despite discontinuation of Sabril®. Because of the risk of vision loss, Sabril® should be withdrawn from patients with refractory complex partial seizures who fail to show substantial clinical benefit within 3 months of initiation and within 2-4 weeks of initiation for patients with infantile spasms, or sooner if treatment failure becomes obvious. Patient response to and continued need for Sabril® should be periodically reassessed. Sabril® should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. Sabril® should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks. Use the lowest dosage and shortest exposure to Sabril® consistent with clinical objectives.

Tegretol®, Tegretol XR®, Carbatrol®

Serious and sometimes fatal dermatologic reactions, including Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported during treatment with Tegretol®, Tegretol XR®. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-b*1502, an inherited allelic variant of the HLA-b gene. HLA-b*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-b*1502 prior to initiating treatment with Tegretol®, Tegretol XR®. Patients testing positive for the allele should not be treated with Tegretol®, Tegretol XR® unless the benefit clearly outweighs the risk.

Aplastic anemia and agranulocytosis have been reported in association with the use of Tegretol®, Tegretol XR®. Data from a population-based case control study demonstrate that the risk of developing these reactions is 5-8 times greater than in the general population. However, the overall risk of these reactions in the untreated general population is low, approximately six patients per one million population per year for agranulocytosis and two patients per one million population per year for aplastic anemia. Although reports of transient or persistent decreased platelet or white blood cell counts are not uncommon in association with the use of Tegretol®, Tegretol XR®, data are not available to estimate accurately their incidence or outcome. However, the vast majority of the cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis. Because of the very low incidence of agranulocytosis and aplastic anemia, the vast majority of minor hematologic changes observed in monitoring of patients on Tegretol®, Tegretol XR® are unlikely to signal the occurrence of either abnormality. Nonetheless, complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Felbatol®
The use of Felbatol® (felbamate) is associated with a marked increase in the incidence of aplastic anemia. Accordingly, Felbatol® should only be used in patients whose epilepsy is so severe that the risk of aplastic anemia is deemed acceptable in light of the benefits conferred by its use. Ordinarily, a patient should not be placed on and/or continued on Felbatol® without consideration of appropriate expert hematologic consultation. Among Felbatol® treated patients, aplastic anemia (pancytopenia in the presence of a bone marrow largely depleted of hematopoietic precursors) occurs at an incidence that may be more than a 100-fold greater than that seen in the untreated population (i.e., 2 to 5 per million persons per year). The risk of death in patients with aplastic anemia generally varies as a function of its severity and etiology; current estimates of the overall case fatality rate are in the range of 20 to 30%, but rates as high as 70% have been reported in the past. There are too few Felbatol® associated cases, and too little known about them to provide a reliable estimate of the syndrome's incidence or its case fatality rate or to identify the factors, if any, that might conceivably be used to predict who is at greater or lesser risk. In managing patients on Felbatol®, it should be borne in mind that the clinical manifestation of aplastic anemia may not be seen until after a patient has been on Felbatol® for several months (e.g., onset of aplastic anemia among Felbatol® exposed patients for whom data are available has ranged from 5 to 30 weeks). However, the injury to bone marrow stem cells that is held to be ultimately responsible for the anemia may occur weeks to months earlier. Accordingly, patients who are discontinued from Felbatol® remain at risk for developing anemia for a variable, and unknown, period afterwards. It is not known whether or not the risk of developing aplastic anemia changes with duration of exposure. consequently, it is not safe to assume that a patient who has been on Felbatol® without signs of hematologic abnormality for long periods of time is without risk. It is not known whether or not the dose of Felbatol® affects the incidence of aplastic anemia.

Evaluation of postmarketing experience suggests that acute liver failure is associated with the use of Felbatol®. the reported rate in the U.S. has been about 6 cases of liver failure leading to death or transplant per 75,000 patient years of use. this rate is an underestimate because of under reporting, and the true rate could be considerably greater than this. For example, if the reporting rate is 10%, the true rate would be one case per 1,250 patient years of use. Of the cases reported, about 67% resulted in death or liver transplantation, usually within 5 weeks of the onset of signs and symptoms of liver failure. The earliest onset of severe hepatic dysfunction followed subsequently by liver failure was 3 weeks after initiation of Felbatol®. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice. It is not known whether or not the risk of developing hepatic failure changes with duration of exposure. It is not known whether or not the dosage of Felbatol® affects the incidence of hepatic failure. It is not known whether concomitant use of other antiepileptic drugs and/or other drugs affect the incidence of hepatic failure. Felbatol® should not be prescribed for anyone with a history of hepatic dysfunction. Treatment with Felbatol® should be initiated only in individuals without active liver disease and with normal baseline serum transaminases. It has not been proved that periodic serum transaminase testing will prevent serious injury but it is generally believed that early detection of drug induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery. There is no information available that documents how rapidly patients can progress from normal liver function to liver failure, but other drugs known to be hepatotoxins can cause liver failure rapidly (e.g., from normal enzymes to liver failure in 2-4 weeks). Accordingly, monitoring of serum transaminase levels (AST and ALT) is recommended at baseline and periodically thereafter. While the more frequent the monitoring the greater the chances of early detection, the precise schedule for monitoring is a matter of clinical judgement. Felbatol® should be discontinued if either serum AST or serum ALT levels become increased ≥ 2 times the upper limit of normal, or if clinical signs and symptoms suggest liver failure. Patients who develop evidence of hepatocellular injury while on Felbatol® and are withdrawn from the drug for any reason should be presumed to be at increased risk for liver injury if Felbatol® is reintroduced. Accordingly, such patients should not be considered for re-treatment.

Antidepressants

Prozac®, Lexapro®, Zoloft®, Effexor XR®, Fetzima™, Trintellix®, Pristiq®, Viibryd®, Cymbalta®, Pamelor™, Forfivo®, Exxua, Escitalopram capsule

Suicidality and antidepressant drugs: antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction on risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

Prozac® is not approved for use in children less than 7 years of age.

Lexapro® is not approved for use in pediatric patients less than 12 years of age.

Fetzima™, Pristiq®,Effexor XR, & Pamelor™ are not approved for use in pediatric patients.

Trintellix® & Viibryd® is not approved for use in pediatric patients.

Drizalma®

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors

Auvelity™

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. AUVELITY is not approved for use in pediatric patients.

Raldesy (trazodone) oral solution

WARNING: SUICIDAL THOUGHTS and BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. RALDESY is not approved for use in pediatric patients.

Anti-diabetics
Fortamet®, Kazano®, Jentadueto®, Xigduo® XR, Segluromet™, Invokamet® XR, Zituvimet XR, Riomet [ER] (metformin)

Lactic acidosis: postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. If metformin-associated lactic acidosis is suspected, immediately discontinue the drug and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Xultophy®

Liraglutide and semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Xultophy® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined
Xultophy® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with the use and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients.

Symlin®

Severe hypoglycemia: use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a Symlin® injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk.

Oseni®, Duetact®, Actos®

Congestive heart failure: thiazolidinediones, including pioglitazone, which is a component of pioglitazone, cause or exacerbate congestive heart failure in some patients. After initiation of pioglitazone and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of pioglitazone must be considered. It is not recommended in patients with symptomatic heart failure. Initiation of pioglitazone in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

Gimoti™

Tardive dyskinesia: Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage. Discontinue Gimoti in patients who develop signs or symptoms of TD. Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the risk of developing TD with longer-term use.

Anticoagulants
Pradaxa®
PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy

SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated

Antineoplastics

Jylamvo®

Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during and after treatment with Jylamvo.

Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis.

Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate.

Antipsychotics

Abilify®, Abilify Mycite®, Saphris®, Secuado®, Latuda, Opipza

Increased mortality in elderly patients with dementia-related psychosis: elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. They are not approved for the treatment of patients with dementia-related psychosis.
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
Latuda® is not approved for use in pediatric patients.
The safety and efficacy of Rexulti™, Abilify Mycite ®, Vraylar ®,Rexulti ®, & Secuado® have not been established in pediatric patients.
Abilify®, Abilify Mycite®, and Opipza increases risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor for worsening and emergence of suicidal thoughts and behaviors.

Fanapt®, Invega®, Caplyta™

Increased mortality in elderly patients with dementia-related psychosis: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of seventeen placebo-controlled trials (modal duration 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. They are not approved for the treatment of patients with Dementia-Related Psychosis.

Benzodiazepines
Ativan®, Valium®, Xanax®, Klonopin®, Loreev™, Librax®

Risks from concomitant use with opioids: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Bone resorption inhibitors

Evista®
Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA. Women with active or past history of venous thromboembolism should not take EVISTA. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke.

Chelating agents
Curprimine®

Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient should remain constantly under the close supervision of the physician. Patients should be warned to report promptly any symptoms suggesting toxicity.

Cytomegalovirus (CMV)

Valcyte®

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS See full prescribing information for complete boxed warning.

Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with VALCYTE.
Impairment of Fertility: Based on animal data and limited human data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
Fetal Toxicity: Based on animal data, VALCYTE has the potential to cause birth defects in humans.
Mutagenesis and Carcinogenesis: Based on animal data, VALCYTE has the potential to cause cancers in humans.

Dermatological agents
Elidel®, Protopic®

Long-term Safety of Topical Calcineurin Inhibitors has not been established. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors.Therefore, continuous long-term use of topical calcineurin inhibitors in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. These agents are not indicated for use in children less than 2 years of age. Only 0.03% Protopic® ointment is indicated for use in children 2-15 years of age

Opzelura®
SERIOUS INFECTIONS
Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death and adverse reactions.
Reported infections include:
Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
Invasive fungal infections, including candidiasis and pneumocystosis.
Bacterial, viral, and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.

The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA.

MORTALITY

Higher rate of all-cause mortality, including sudden cardiovascular death have been observed in patients treated with oral Janus kinase inhibitors for inflammatory conditions.

MALIGNANCIES

Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

Higher rate of MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.

THROMBOSIS

Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis has been observed at an increased incidence in patients treated with oral Janus kinase inhibitors for inflammatory conditions compared to placebo. Many of these adverse reactions were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

Estrogen Products

Estrace Cream®, Femring®, Vagifem®, Angeliq®, Depo-Estradiol

Warning: endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia

Estrogen-Alone Therapy
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Estrogen Plus Progestin Therapy
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
The WHI estrogen plus progestin substudy reported an increased risk of invasive breast cancer
The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

IBS
Trulance™
Risk of serious dehydration in pediatric patients: contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Avoid use in patients 6 years to less than 18 years of age. The safety and effectiveness of Trulance™ have not been established in patients less than 18 years of age.

Lotronex®
Infrequent but serious gastrointestinal adverse reactions have been reported with the use of Lotronex®. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery, and death. Lotronex® is indicated only for women with severe diarrhea predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. Discontinue Lotronex® immediately in patients who develop constipation or symptoms of ischemic colitis. Do not resume Lotronex® in patients who develop ischemic colitis.

Ibsrela®

Serious risk of dehydration in pediatric patients. Contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age.

MS agents
Aubagio®

Hepatotoxicity

Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with AUBAGIO in the postmarketing setting. Concomitant use of AUBAGIO with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO and monitor ALT levels at least monthly for six months. If drug induced liver injury is suspected, discontinue AUBAGIO and start accelerated elimination procedure.

Embryofetal Toxicity

Teratogenicity and embryolethality occurred in animals administered teriflunomide. Exclude pregnancy prior to initiating AUBAGIO therapy. Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure. Stop AUBAGIO and use an accelerated drug elimination procedure if the patient becomes pregnant.

Mavenclad®

Malignancies: Mavenclad® may increase the risk of malignancy. Mavenclad® is contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy. Follow standard cancer screening guidelines in patients treated with Mavenclad ®.
Risk of Teratogenicity: Mavenclad® is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the risk of fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with Mavenclad ® in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during Mavenclad ® dosing and for 6 months after the last dose in each treatment course. Stop Mavenclad ® if the patient becomes pregnant.

Narcotic analgesics
ConZip®, Ultram®, Ultracet®, Qdolo™

Addiction abuse and misuse: exposes patients and others to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions.
Life-threatening respiratory depression: serious, life-threatening, or fatal respiratory depression may occur with use. Monitor for respiratory for respiratory depression, especially during initiation or following a dose increase. Instruct patients to swallow ER tablets intact, and not to cut, break, chew, crush or dissolve the tablets to avoid exposure to potentially fatal dose.
Accidental ingestion: accidental exposure, especially by children, can result in fatal overdose.
Neonatal opioid withdrawal syndrome: prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatalogy experts. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that the appropriate treatment will be available.
Interactions with drugs affecting cytochrome P450 isoenzymes: the effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with tramadol are complex and requires careful consideration of the effects on the parent drug and the active metabolite.
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

NSAIDs
Anaprox ® DS, Coxanto, Naprelan®, Naprosyn®, EC-Naprosyn®, Celebrex®, Arthrotec®, Daypro®, Mobic®, Volatren® XR, Zipsor®, Tivorbex™, Vivlodex®, Cataflam®, Sprix®, Indocin®, Dolobid, Fenopron, ibuprofen 300mg, Orudis®, Zybic™

Cardiovascular risk: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. These agents are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer and/or GI bleeding
are at greater risk for serious gastrointestinal events.
For diclofenac and misorostol (Arthrotec®), the administration to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when misoprostol was administered to pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy. Diclofenac/misoprostol should not be taken by pregnant women.

Opioid Analgesics
1. Life-Threatening Respiratory depression: TIRFs (Actiq® , Fentora®, Subsys®), Lazanda®, Hydromorphone (Dilaudid), Hysingla™ ER, Morphine Sulfate: MS Contin®, Morphabond ER®, Oxycodone (Oxycontin®, Oxaydo®), Prolate™, Nalocet®, Seglentis®

Fatal respiratory depression has occurred in patients treated with the above listed opioid products, including following use in opioid-intolerant patients and improper dosing. Be sure to monitor for sign and symptoms of respiratory depression, especially during initiation of the drugs. The substitution of fentanyl sublingual/buccal for any other fentanyl product may result in fatal overdose. Because of the risk of respiratory depression, fentanyl products are contraindicated for use as an as-needed analgesic, or in the management of acute or postoperative pain, including headache/migraine and in opioid-intolerant patients. In addition, the concomitant use of fentanyl sublingual with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.

For hydromorphone and ER products like morphine ER, oxycodone ER, tapentadol ER, and oxymorphone ER products, instruct patients to swallow a whole tablet. Crushing, chewing, snorting, or dissolving tablets can cause rapid release and absorption that could lead to fatal overdose and even death. Note: Hydromorphone is a potent Schedule II controlled opioid agonist. Schedule II opioid agonists have the highest potential for abuse and risk of producing respiratory depression. Alcohol, other opioids, and CNS depressants (sedative-hypnotics) potentiate the respiratory depressant effects of hydromorphone, increasing the risk of respiratory depression that might result in death.

2. Medication errors: TIRFs (Actiq® , Fentora®, Subsys®), Lazanda®
Substantial differences exist in the pharmacokinetic profile of fentanyl sublingual/buccal compared with other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose. When prescribing, do not convert patients on a mcg-per-mcg basis from any other fentanyl products to fentanyl sublingual/buccal. When dispensing, do not substitute a fentanyl sublingual/buccal prescription for other fentanyl products.

3. Addiction and Abuse potential: TIRFs (Actiq® , Fentora®, Subsys®), Lazanda®, Hydromorphone (Dilaudid), Hysingla™ ER, Morphine Sulfate: MS Contin®, Morphabond ER®, Oxycodone (Oxycontin®, Oxaydo®), Prolate™, Nalocet®, Seglentis®

All opioid analgesics regardless of formulation are classified as Schedule II controlled substance, with high abuse liability. They expose patients and drug users to the risk of opioid addiction, abuse, and misuse, which can lead to overdose and death. Diversion, addiction, and abuse potential should be considered when prescribing or dispensing opioid analgesics. Providers must monitor all patients regularly for the development of these behaviors or conditions. Due to the risk for misuse, abuse, addiction, and overdose, some products such as fentanyl sublingual/buccal is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, outpatients, health care providers who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at http://www.TIRFREMSaccess.com or by calling 1-866-822-1483.

4. Cytochrome P450 3A4 interaction: TIRFs (Actiq® , Fentora®, Subsys®), Lazanda®, Oxycodone (Oxycontin®, Oxaydo®), Prolate™, Hysingla™, Nalocet®, Seglentis®

The concomitant use of fentanyl, oxycodone ER and hydrocodone ER with all cytochrome P450 3A4 (CYP3A4) inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving oxycodone ER and any CYP3A4 inhibitor or inducer.

5. Accidental exposure: Hydromorphone (Dilaudid), Morphine Sulfate: MS Contin®, Morphabond ER®, Oxycodone (Oxycontin®, Oxaydo®), Nalocet®, Seglentis®
Deaths due to a fatal overdose of the above listed opioid analgesics have occurred when children and adults were accidentally exposed to the drugs. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure. Accidental ingestion of even 1 dose, especially in children, can result in a fatal overdose and death.
6. Neonatal opioid withdrawal syndrome:
Prolonged use of opioid analgesics especially Hydromorphone (Dilaudid®), Hysingla™ ER, Morphine Sulfate: MS Contin®, Morphabond ER® , Oxycodone (Oxycontin®, Oxaydo®), Prolate™, Nalocet® , Seglentis® can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

7. Interaction with alcohol: Morphine Sulfate: MS Contin®, Oxycodone (Oxycontin®, Oxaydo®), Seglentis®

When using with alcohol, all opioid analgesic products have the potential to cause excessive sedation and may increase blood concentration of certain opioids like tapentadol, oxymorphone, and morphine. This could lead to fatal overdose and death. Instruct patients to avoid alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking opioid analgesics.
8. Information about oral morphine and oxycodone solution: Morphine Sulfate: MS Contin®, Oxycodone (Oxycontin®, Oxaydo®)

Morphine oral solution is available in 10 mg per 5 mL, 20 mg per 5 mL, and 100 mg per 5 mL (20 mg/mL) concentrations. The 100 mg per 5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care when prescribing and administering morphine oral solution to avoid dosing errors due to confusion between different concentrations and between milligrams and milliliters, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. Keep morphine oral solution out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.
Oxycodone concentrated oral solution is available as a 20 mg/mL concentration and is indicated for use in opioid-tolerant patients only. Take care when prescribing and administering oxycodone concentrated oral solution to avoid dosing errors due to confusion between milligram and milliliter, and other oxycodone solutions with different concentrations, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. Keep oxycodone out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

9. Risks from Concomitant Use with Benzodiazepines or other CNS Depressants: Hysingla™ ER, Prolate™, Nalocet®, Seglentis®
Concomitant use of opioid with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depressions, coma, and death. Addiction, abuse and misuse: life-threatening respiratory depression, accidental ingestion; neonatal opioid withdrawal; and risks from concomitant use with benzodiazepines or other CNS depressants.

Prolate™: Hepatoxicity, cytochrome P450 3A4 interaction

Sleep agents
Restoril™, Halcion®, Doral®,

Risk from concomitant use with opioids: Concomitant use of benzodiazepines and opioids: may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and duration to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Zolpidem tartrate (Ambien® and Ambien CR®), zolpidem (Intermezzo®, Zolpimist®), zolpidem tartrate sublingual tablets (Edluar®), eszopiclone 3mg (Lunesta®)

Complex sleep behaviors including sleepwalking, sleep driving, and engaging in other activities while not fully awake have been reported following use of zolpidem tartrate and eszopiclone. Some of these events have resulted in serious injuries, including death. Discontinue immediately if a patient experiences a complex sleep behavior.

Thyroid replacement agents
Thyquidity™: Thyroid hormones, including THYQUIDITY, should not be used for the treatment of obesity or for weight loss. Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity.

Ermeza®

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including ERMEZA, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

VALGANCICLOVIR Solution

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
See full prescribing information for complete boxed warning.

Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, and bone marrow failure including aplastic anemia have been reported in patients treated with valganciclovir hydrochloride.
Impairment of Fertility: Based on animal data and limited human data, valganciclovir hydrochloride may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.
Fetal Toxicity: Based on animal data, valganciclovir hydrochloride has the potential to cause birth defects in humans.
Mutagenesis and Carcinogenesis: Based on animal data, valganciclovir hydrochloride has the potential to cause cancers in humans.

Prochlorperazine (Compro) suppository

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Compro® Prochlorperazine Suppositories USP is not approved for the treatment of patients with dementia-related psychosis

Methotrexate (XATMEP) Solution

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY

Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate.

•: Bone marrow suppression
•: Serious infections
•: Renal toxicity and increased toxicity with renal impairment
•: Gastrointestinal toxicity
•: Hepatic toxicity
•: Pulmonary toxicity
•: Hypersensitivity and dermatologic reactions
•: Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP.

Neoral

Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Neoral, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients.

Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral Oral Solution (cyclosporine oral solution, USP) MODIFIED have increased bioavailability in comparison to Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune Oral Solution (cyclosporine oral solution, USP). Neoral and Sandimmune are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Neoral than with Sandimmune. If a patient who is receiving exceptionally high doses of Sandimmune is converted to Neoral, particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed.

Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral.

Cyclosporine, the active ingredient in Neoral, in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.

Prograf

ARNING: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death

Xromi

WARNING: MYELOSUPPRESSION AND MALIGNANCIES
Myelosuppression: XROMI may cause severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary.
Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies.

Cytomel

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including CYTOMEL, should not be used for the treatment of obesity or for weight loss.
Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity

Synthroid

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including SYNTHROID, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

References:

Abilify Mycite® (aripiprazole) [prescribing information]. Rockville, MD: Otsuka America Pharmaceuticals, Inc. December 2020. Available at: https://www.otsuka-us.com/media/static/ABILIFY-MYCITE-PI.pdf?_ga=2.72681619.1482915875.1558442487-890748463.1558442487. Accessed June 8, 2026.

Abilify® (aripiprazole) [prescribing information]. Rockville, MD: Otsuka America Pharmaceutical, Inc. July 2024. Available at: DailyMed - ABILIFY- aripiprazole tablet. Accessed June 8, 2026.

Absorica LD™ (isotretinoin) [prescribing information]. United Kingdom: M W Encap Ltd; October 2019. Available from: https://www.absoricald.com/pdfs/Absorica_Prescribing_Information.pdf. Accessed June 8, 2026.

Absorica® (isotretinoin) [package insert]. Jacksonville, FL: Ranbaxy Laboratories Inc.; October 2019. https://www.absorica.com/pdf/Absorica_Prescribing_Information.pdf Accessed June 8, 2026.

Acanya® (clindamycin phosphate and benzoyl peroxide) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; October 2016. Accessed June 8, 2026.

Accupril® (quinapril) [prescribing information]. New York, NY: Pfizer Inc.; November 2019. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=518. Accessed June 8, 2026.

Actiq® (fentanyl citrate) [prescribing information]. North Wales, PA: Teva Pharmaceutics Inc. October 2019. http://www.actiq.com/pdf/ActiqDigitalPIandMedGuide.pdf Accessed June 8, 2026.

Actonel® (risedronate) [prescribing information]. Irvine, CA: Allergan; November 2019. Accessed June 8, 2026.

Actos® (pioglitazone) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America, Inc; December 2016. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d2ddc491-88a9-4063-9150-443b4fa4330c. Accessed June 8, 2026.

Aczone® (dapsone) [prescribing information]. Parsippany, NJ: Allergan, Inc; September 2019. https://www.almirall.us/pdf/ACZONE-75-USPI-v1-20180518.pdf Accessed June 8, 2026.

Adderall® [XR] (mixed salts of a single-entity amphetamine product) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America, Inc. October 2023. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aff45863-ffe1-4d4f-8acf-c7081512a6c0. Accessed June 8, 2026.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder) [prescribing information]. Durham, NC: GlaxoSmithKline. June 2023. Available from: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Advair_Diskus/pdf/ADVAIR-DISKUS-PI-PIL-IFU.PDF. Accessed June 8, 2026.

Adzenys ER® (amphetamine) [prescribing information]. Grand Prairie, TX: Neos Therapeutics; December 2017. Accessed June 8, 2026.

Adzenys XR-ODT™ (amphetamine) [prescribing information]. Grand Prairie, TX: Neos Therapeutics; December 2017. http://www.neostxcontent.com/Labeling/Adzenys/Adzenys_PI.pdf Accessed June 8, 2026.

Airsupra™ (albuterol and budesonide) [prescribing information]. Wilmington, DE: AstraZeneca. January 2023. Available at: AIRSUPR Full Prescribing Information (den8dhaj6zs0e.cloudfront.net). Accessed June 8, 2026.

Aklief ® (trifarotene) [package insert] Fort Worth, Texas. Galderma Laboratories, L.P. October 2019. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=62d910db-85a6-4696-b69b-4bd2f3080cfc&type=display. Accessed on June 8, 2026.

Ala-scalp® (hydrocortisone) [prescribing information]. Petal, MS: Derm Ventures LLC; June 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=61498a40-3b3c-4066-89c8-d99686e2d638. Accessed June 8, 2026.

Alkindi (hydrocortisone) [prescribing information]. Eton Pharmaceuticals, Inc. September 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213876s000lbl.pdf. Accessed June 8, 2026.

Allopurinol [prescribing information]. February 2023. East Brunswick, NJ: Rising Pharma Holdings, Inc. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30ad5ba2-1cef-4933-b104-0597f6a2aaa2. Accessed June 8, 2026.

Alocril® (nedocromil sodium solution/drops) [prescribing information]. Madison, NJ: Allergan Inc; June 2018. Accessed June 8, 2026.

Alphagan® P (brimonidine tartrate ophthalmic solution) [prescribing information]. Irvine, CA: Allergan, Inc. September 2013. Available at: https://www.rxabbvie.com/pdf/alphagan_pi.pdf. Accessed June 8, 2026.

Alrex® (loteprednol) [prescribing information]. Bridgewater, NJ: Bausch & Lomb Inc; August 2019. Accessed June 8, 2026.

Altace® (ramipril) [prescribing information]. New York, NY: Pfizer Inc.; June 2017. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=716. Accessed June 8, 2026.

Altoprev® (lovastatin extended release) [prescribing information]. Ft. Lauderdale, FL: Watson Laboratories. December 2012. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf. Accessed June 8, 2026.

Altreno™ (tretinoin) [prescribing information]. Bridgewater, NJ. Valeant Pharmaceuticals North America LLC; March 2020. Available at: https://www.bauschhealth.com/Portals/25/Pdf/PI/altreno-pi.pdf. Accessed June 8, 2026.

Alvesco® (ciclesonide) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; October 2020. https://www.alvesco.us/_resources/100296-Alvesco-PI-Nov%202017.pdf. Accessed June 8, 2026.

Amaryl (glimepiride) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; December 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=222b630b-7e09-43b4-9894-3d87f10add91. Accessed June 8, 2026.

Ambien® (zolpidem tartrate) [prescribing information]. Paris, France: Sanofi-Aventis U.S. LLC; August 2019. http://products.sanofi.us/ambien/ambien.pdf. Accessed June 8, 2026.

Ambien® CR (zolpidem tartrate) prescribing information]. Paris, France: Sanofi-Aventis U.S. LLC; August 2019. http://products.sanofi.us/ambien/ambien.pdf. Accessed June 8, 2026.

Amitiza® (lubiprostone) [prescribing information]. Lake County, IL: Takeda Pharmaceuticals America, Inc.; November 2020. https://general.takedapharm.com/amitizapi. Accessed June 8, 2026.

Amrix® (cyclobenzaprine hydrochloride) [prescribing information]. Malvern, PA: Cephalon, Inc.; May 2020. http://www.amrix.com/Content/Pdf/prescribing-information.pdf. Accessed June 8, 2026.

Amzeeq™ (minocycline) [prescribing information]. Mohlin, Switzerland: ASM Aerosol-Service AG; January 2021. Available from: https://www.amzeeq.com/sites/default/files/documents/foamix-amzeeq-prescribing-information.pdf. Accessed June 8, 2026.

Anaprox® DS (naproxen) [prescribing information]. Phoenixville, PA: Genentech, Inc.; March 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf. Accessed June 8, 2026.

Angeliq® (drospirenone and estradiol) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals; November 2017. Accessed June 8, 2026.

Anucort-HC (hydrocortisone acetate suppository) [prescribing information]. South Plainsfield, NJ: Cosette Pharmaceuticals, Inc. November 2023. Available at: DailyMed - ANUCORT-HC- hydrocortisone acetate suppository. Accessed June 8, 2026.

Aptensio XR™ (methylphenidate) [prescribing information]. Coventry, RI: Rhodes Pharmaceuticals; June 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5adedc01-ebf0-11e3-ac10-0800200c9a66. Accessed June 8, 2026.

Aptiom® (eslicarbazepine acetate) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc. March 2019. Available from: https://www.aptiom.com/Aptiom-Prescribing-Information.pdf. Accessed June 8, 2026.

Arazlo™ (tazaotene) [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC; December 2019. Available from: https://www.bauschhealth.com/portals/25/pdf/pi/arazlo-pi.pdf. Accessed June 8, 2026.

Arbli® (losartan potassium suspension) [prescribing information]. Conmack, NY: Scienture LLC. March 2025. Available at: DailyMed - ARBLI- losartan potassium suspension. Accessed June 8, 2026.

Aricept (donepezil) [prescribing information]. New York, NY: Pfizer; December 2018. Accessed June 8, 2026.

Arthrotec® (diclofenac sodium and misoprostol) [prescribing information]. Skokie, IL: G.D. Searle LLC Division of Pfizer Inc; July 2020. http://labeling.pfizer.com/showlabeling.aspx?id=526. Accessed June 8, 2026.June 8, 2026.

ARYNTA (lisdexamfetamine dimesylate) [package insert]. Woburn, MA. Azurity Pharmaceuticals, Inc., June 2025. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219847s000lbl.pdf. Accessed June 8, 2026.

Asmanex Twisthaler® (mometasone furoate inhalation powder) [prescribing information]. Whitehouse, NJ: Merck & Co., Inc. December 2019. Available from: https://www.merck.com/product/usa/pi_circulars/a/asmanex/asmanex_pi.pdf. Accessed June 8, 2026.

Asmanex® HFA (mometasone furoate) [prescribing information]. Whitehouse, NJ: Merck & Co., Inc. August 2020. Available from: https://www.merck.com/product/usa/pi_circulars/a/asmanex_hfa/asmanex_hfa_pi.pdf. Accessed June 8, 2026.

Atacand HCT® (candesartan cilexetil and hydrochlorothiazide) [prescribing information]. Gaithersburg, MD: AstraZeneca Pharmaceuticals LP; February 2016. Accessed June 8, 2026.

Atorvaliq® (atorvastatin calcium) [prescribing information]. Farmville, NC: CMP Pharma Inc. February 2023. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=41fca2d8-7f3f-45b9-8974-81b89accc211. Accessed June 8, 2026.

Atralin® (tretinoin) [prescribing information]. Fort Worth, TX: Coria Laboratories; 2014. Accessed June 8, 2026.

Aubagio® (teriflunomide) [prescribing information]. Cambridge, MA: Genzyme Corporation. December 2022. Available at: https://products.sanofi.us/aubagio/aubagio.pdf. Accessed June 8, 2026.

Auvelity™ (dextromethorphan-bupropion) [prescribing information]. New York, NY: Axsome Therapeutics, Inc. December 2022. Available at: https://www.axsome.com/auvelity-prescribing-information.pdf. Accessed June 8, 2026.

Avalide® (irbesartan and hydrochlorothiazide) [prescribing information]. Paris, France: Sanofi-Aventis U.S. LLC; July 2018. Accessed June 8, 2026.

Avapro® (irbesartan) [prescribing information]. Paris, France: Sanofi-Aventis U.S. LLC; August 2019. http://products.sanofi.us/Avapro/Avapro.pdf Accessed June 8, 2026.

Avita® (tretinoin) [prescribing information]. Morgantown WV: Mylan Pharmaceuticals. July 2018. Accessed June 8, 2026.

Avodart® (dutasteride) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; January 2020. Accessed June 8, 2026.

Azelex® (azelaic acid) [prescribing information]. Parsippany, NJ: Allergan, Inc; 2017. Accessed June 8, 2026.

Azopt® (brinzolamide ophthalmic suspension) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. June 2023. Available at: https://www.novartis.com/us-en/sites/novartis_us/files/azopt.pdf. Accessed June 8, 2026.

Azor® (amlodipine besylate and olmesartan medoxomil) [prescribing information]. Parsippany, NJ: Daiichi Sankyo, Inc.; October 2020. https://dsi.com/prescribing-information-portlet/getPIContent?productName=Azor&inline=true Accessed June 8, 2026.

Beclomethasone dipropionate HFA inhalation aerosol [prescribing information]. Bridgewater, NJ. Amneal Pharmaceuticals NY LLC; July 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d853c96f-21a3-4def-931d-4d47d16acd62 Accessed June 8, 2026.

Belsomra® (suvorexant) [prescribing information]. Kenilworth, NJ: Merck Sharp & Dohme Corp; February 2021. https://www.merck.com/product/usa/pi_circulars/b/belsomra/belsomra_pi.pdf Accessed June 8, 2026.

Benicar HCT® (olmesartan medoxomil-hydrochlorothiazide) [prescribing information]. Parsippany, NJ: Daiichi Sankyo, Inc.; May 2020 . https://dsi.com/prescribing-information-portlet/getDocument?product=BNHCT&inline=true Accessed June 8, 2026.

Benzamycin® (erythromycin and benzoyl peroxide) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2016. Accessed June 8, 2026.

Bepotastine besilate ophthalmic solution 1.5% [prescribing information]. Somerset, NJ. Somerset Therapeutics, LLC; October 2024. Available from: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cd6a061d-8ad7-4ad1-b039-1e3aa3435d32. Accessed June 8, 2026.

Bepreve® (triamcinolone) [prescribing information]. Rochester, NY: Bausch & Lomb Incorporated; September 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68bbf6a0-c4b5-47c1-8a1c-08220fbdbce6. Accessed June 8, 2026.

Bethkis® (tobramycin) [prescribing information]. Cary, NC: Chiesi USA, Inc.; May 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1cd3d47b-025f-4705-9daf-cf07725ec223. Accessed June 8, 2026.

Betoptic S® (betaxolol hydrochloride ophthalmic suspension) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=71659a34-efad-4147-81c7-da10985e9224. Accessed on June 8, 2026.

Bevespi Aerosphere™ (glycopyrrolate and formoterol fumarate) [prescribing information]. Gaithersburg, MD: AstraZeneca Pharmaceuticals LP; November 2020. https://www.azpicentral.com/bevespi/bevespi.pdf#page=1 Accessed June 8, 2026.

Binosto® (alendronate sodium) [prescribing information]. Morristown, NJ: Ascend Therapeutics; December 2021. Available from: https://www.binosto.com/sites/all/themes/danlandBinosto/files/Prescribing_Information.pdf. Accessed June 8, 2026.

Boniva® (ibandronate) [prescribing information]. South San Francisco, CA: Genentech USA, Inc; October 2020. Accessed June 8, 2026.

Brenzavvy™ (bexagliflozin) [prescribing information]. Marlborough, MA: TheracosBio, LLC. September 2023. Available at: https://brenzavvy.com/wp-content/uploads/2023/10/Brenzavvy-Prescribing-Information-PI-001-09_FINAL.pdf. Accessed June 8, 2026.

Brexafemme® (ibrexafungerp tablets) [prescribing information]. Jersey City, NJ: Scynexis, Inc; June 2021. https://d1io3yog0oux5.cloudfront.net/scynexis/files/pages/scynexis/db/pis/Digital+Ibrexafungerp+Prescribing+Information+%28PI%29.pdf. Accessed June 8, 2026.

Breyna™ (budesonide and formoterol fumarate dihyrate) [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc. September 2020. Available at: These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA. BREYNA™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006 (nih.gov). Accessed June 8, 2026.

Brivaracetam tablets [prescribing information]. Pennington, NJ. Zydus Pharmaceuticals USA Inc.; September 2025. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d54ca946-2ddf-4a67-87c9-20a814bfd2dc&type=display. Accessed June 8, 2026.

Briviact® (brivaracetam) [prescribing information]. Smyrna, GA: UCB Inc.; May 2018. https://www.briviact.com/briviact-PI.pdf Accessed June 8, 2026.

Bromsite® (bromfenac ophthalmic solution) [prescribing information]. Cranbury, NJ: Sun Pharmaceuticals Industries, Inc. April 2016. Available at: https://www.bromsite.com/pdf/BromSitePI.pdf. Accessed June 8, 2026.

Bryhali® (halobetasol propionate) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC. June 2020. Available at: https://www.bauschhealth.com/Portals/25/Pdf/PI/Bryhali-PI.pdf. Accessed June 8, 2026.

Bucapsol (buspirone) [prescribing information]. Birelle, NJ: Pangea Pharmaceuticals. June 2025. Available at: DailyMed - BUCAPSOL- buspirone hydrochloride capsule. Accessed June 8, 2026.

Bystolic (nebivolol) [prescribing information]. North Chicago, IL: Abbvie Inc. August 2024. Available at: DailyMed - BYSTOLIC- nebivolol hydrochloride tablet. Accessed June 8, 2026.

Cabtreo™ (clindamycin phosphate, adapalene, and benzoyl peroxide) [prescribing information]. Bridgewater, NJ: Bausch Health US. LLC. October 2023. Available at: https://pi.bauschhealth.com/globalassets/BHC/PI/Cabtreo-PI.pdf. Accessed June 8, 2026.

Caduet® (amlodipine besylate and atorvastatin calcium) [prescribing information]. New York, NY: Pfizer Labs; January 2021. Accessed June 8, 2026.

Canasa® (mesalamine) rectal suppository [prescribing information]. Madison, NJ: Allergan USA Inc; November 2021. Accessed June 8, 2026.

Capex® (fluocinolone) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P.; 2015. Accessed June 8, 2026.

Caplyta™ (lumateperone) [prescribing information]. New York, NY: Intra-Cellular Therapies, Inc. December 2019. Available from: https://www.intracellulartherapies.com/docs/caplyta_pi.pdf. Accessed June 8, 2026.

Carafate® (sucralfate) [prescribing information]. Madison, NJ: Allergan USA, Inc; June 2018. Accessed June 8, 2026.

Carbatrol® (carbamazepine) [prescribing information]. Wayne, PA: Shire US Inc. March 2013. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf. Accessed June 8, 2026.

Cardizem LA® (diltiazem hydrochloride) [prescribing information]. Bridgewater, NJ: Bausch Health US LLC; September 2019. Accessed June 8, 2026.

Cardura (doxazosin) [prescribing information]. New York, NY: Pfizer; June 2021. Accessed June 8, 2026.

Carospir® (spironolactone) [prescribing information]. Farmville, NC: CMP Pharma, Inc; July 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c4f70a04-7d89-4b73-8b02-17d43471bf08. Accessed June 8, 2026.

Cataflam® (diclofenac potassium immediate-release tablets) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2016. Available from: https://www.novartis.us/sites/www.novartis.us/files/Cataflam.pdf. Accessed June 8, 2026.

Celebrex® (celecoxib) [prescribing information]. Skokie, IL: G.D. Searle LLC Division of Pfizer Inc; May 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=793 Accessed June 8, 2026.

Cequa™ (cyclosporin ophthalmic solution) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc. September 2019. Available at: https://cequapro.com/pdf/CequaPI.pdf. Accessed June 8, 2026.

Cialis (tadalafil) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; Feb 2018. Available from: https://pi.lilly.com/us/cialis-pi.pdf. Accessed June 8, 2026.

Clarinex® (desloratadine) [prescribing information]. Jersey City, NJ: Organon LLC; June 2021. Accessed June 8, 2026.

Cleocin® (clindamycin) [prescribing information]. North Peapack, NJ: Pharmacia and Upjohn Company LLC; August 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=df9a2a41-b132-4f43-8940-b2d773b1369a. Accessed June 8, 2026.

Climara® (estradiol once-weekly patch) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceutics Inc. December 2023. Available at: DailyMed - CLIMARA- estradiol patch. Accessed June 8, 2026.

Clindagel® (clindamycin) [prescribing information]. Cumberland, RI: Onset Dermatologics LLC; November 2017. https://www.bauschhealth.com/Portals/25/Pdf/PI/Clindagel-PI.pdf Accessed June 8, 2026.

Clindamycin Phosphate and Benzoyl Peroxide Gel 1%/5% [prescribing information]. Sugar Land, TX. 2017. Accessed June 8, 2026.

Clobetasol propionate ophthalmic suspension [prescribing information]. April 2024. Available at: DailyMed - CLOBETASOL PROPIONATE suspension/ drops. Accessed June 8, 2026.

Clobex® (clobetasol propionate) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P.; 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf Accessed June 8, 2026.

Cloderm® (clocortolone pivalate) [prescribing information]. Bridgewater, NJ: Promius Pharma, LLC; June 2017. http://www.clodermcream.com/wp-content/uploads/2018/09/ClodermCreamPI.pdf Accessed June 8, 2026.

Cobenfy. [Package insert]. Princeton, NJ: Karuna Therapeutics, Inc., Bristol-Myers Squibb; September 2024. Available at: COBENFY U.S. Prescribing Information. Accessed June 8, 2026.

Colcrys® (colchicine) [prescribing information]. Philadelphia, PA. AR Scientific Inc.; May 2020. https://general.takedapharm.com/COLCRYSPI Accessed June 8, 2026.

Colestid® (colestipol hydrochloride) [prescribing information]. New York, NY: Pfizer; April 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21b37725-fc0c-4365-a7dc-1a473d42502d. Accessed June 8, 2026.

Combigan® (brimonidine tartrate/timolol maleate ophthalmic solution) [prescribing information]. Irvine, CA: Allergan. October 2015. Available at: https://www.rxabbvie.com/pdf/combigan_pi.pdf. Accessed June 8, 2026.

Combogesic (acetaminophen and ibuprofen) [prescribing information]. Greenville, NC: Catalent Greenville, Inc. January 2025. Available at: DailyMed - COMBOGESIC- acetaminophen and ibuprofen tablet, film coated. Accessed June 8, 2026.

Compro (prochlorperazine) [prescribing information]. Minneapolis, MN: Padagis. November 2024. Available at: DailyMed - COMPRO- prochlorperazine suppository. Accessed June 8, 2026.

Concerta® (methylphenidate) [prescribing information]. Horsham, PA: Janssen Pharmaceuticals, Inc; January 2017. http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CONCERTA-pi.pdf Accessed June 8, 2026.

Conjupri™ (levamlodipine) [prescribing information]. Hot Springs, AR: Burke Therapeutics, LLC; August 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d1c7a0f2-9b6c-44a2-9e8c-70c3ce8a2aa8. Accessed June 8, 2026.

Conzip® (tramadol hydrochloride) [prescribing information]. Bridgewater, NJ: Vertical Pharmaceuticals, LLC; August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022370s015lbl.pdf Accessed June 8, 2026.

Copaxone (glatiramer acetate injection) [prescribing information]. Parsippany, NJ: Teva Neuroscience, Inc. February 2023. Available from: https://www.copaxone.com/globalassets/copaxone/prescribing-information.pdf. Accessed June 8, 2026.

Cordran® (flurandrenolide) [prescribing information]. Madison, NJ: Allergan USA, Inc.; May 2018. https://www.allergan.com/assets/pdf/cordran_pi Accessed June 8, 2026.

Coreg CR® (carvedilol phosphate) [prescribing information]. Research Triangle Park, NJ: GlaxoSmithKline; November 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=06400a4c-42b4-440a-92b4-1f47f98ac7ba. Accessed June 8, 2026.

Cosopt [PF] (dorzolamide hydrochloride and timolol maleate) [prescribing information]. Lexington, MA: Thea Pharma Inc. September 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=23bdf1c1-3134-4ad1-8e7c-bc655156bdc6. Accessed June 8, 2026.

Cotempla® (methylphenidate extended-release orally disintegrating tablets) [package insert]. Grand Prairie, TX: Neos Therapeutics Brands, LLC; June 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf. Accessed June 8, 2026.

Coxanto (oxaprozin) [prescribing information]. Madisonville, LA: Solubiomix. October 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217927s000lbl.pdf. Accessed June 8, 2026.

Cozaar® (losartan) [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; November 2019. https://www.merck.com/product/usa/pi_circulars/c/cozaar/cozaar_pi.pdf Accessed June 8, 2026.

Crestor® (rosuvastatin) [prescribing information]. Gaithersburg, MD: AstraZeneca Pharmaceuticals LP; September 2020. https://www.azpicentral.com/crestor/crestor.pdf#page=1 Accessed June 8, 2026.

Crexont (carbidopa and levodopa) [prescribing information]. Bridgewater, NJ: Amneal Specialty. August 2024. Available at: Amneal.com/pi/crexont.pdf. Accessed June 8, 2026.

Crinone® 8% (progesterone gel) [prescribing information]. Irvine, CA: Allergan USA, Inc. June 2017. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=75e97aa1-daa4-45f9-b2e2-1a371302914e. Accessed June 8, 2026.

Crotan (crotamiton) [prescribing information]. Charleston, SC: Marnel Pharmaceuticals LLC. April 2024. Available at: DailyMed - CROTAN- crotamiton lotion. Accessed June 8, 2026.

Cuprimine® (penicillamine) [prescribing information]. Lawrenceville, NJ: Aton Pharma, Inc.; November 2019. https://www.bauschhealth.com/Portals/25/Pdf/PI/Cuprimine-PI.pdf Accessed June 8, 2026.

Cuvrior™ (trientine tetrahydrochloride) [prescribing information]. Chicago, IL: Orphalan. April 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f73feeae-62ad-401e-b9f7-5cb269127750. Accessed June 8, 2026.

Cymbalta® (duloxetine) [prescribing information]. Indianapolis, IN: Lilly USA, LLC. May 2020. Available at: http://pi.lilly.com/us/cymbalta-pi.pdf. Accessed June 8, 2026.

Cytomel (liothyronine) [prescribing information]. New York, NY: Pfizer Inc. April 2025. Available at: DailyMed - CYTOMEL- liothyronine sodium tablet. Accessed June 8, 2026.

Daraprim (pyrimethamine) [prescribing information]. New York, NY: Vyera Pharmaceuticals LLC. November 2021. Available at: DailyMed - DARAPRIM- pyrimethamine tablet. Accessed June 8, 2026.

Daypro® (oxaprozin) [prescribing information]. Skokie, IL: G.D. Searle LLC Division of Pfizer Inc; May 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018841s030lbl.pdf. Accessed June 8, 2026.

Daytrana® patch (methylphenidate) [prescribing information]. New York, NY: Noven Therapeutics, LLC; October 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021514s030lbl.pdf. Accessed June 8, 2026.

Dayvigo™ (lemborexant) [prescribing information]. Woodcliff Lake, NJ: Eisai Inc.; April 2020. Available from: https://www.dayvigohcp.com/-/media/Files/DAYVIGOHCP/PDF/prescribing-information.pdf. Accessed June 8, 2026.

Acticlate® (doxycycline hyclate) [prescribing information]. West Chester, PA: Aqua Pharmaceuticals; October 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208253s000lbl.pdf Accessed June 8, 2026.

Depo-Estradiol (estradiol cypionate injection) [prescribing information]. New York, NY: Pfizer. June 2019. Available at: labeling.pfizer.com/ShowLabeling.aspx?id=595. Accessed June 8, 2026.

Derma-Smoothe® (flucinolone acetonide) [prescribing information]. Manasquan, NJ: Royal Pharmaceuticals; 2013. Accessed June 8, 2026.

Desowen® (desonide) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P.; 2015. Accessed June 8, 2026.June 8, 2026.

Dexedrine® (dextroamphetamine) [prescribing information]. Horsham, PA: Amedra Pharmaceuticals LLC; 2017. June 8, 2026.

Dhivy (carbidopa and levodopa) [prescribing information]. Alpharetta, GA: Avion Pharmaceuticals, LLC. September 2021. Available from: https://dhivyhcp.com/assets/pdf/dhivy-full-prescribing-information.pdf. Accessed June 8, 2026.

Differin® (adapalene) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P.; 2015. Accessed June 8, 2026.

Dificid® (fidaxomicin) [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; April 2020. Available from: https://www.merck.com/product/usa/pi_circulars/d/dificid/dificid_pi.pdf. Accessed June 8, 2026.

Diflucan® (fluconazole) [prescribing information]. New York, NY: Pfizer; March 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f694c617-3383-416c-91b6-b94fda371204. Accessed June 8, 2026.

Diovan HCT® (valsartan and hydrochlorothiazide) [prescribing information].. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2020. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/diovan_hct.pdf Accessed June 8, 2026.

Ditropan XL® (oxybutynin chloride) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; March 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=36cc9115-bef3-48fa-93ff-bcda24cf26e2. Accessed June 8, 2026.

Dolobid (diflunisal) [prescribing information]. Fairmont, WV: INA Pharmaceutics Inc. August 2024. Available at: DailyMed - DOLOBID- diflunisal tablet, film coated. Accessed June 8, 2026.

Doral® (quazepam) [prescribing information]. Norcross, GA: Galt Pharmaceuticals LLC; October 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018708s023lbl.pdf Accessed June 8, 2026.

Doryx® (doxycycline hyclate) [prescribing information]. Parsippany, NJ: Warner Chilcott (US), LLC; July 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99cf2de6-e0a3-42f2-9929-d33e107af948 Accessed June 8, 2026.

Doxycycline [prescribing information]. Pennington, NJ: Zydus Pharmaceuticals (USA) Inc. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9b52e0a7-f024-4d8a-a59e-374946e60b44. Accessed June 8, 2026.

Drizalma™ (duloxetine) [package insert] Mohali, India. Sun Pharmaceuticals. June 2020. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=b41423b8-dfec-4d79-ba3c-e43a87803d85&type=display. Accessed June 8, 2026.

Duaklir® (aclidinium bromide and formoterol fumarte) [package insert] Morrisville, North Carolina. Circassia, Pharmaceuticals Inc. February 2020. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=bb24d6b0-0d69-4a3c-a7f4-a35ca4804657&type=display. Accessed June 8, 2026.

Duetact® (pioglitazone and glimepiride) [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; January 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8b0c917-3fdd-4a28-a47d-6225b8195458. Accessed June 8, 2026.

Durlaza™ (acetylsalicylic acid) [prescribing information]. New Haven, CT: New Haven Pharmaceuticals, Inc.; September 2015. Accessed June 8, 2026.

Dyanavel® XR (amphetamine) [prescribing information]. Monmouth Junction, NJ: Tris Pharma Inc; February 2019. http://dyanavelxr.com/pdfs/pi.pdf Accessed June 8, 2026.

EC-Naprosyn® (naproxen) [prescribing information]. Phoenixville, PA: Genentech, Inc.; 2016. Accessed June 8, 2026.

Ecoza™ (econazole nitrate) [prescribing information]. Florham Park, NJ: Exeltis USA Dermatology, llc; 2016. Accessed June 8, 2026.

Edarbi® (azilsartan kamedoxomil) [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals, Inc.; March 2020. https://www.edarbi.com/media/pdf/EDARBI-PI.pdf Accessed December 10, 2025

Edarbyclor® (azilsartan kamedoxomil and chlorthalidone) [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals, Inc.; March 2020. https://www.edarbi.com/media/pdf/EDARBYCLOR-PI.pdf Accessed June 8, 2026.

Effexor XR® (venlafaxine hydrochloride) [prescribing information]. Collegeville, PA: Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.; December 2018. http://labeling.pfizer.com/showlabeling.aspx?ID=100 Accessed June 8, 2026.

Effient® (prasugrel) [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc; December 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6d790690-dc3f-4ab4-83e9-0ebff6c18d61. Accessed June 8, 2026.

Elepsia XR® (levetiracetam) [prescribing information]. Mumbai, IN: Sun Pharma Advanced Research Company Limited; January 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=12e147dc-4f5b-4117-8a8e-a8c429ad0217. Accessed June 8, 2026.

Elidel® (pimecrolimus) [prescribing information]. East Hanover, NJ: Novartis; March 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021302s018lbl.pdf Accessed June 8, 2026.

Entadfi™ (finasteride and tadalafil) [prescribing information]. Miami, FL: Veru Inc. December 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=112bf653-8322-4444-8d4d-03234b11c38c. Accessed June 8, 2026.

Entocort EC® (budesonide) [prescribing information]. Allegan, MI: Perrigo; July 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24f0312f-f768-42db-bf7c-4ba2ee4fc309. Accessed June 8, 2026.

Epaned (enalapril) [prescribing information]. Wilmington, MA: Azurity Pharmaceuticals, Inc. Available at: https://epaned.com/Epaned-Prescribing-Info.pdf. Accessed June 8, 2026.

Epsolay® (benzoyl peroxide) [prescribing information]. Dallas, TX: April 2022. Available from: https://www.galderma.com/us/sites/default/files/2022-03/Epsolay_PI.pdf. Accessed June 8, 2026.

Ermeza® (levothyroxine) [prescribing information]. San Antonio, TX: DPT Laboratories, LTD and Morgantown, WV: Mylan Specialty LP.April 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ceeadb4-18be-46c7-9204-68b4edfbb96b. Accessed June 8, 2026.

Ertaczo® (sertaconazole nitrate) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; January 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021385s005lbl.pdf. Accessed June 8, 2026.

Escitalopram capsules [prescribing information]. Irvine, CA. Allergan USA, Inc. January 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf. Accessed December 9, 2025.

Esgic® (butalbital, acetaminophen and caffeine) [prescribing information]. Greenville, NC: Mayne Pharma; May 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5827155-c339-4f7e-829b-6cf4edc581af. Accessed June 8, 2026.

Estrace cream [prescribing information]. Warner Chilcott Inc. April 2005. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/86069s018lbl.pdf. Accessed June 8, 2026.

Eucrisa^TM(crisaborole) [prescribing information]. Palo Alto, CA: Anacor Pharmaceuticals, Inc.; April 2020. http://labeling.pfizer.com/ShowLabeling.aspx?id=5331 Accessed June 8, 2026.

Evista (raloxifene) [prescribing information]. Indianapolis, IN: Eli Lilly and Co; December 2019. Accessed June 8, 2026.

Evoclin® (clindamycin phosphate) [prescribing information]. Newtown,PA: Prestium Pharma, Inc.; August 2018. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf. Accessed June 8, 2026.

Evoxac (cevimeline) [prescribing information]. Edison, NJ: Daiichi; April 2018. Accessed June 8, 2026.

Exelderm® (sulconazole nitrate) [prescribing information]. Gurgaon, India: Ranbaxy Laboratories Inc., 2013. Accessed June 8, 2026.

Exforge HCT® (amlodipine valsartan and hydrochlorothiazide) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2020.https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/exforge_hct.pdf Accessed June 8, 2026.

Extina® (ketoconazole) [prescribing information]. Newtown, PA: Prestium Pharma, Inc.; January 2014. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ceaee038-9681-45ab-b974-f32b72443022 Accessed June 8, 2026.

Exxua (gepirone) [prescribing information]. Fabre-Kramer Pharmaceuticals; Reviewed September 2023. Available from: https://exxua.com/pdf/exxua-prescribing-information.pdf. Accessed June 8, 2026.

Ezetimibe and atorvastatin [prescribing information]. Morristown, NJ: Althera Pharmaceuticals LLC. Jan 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6375eae7-e159-4fb2-a91c-9aa20ac3c9e1. Accessed June 8, 2026.

Fabior® (tazarotene) [prescribing information]. Greenville, NC: Mayne Pharma; June 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae0afed7-1d60-45fd-a08b-8db094618521. Accessed June 8, 2026.

Fanapt® (iloperidone) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; February 2017. Available from: https://fanaptpro.com/wp-content/uploads/2016/02/Fanapt-Prescribing-Information.pdf. Accessed June 8, 2026.

Felbatol® (felbamate) [prescribing information]. Somerset, NJ: MEDA Pharmaceuticals, Inc. July 2011. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020189s027lbl.pdf. Accessed June 8, 2026.

Femring (estradiol acetate vaginal ring) [prescribing information]. Warner Chilcott Inc. May 2009. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021367s009lbl.pdf. Accessed June 8, 2026.

Fenopron (Fenoprofen calcium) [prescribing information]. Atlanta, GA: Galt Pharmaceuticals, LLC. December 2024. Available at: DailyMed - FENOPRON TM- fenoprofen calcium capsule. Accessed June 8, 2026.

Fenortho™ (fenoprofen) [prescribing information]. Ripley, MS: Sterling-Knight Pharmaceuticals, LLC. March 2017. Accessed June 8, 2026.

Fentora® (fentanyl buccal tablet) [prescribing information]. North Wales, PA: Teva Pharmaceuticals Inc. December 2016. Accessed June 8, 2026.

Fetzima™ (levomilnacipran hydrochloride) [prescribing information]. Parsippany, NJ: Allergan, Inc; October 2019. Available from: https://media.allergan.com/actavis/actavis/media/allergan-pdf-documents/product-prescribing/10092019-FETZIMA-v2_0USPI2220-v2_0MG2220-(clean).pdf. Accessed June 8, 2026.

Finacea® (azelaic acid) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc. July 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207071s000lbl.pdf Accessed June 8, 2026.

Fioricet® with codeine (butalbital, acetaminophen, caffeine and codeine phosphate) [prescribing information]. Morristown, NJ. April 2011. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf Accessed June 8, 2026.

FIRVANQ® [prescribing information]. Wilmington, MA: Azurity Pharmaceuticals, Inc. Available at: 65628-0120_FIRVANQ_PI_REV_05.pdf. Accessed June 8, 2026.

Fleqsuvy™ (baclofen solution) [prescribing information]. Wilmington, MA: Azurity Pharmaceuticals, Inc. February 2022. Available from: https://azurity.com/wp-content/uploads/2022/02/FLEQSUVY-PI-02-04-2022.pdf. Accessed June 8, 2026.

Flolipid (simvastatin) suspension [Package Insert]. Brooksville, FL: Salerno Pharmaceuticals LP. Available at: Microsoft Word - FloLipid Oral Suspension Insert.doc. Accessed June 8, 2026.

Flomax® (tamsulosin) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis US LLC; January 2019. Accessed June 8, 2026.

Flovent HFA/Diskus (fluticasone propionate inhalation aerosol/powder) [prescribing information]. Durham, NC: GlaxoSmithKline. August 2023. Available from: https://www.flovent.com/. Accessed June 8, 2026.

Focalin XR® (dexmethylphenidate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; January 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021802s033lbl.pdf Accessed June 8, 2026.

Forfivo XL® (buproprion) [prescribing information]. Pine Brook, NJ: Almatica Pharma Inc.; December 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6917be04-3eff-be1f-99cc-1a20093a6ef0. Accessed June 8, 2026.

FOSRENOL (lanthanum carbonate) [prescribing information]. Wayne, PA: Shire US Inc. August 2011. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf. Accessed June 8, 2026.

Fulvicin P/G 165 (ultramicrosize griseofulvin tablet) [prescribing information]. Madisonville, LA: Solubiomix, LLC. February 2025. Available at: DailyMed - FULVICIN P/G 165- ultramicrosize griseofulvin tablet. Accessed June 8, 2026.

Gabarone (gabapentin) [prescribing information]. Fairmont, WV: INA Pharmaceutics Inc. December 2024. Available at: DailyMed - GABARONE- gabapentin tablet. Accessed June 8, 2026.

Gelnique® (oxybutynin chloride) [prescribing information]. Madison, NJ: Allergan USA, Inc; March 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57616d79-9e68-4ec7-a25f-ebee07576351. Accessed June 8, 2026.

Gemtesa® (vibegron) [prescribing information]. Irvine, CA: Urovant Sciences, Inc.; December 2020. Available from: https://www.gemtesa.com/sites/default/files/gemtesa-prescribing-information.pdf. Accessed June 8, 2026.

Gimoti® (metoclopramide) [prescribing information]. Solana Beach, CA: Evoke Pharma, Inc; January 2021. Available from: https://evokepharma.com/wp-content/uploads/Prescribing-Information-Gimoti%E2%84%A2-metoclopramide-nasal-spray.pdf. Accessed June 8, 2026.

Gloperba® (colchicine) [prescribing information]. Ferndale, MI: Ferndale Laboratories, Inc. January 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210942s000lbl.pdf. Accessed June 8, 2026.

Glucagen® (glucagon) [prescribing information]. Bagsvaerd, Denmark: Novo Nordisk Inc. June 2020. Available from: https://www.novo-pi.com/glucagenhypokit.pdf. Accessed June 8, 2026.

Glucotrol XL® (glipizide) [prescribing information]. New York, NY: Pfizer; November 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d. Accessed June 8, 2026.

Gocovri® (amantadine) [prescribing information]. Emeryville, CA: Adamas Pharma, LLC; January 2021. Available from: https://www.gocovri.com/pdfs/gocovri-prescribing-information.pdf. Accessed June 8, 2026.

Golytey® (polyethylene glycol 3350 and electrolytes oral solution) [prescribing information]. Holbrook, MA: Braintree Laboratories, Inc.; June 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57d22b0b-1ae0-4203-babc-f3bac17bd1c9. Accessed June 8, 2026.

Gonal-F RFF® (follitropin alfa) [prescribing information]. Darmstadt, DE: EMD Serono, Inc.; January 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aa759a1b-2c1d-438b-bd7e-019a2067699d. Accessed June 8, 2026.

Halcion® (triazolam) [prescribing information]. Kalamazoo, MI: Pharmacia and Upjohn Company LLC; December 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=586 Accessed June 8, 2026.

Halobetasol propionate lotion 0.05% [prescribing information]. San Antonio, TX. Coral Way Pharma, LLC; March 2026. Available from: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4cb1f7b3-c412-6fc7-e063-6394a90a63c9. Accessed June 8, 2026.

Halog® (halcinonide) [prescribing information]. Gurgaon, India: Ranbaxy Laboratories Inc. November 2019. https://pi.lilly.com/us/humalog-pen-pi.pdf Accessed June 8, 2026.

Hysingla™ ER (hydrocodone bitartrate) [prescribing information]. Stamford, CT: Purdue Pharma L.P.; October 2019. Available from: app.purduepharma.com/xmlpublishing/pi.aspx?id=h. Accessed June 8, 2026.

Hyzaar® (losartan potassium and hydrochlorothiazide) [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; November 2019. https://www.merck.com/product/usa/pi_circulars/h/hyzaar/hyzaar_pi.pdf Accessed June 8, 2026.

Ibsrela® (tenapor) [prescribing information]. Fremont, CA: Ardelyx, Inc.; 2021. https://www.ibsrela-hcp.com . Accessed June 8, 2026.

Ibuprofen 300 mg tablet [prescribing information]. Nashville, TN. Westminster Pharmaceuticals, LLC. April 2025. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=2e0f74a5-b8f3-fc81-e063-6394a90a647a. Accessed December 9, 2025.

Ilevro® (nepafenac ophthalmic suspension) [prescribing information]. Fort Worth, Texas: Alcon Laboratories, Inc. January 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6c212466-ff8d-ecfc-ede2-ef8bdcaaf114. Accessed June 8, 2026.

Impeklo (clobetasol propionate) [prescribing information]. Mylan Specialty LP. May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213691s000lbl.pdf. Accessed June 8, 2026.

Impoyz® (clobetasol propionate) [prescribing information]. San Antonio, TX: Primus Pharmaceuticals, Inc; April 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40173654-334e-4618-847b-6a1e030cd2fd. Accessed June 8, 2026.

Inderal® LA (propranolol hydrochloride) [prescribing information]. Cranford, NJ: Akrimax Pharmaceuticals LLC; November 2017. http://labeling.pfizer.com/ShowLabeling.aspx?id=9895 Accessed June 8, 2026.

INDOCIN® [prescribing information]. Wayne, PA: Zyla Life Sciences US Inc. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018332s043lbl.pdf. Accessed June 8, 2026.

Indomethacin suspension [Package Insert]. Baudette, MN: ANI Pharmaceuticals, Inc. Available at: Indomethacin Oral Suspension: Package Insert / Prescribing Info. Accessed June 8, 2026.

Innopran XL® (propranolol hydrochloride) [prescribing information]. Baudette, Minnesota: ANI Pharmaceuticals, Inc; August 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cd5601b3-4d87-4c3b-acac-b476e787609d. Accessed June 8, 2026.

Inspra® (eplerenone) [prescribing information]. New York, NY: Pfizer; August 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a55a39ff-1bd5-428b-a64f-c44262e2f3ed. Accessed June 8, 2026.

Intrarosa (prasterone) [prescribing information]. Endoceutics Inc. November 2016. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf. Accessed June 8, 2026.

Intuniv® ER (guanfacine HCL) [prescribing information]. Exton, PA: Shire US Manufacturing Inc.; December 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022037s019lbl.pdf. Accessed June 8, 2026.

Invega® (paliperidone) [prescribing information]. Raritan, NJ: Janssen Pharmaceuticals, Inc.; January 2019. Available from: https://www.invega.com/prescribing-information.html. Accessed June 8, 2026.

Invokamet® XR (canagliflozin and metformin hydrochloride) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. August 2020. Available from: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVOKAMET+XR-pi.pdf. Accessed June 8, 2026.

Invokana® (canagliflozin) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. August 2020. Available from: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INVOKANA-pi.pdf. Accessed June 8, 2026.

Inzirqo (hydrochlorothiazide powder for suspension) [prescribing information]. Baudette, MN: ANI Pharmaceuticals, Inc. January 2025. Available at: DailyMed - INZIRQO- hydrochlorothiazide powder, for suspension. Accessed June 8, 2026.

Iopidine (apraclonidine hydrochloride ophthalmic solution) [prescribing information]. Nashville, TN: Harrow Eye, LLC. July 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=00f18845-ccde-8678-e063-6294a90a3374. Accessed June 8, 2026.

Istalol® (timolol maleate ophthalmic solution) [prescribing information]. Tampa, FL: Bausch & Lomb Incorporated. March 2022. Available at: https://www.bausch.com/globalassets/pdf/packageinserts/pharma/istalol-package.pdf. Accessed June 8, 2026.

Iyuzeh (latanoprost ophthalmic solution) [prescribing information]. Lexington, MA: Thea Pharma Inc. December 2022. Available at: IYUZEH-Full-Prescribing-Information.pdf. Accessed June 8, 2026.

Jalyn® (dutasteride/tamsulosin) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; December 2020. Accessed June 8, 2026.

Jentadueto® (litagliptan and metformin hydrochloride) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; March 2020. http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Jentadueto/Jentadueto.pdf Accessed June 8, 2026.

Jylamvo® (methotrexate) [prescribing information]. Scotch Plains, NJ: Lukare Medical LLC. November 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212479s000lbl.pdf. Accessed June 8, 2026.

Kapspargo® (metoprolol succinate) [prescribing information]. New Brunswick, NJ. May 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210428s001lbl.pdf. Accessed June 8, 2026.

Kapvay™ (clonidine) [prescribing information]. Oaksville, Ontario: Concordia Pharmaceuticals Inc.; February 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022331s021lbl.pdf. Accessed June 8, 2026.

KATERZIA® (amlodipine) [Package Insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. Available at: Katerzia-Full-Prescribing-Info.pdf. Accessed June 8, 2026.

Kazano® (alogliptan and metformin hydrochloride) [prescribing information]. Lake County, IL: Takeda Pharmaceuticals America, Inc.; June 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203414s012lbl.pdf. Accessed June 8, 2026.

Kenalog® (triamcinolone acetonide) [prescribing information]. Gurgaon, India: Ranbaxy Laboratories Inc., June 2018. https://packageinserts.bms.com/pi/pi_kenalog-40.pdf Accessed June 8, 2026.

Keppra® (levetiracetam) [prescribing information]. Smyrna, GA: UCB Inc.; October 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021035s100,021505s040lbl.pdf. Accessed June 8, 2026.

Ketoprofen [prescribing information]. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=198a4140-f4c0-4478-9157-ee1d68d0bb96. Accessed June 8, 2026.

Khindivi® (hydrocortisone) [prescribing information]. Deer Park, IL: Eton Pharmaceuticals. July 2025. Available at: DailyMed - KHINDIVI- hydrocortisone solution. Accessed June 8, 2026.

Kitabis® (tobramycin) [prescribing information]. Midlothian, VA: Pari Respiratory Equipment, Inc.; July 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=da1e5afd-d707-4af1-8935-8195ba6d769fcf07725ec223. Accessed June 8, 2026.

Klonopin® (clonazepam) [prescribing information]. San Francisco, CA: Genentech USA, Inc. October 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017533s059lbl.pdf. Accessed June 8, 2026.

Kristalose® packet (lactulose) [prescribing information]. Nashville, TN: Cumberland Pharmaceuticals Inc. July 2018. Available at: http://www.kristalose.com/wp-content/uploads/2019/03/Kristalose_PI_July_2018.pdf. Accessed June 8, 2026.

Lamictal® (lamotrigine) [prescribing information]. Philadelphia, PA: GlaxoSmithKline LLC; February 2020. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Lamictal/pdf/LAMICTAL-PI-MG.PDF Accessed June 8, 2026.

Latuda (lurasidone) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc. July 2023. Available at: DailyMed - LATUDA- lurasidone hydrochloride tablet, film coated. Accessed June 8, 2026.

Lescol XL® (fluvastatin sodium) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8a1823e7-26fb-4858-bac7-9e152e5ea16a. Accessed June 8, 2026.

Levitra (vardenafil) [prescribing information]. Whitpany, NJ: Bayer Healthcare Pharmaceuticals Inc; August 2017. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a01def95-c0ef-43b9-bd9e-5565b2385ad3&type=display. Accessed June 8, 2026.

Lexapro® (escitalopram) [prescribing information]. Parsippany, NJ: Allergan, Inc; January 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021323s047lbl.pdf. Accessed June 8, 2026.

Lexette® (halobetasole propionate) [prescribing information]. Greenville, NC: Mayne Pharma. May 2020. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d5d0d307-37ad-4714-ba3f-5343672bc0e7. Accessed June 8, 2026.

Lialda (mesalamine, delayed release). Lexington, MA: Takeda Pharmaceuticals America, Inc. October 2023. Available at: DailyMed - LIALDA- mesalamine tablet, delayed release. Accessed June 8, 2026.

Librax® (clidinium bromide/chlordiazepoxide hydrochloride) [prescribing information]. Bridgewater, NJ: Bausch Health US LLC; February 2021. Accessed June 8, 2026.

Lidoderm® (lidocaine) [prescribing information]. Malvern, PA: Endo Pharmaceuticals Inc.; November 2018. http://www.endo.com/File%20Library/Products/Prescribing%20Information/LIDODERM_prescribing_information.html Accessed June 8, 2026.

Likmez™ (metronidazole) [prescribing information]. Hauppauge, NY: Saptalis Pharmaceuticals LLC. January 2024. Available at: https://likmez.com/wp-content/uploads/2024/02/final-labeling-text-Kesin-01-2024.pdf. Accessed June 8, 2026.

Lipitor® (atorvastatin) [prescribing information]. Collegeville, PA: Parke-Davis Div of Pfizer Inc; November 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=587 Accessed June 8, 2026.

Lithobid (lithium carbonate) [prescribing information]. Baudette, MN: ANI Pharmaceuticals, Inc. October 2022. Available at: DailyMed - LITHOBID- lithium carbonate tablet, film coated, extended release. Accessed June 8, 2026.

Livalo® (pitavastatin) [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; September 2020. https://www.kowapharma.com/documents/LIVALO_PI_CURRENT.pdf Accessed June 8, 2026.

Locoid® (hydrocortisone butyrate) [prescribing information]. Cumberland, RI: Onset Dermatologics LLC; November 2014. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020769s014lbl.pdf Accessed June 8, 2026.

Lorzone® (chlorzoxazone) [prescribing information]. Bridgewater, NJ: Vertical Pharmaceuticals, LLC; October 2018. Accessed June 8, 2026.

Lotrel® (amlodipine and benazepril) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.; April 2021. Available from: https://www.novartis.us/sites/www.novartis.us/files/lotrel.pdf. Accessed June 8, 2026.

Lotronex® (alosetron hydrochloride) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc. January 2019. Available from: https://www.lotronex.com/hcp/_docs/PI%20v.Sebela_Final.pdf. Accessed June 8, 2026.

Lovaza® (omega-3-acid ethyl esters) [prescribing information]. Research Triangle Park, NC. GlaxoSmithKline; April 2019. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Lovaza/pdf/LOVAZA-PI-PIL.PDF Accessed June 8, 2026.

Lunesta® (uneszopiclone) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; August 2019. http://www.lunesta.com/PostedApprovedLabelingText.pdf Accessed June 8, 2026.

Luxiq® (betamethasone valerate) [prescribing information]. Newtown,PA: Prestium Pharma, Inc.; May 2014. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51fe8c40-5e56-4449-8995-f227c8bb5a50 Accessed June 8, 2026.

Luzu® (luliconazole) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; April 2020. https://www.bauschhealth.com/Portals/25/Pdf/PI/Luzurx-PI.pdf Accessed June 8, 2026.

Lyrica® (pregabalin) [prescribing information]. Belleville, NJ: U.S. Pharmaceuticals; August 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ce1a4b9d-3127-4416-8bf2-fee5899fc0ba. Accessed June 8, 2026.

Lyvispah™ (baclofen) [prescribing information]. Roswell, GA: Saol Therapeutics, Inc. November 2021. Available from: https://www.lyvispah.com/public/docs/Lyvispah-Prescribing-Information.pdf. Accessed June 8, 2026.

Mavenclad® (cladribine) [prescribing information]. Rockland, MA: EMD Serono, Inc. April 2019. Available at: https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/mavenclad-pi.pdf. Accessed June 8, 2026.

Menopur® (menotropin) [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; May 2019. www.ferringusa.com/wp-content/uploads/2019/04/Menopur-PI-Rev.-05.2018-20Mar2019.pdf. Accessed June 8, 2026.

Mestinon (Pyridostigmine) Oral Solution [Package Insert]. Chino, CA: Apnar Pharma LP. Available at: Pyridostigmine Oral Solution: Package Insert / Prescribing Info. Accessed June 8, 2026.

Metadate CD (methylphenidate ER). [prescribing information]. Lannett Company, Inc. October 2023. Available at: DailyMed - METADATE CD- methylphenidate hydrochloride capsule, extended release (nih.gov). Accessed June 8, 2026.

Micardis® HCT (telmisartan and hydrochlorothiazide) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; February 2018. https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Micardis%20HCT/MicardisHCT-US2.PDF Accessed June 8, 2026.

Micromedex. Available at http://www.micromedexsolutions.com/. Accessed June 8, 2026.

Millipred (Prednisolone) [prescribing information]. Greenville, SC: Laser Pharmaceuticals, LLC. January 2009. Available at: Prednisolone.pdf. Accessed June 8, 2026.

Minivelle® (estradiol transdermal system) [prescribing information]. Miami, FL: Noven Pharmaceuticals Inc; October 2021. Accessed June 8, 2026.

Minocin® (minocycline hydrochloride) [prescribing information]. Cumberland, RI: Onset Dermatologics LLC; 2017. Accessed June 8, 2026.

Minolira™ (minocycline hydrochloride extended release) [prescribing information]. Princeton, NJ. Promius Pharma, LLC. May 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209269s000lbl.pdf. Accessed June 8, 2026.

Mirvaso® (brimonidine) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P. November 2017. https://www.galderma.com/us/sites/g/files/jcdfhc341/files/2018-11/MirvasoPI.pdf Accessed June 8, 2026.

Mitigare® (colchicine) [prescribing information]. Memphis, TN: Hikma Americas Inc.; July 2019. https://www.mitigare.com/wp-content/uploads/mitigare-pi.pdf Accessed June 8, 2026.

Mobic® (meloxicam) [prescribing information].Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; February 2020. https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Mobic/MobicTabs7-5-15mg.PDF Accessed June 8, 2026.

Motegrity™ (prucalopride) [prescribing information]. Lexington, MA: Shire US Inc. November 2020. Available from: https://www.shirecontent.com/PI/PDFs/MOTEGRITY_USA_ENG.pdf. Accessed June 8, 2026.

Motpoly XR (lacosamide) [prescribing information]. Piscataway, NJ: Aucta Pharmaceuticals, Inc. May 2023. Available at: https://motpolyxr.com/pdf/Motpoly%20XR%20Prescribing%20Information.pdf. Accessed June 8, 2026.

Moviprep® (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals, LLC; May 2019. Available from: https://shared.salix.com/shared/pi/moviprep-pi.pdf?id=8251081. Accessed June 8, 2026.

MS Contin (morphine sulfate) [prescribing information]. Stamford, CT: Purdue Pharma L.P.; October 2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf. Accessed June 8, 2026.

Mysoline® (primidone tablets) [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC; July 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=af593171-dabb-4ea3-b44c-89ed457b2c46. Accessed June 8, 2026.

Mytesi™ (crofelemer) [prescribing information]. San Francisco, CA: Napo Pharmaceuticals, Inc.; November 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202292s006lbl.pdf. Accessed June 8, 2026.

Nalfon® (fenoprofen) [prescribing information]. Ridgeland, MS: Xspire Pharma. June 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf Accessed June 8, 2026.

Nalocet® (oxycodone and acetaminophen tablets) [prescribing information]. Las Vegas, NV. Forte Bio-Pharma LLC. December 2020. Available from: https://fortebiopharma.com/wp-content/uploads/2021/01/Nalocet-PI.pdf. Accessed June 8, 2026.

Naprelan® (naproxen sodium) [prescribing information]. Florham Park, NJ: Shionogi. November 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020353s028lbl.pdf. Accessed June 8, 2026.

Naprosyn® (naproxen) [prescribing information]. Phoenixville, PA: Genentech, Inc.; March 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017581s113,018164s063,020067s020lbl.pdf Accessed June 8, 2026.

Naproxen suspension [Package Insert]. Novitium Pharma LLC. Available at: DailyMed - NAPROXEN ORAL SUSPENSION- naproxen oral suspension. Accessed June 8, 2026.

Neoral (cyclosporine) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. July 2024. Available at: DailyMed - NEORAL- cyclosporine capsule, liquid filled NEORAL- cyclosporine solution. Accessed June 8, 2026.

Nesina® (alogliptan) [prescribing information]. Lake County, IL: Takeda Pharmaceuticals America, Inc.; June 2019. https://general.takedapharm.com/NESINAPI Accessed June 8, 2026.

Neurontin® (gabapentin) [prescribing information]. New York, NY: Parke-Davis of Pfizer, Inc. April 2020. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=630. Accessed June 8, 2026.

Nevanac® (nepafenac ophthalmic suspension) [prescribing information]. Fort Worth, TX: Alcon Laboratories, Inc. December 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021862s013lbl.pdf. Accessed June 8, 2026.

Nexiclon™ XR (clonidine) [prescribing information]. Athens, GA: Athena Bioscience, LLC. March 2022. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dad35a6f-d57e-f302-e053-2995a90a9efb. Accessed June 8, 2026.

Niaspan® (niacin extended-release tablets) [prescribing information]. North Chicago, IL: AbbVie Inc. September 2020. Available at: https://www.rxabbvie.com/pdf/niaspan.pdf. Accessed June 8, 2026.

NITROFURANTOIN oral suspension [Package Insert]. Delran, NJ: Carnegie Pharmaceuticals LLC. Available at: Nitrofurantoin Oral Suspension: Package Insert / Prescribing Info. Accessed June 8, 2026.

Noritate® (metronidazole cream) [prescribing information]. Bridgewater, NJ: Dermik Laboratories. March 2018. Accessed June 8, 2026.

Norliqva® (amlodipine) [prescribing information]. Farmville, NC: CMP Pharma, Inc. February 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214439s000lbl.pdf. Accessed June 8, 2026.

Nortriptyline Oral Solution [prescribing information]. Greenville, SC: Pharmaceutical Associates, Inc. Available at: Nortriptyline Oral Solution: Package Insert / Prescribing Info. Accessed June 8, 2026.

Norvasc® (amlodipine besylate) [prescribing information]. New York, NY: Pfizer, Inc. March 2017. Available at: http://labeling.pfizer.com/ShowLabeling.aspx?id=562. Accessed June 8, 2026.

Nuvessa® (metronidazole) [prescribing information]. Florham Park, NJ: Exeltis USA, Inc.; April 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b6ff39d-f84b-43b3-9b07-c0521c6d7968. Accessed June 8, 2026.

Nuvigil® (armodafinil) [prescribing information]. North Wales, PA; Teva Pharmaceuticals. November 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021875s023lbl.pdf Accessed June 8, 2026.

Olux®/ Olux-E® (clobetasol propionate) [prescribing information]. Newtown,PA: Prestium Pharma, Inc.; April 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021142s022lbl.pdf Accessed June 8, 2026.

Onexton® (clindamycin phosphate benzoyl peroxide) [prescribing information]. Bridgewater, NJ: Bausch Health US. LLC. April 2020. Available at: https://pi.bauschhealth.com/globalassets/BHC/PI/Onexton-PI.pdf. Accessed June 8, 2026.

Ongentys (opicapone) [prescribing information]. San Diego, CA: Neurocrine Biosciences. April 2020. Available at: https://www.neurocrine.com/assets/ONGENTYS-PI.pdf. Accessed June 8, 2026.

Onglyza® (saxagliptin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. October 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c5116390-e0fe-4969-94cb-e9de5165fbab. Accessed June 8, 2026.

Ontralfy™ (tizanidine hydrochloride) [prescribing information]. Greenville, SC. Rosemont Pharmaceuticals, LLC; October 2025. Available from: https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=ONTRALFY Accessed June 8, 2026.

Onyda XR (clonidine ER suspension) [prescribing information]. Monmouth Junction, NJ: Tris Pharma, Inc. July 2024. Available at: ONYDA XR Full Prescribing Information.pdf. Accessed June 8, 2026.

OPIPZA (aripiprazole) [prescribing information]. Xiamen, Fujian, China: Xiamen Pharmaceutical Co., Ltd. July 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216655s000lbl.pdf. Accessed June 8, 2026.

Opzelura® (ruxolitinib) [package insert]. Wilmington, DE. Incyte Corporation. January 2023. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24da5509-6631-4795-9d42-273faecd08e7. Accessed June 8, 2026.

Orfadin® (nitisinone) [prescribing information]. Sweden: Apotek Produktion & Labroatorier AB. May 2019. Available at: https://www.orfadin.com/pdf/full-prescribing-information.pdf. Accessed June 8, 2026.

Orphenadrine [prescribing information]. 3M Pharmaceuticals. October 2006. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/012157s028lbl.pdf. Accessed June 8, 2026.

Ortikos™ (budesonide extended-release) [prescribing information]. Gujarat, India: Sun Pharmaceuticals Industries Ltd.; October 2019. Available from: www.ferringusa.com/wp-content/uploads/2020/07/Ortikos-PI_6794-02.pdf. Accessed June 8, 2026.

Orudis (ketoprofen) [package insert]. Canton, MS. Allegis Pharmaceuticals, Inc., December 2025. Available from: Orudis: Package Insert / Prescribing Information. Accessed June 8, 2026.

Oseni® (alogliptan and pioglitazone) [prescribing information]. Lake County, IL: Takeda Pharmaceuticals America, Inc.; June 2019. https://general.takedapharm.com/OSENIPI Accessed June 8, 2026.

Oxaydo (oxycodone HCl) [prescribing information]. Egalet US Inc. December 2016. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf. Accessed June 8, 2026.

Oxistat® (oxiconazole) [prescribing information]. Princeton, NJ: PharmaDerm a division of Fougera Pharmaceuticals Inc.; 2012. Accessed June 8, 2026.

Oxtellar XR® (oxcarbazepine extended-release) [prescribing information]. Ontario, Canada; Patheon Inc. December 2018. Available from: https://oxtellarxr.com/assets/OxtellarXRPrescribingInformation.pdf. Accessed June 8, 2026.

Oxycodone Oral Solution – VistaPharm Medication Guide. Available at http://online.factsandcomparisons.com/MedGuide/597240.pdf. Accessed June 8, 2026.

Oxytrol® (oxybutynin) [prescribing information]. Madison, NJ: Allerga USA, Inc; August 2016. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8cdc5b4d-ff8d-4010-97d7-313422a0b868. Accessed June 8, 2026.

Ozobax ™(baclofen) [package insert]. Athens, Georgia: Metacel Pharmaceuticals, LLC.; May 2020. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=92153f69-bc9b-4bef-9a8e-751effde5c7e&type=display. Accessed June 8, 2026.

Pamelor™ (nortriptyline) [prescribing information]. Hazelwood, MO: Mallinckrodt Inc. October 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf. Accessed June 8, 2026.

Pancreaze® (pancrelipase) [prescribing information]. Campbell, CA: Vivus, Inc. March 2020. Available at: https://pancreaze.com/wp-content/uploads/2018/12/PANCREAZE-pi.pdf. Accessed June 8, 2026.

Pandel® (hydrocortisone probutate) [prescribing information]. Princeton, NJ: PharmaDerm a division of Fougera Pharmaceuticals Inc.; April 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=361338e6-d719-4bea-aca0-7dd591fcfa08 Accessed June 8, 2026.

Pentasa (mesalamine) [prescribing information]. Cambridge, MA: Takeda Pharmaceuticals America, Inc. July 2024. Available at: DailyMed - PENTASA- mesalamine capsule. Accessed June 8, 2026.

Pepcid® (famotidine) [prescribing information]. Bridgewater, NJ: Valent Pharmaceuticals North America LLC; November 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a06502d9-7903-4f37-833e-e5763d502def. Accessed June 8, 2026.

Pertzye® (pancrelipase) [prescribing information]. Bethlehem, PA: Digestive Care, Inc. March 2020. Available at: https://resources.chiesiusa.com/Pertzye/PERTZYE_PI.pdf. Accessed June 8, 2026.

Plaquenil (hydroxychloroquine) [prescribing information]. Pulaski, TN: AvKARE Inc; July 2016. Accessed June 8, 2026.

Plavix® (clopidogrel tablets) [prescribing information]. Bridgewater, NJ: Bristol-Myers Squib/Sanofi Pharmaceuticals Partnership; March 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01b14603-8f29-4fa3-8d7e-9d523f802e0b. Accessed June 8, 2026.

Plegridy® (peginterferon beta-1a) [prescribing information]. Cambridge, MA: Biogen Inc. July 2023. Available at: plegridy-prescribing-information.pdf. Accessed June 8, 2026.

Plenvu® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride for oral solution) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals, LLC; May 2019. Available from: https://shared.salix.com/shared/pi/plenvu-pi.pdf. Accessed June 8, 2026.

Pokonza (potassium chloride) [prescribing information]. Hazlet, NJ: Carwin Pharmaceutical Associates, LLC. March 2024. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7c5cc705-e5da-4487-86c9-9d545a95afb4. Accessed June 8, 2026.

Pradaxa® (dabigatran etexilate) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. June 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9. Accessed June 8, 2026.

Pramosone ® (hydrocortisone acetate pramoxine hydrochloride) [prescribing information]. Roswell, GA: Sebela Pharmaceuticals Inc; December 2017. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b. Accessed June 8, 2026.

Pred Forte® (prednisolone acetate ophthalmic suspension, USP) [prescribing information]. Madison, NJ: Allergan USA, Inc; May 2020. Available from: https://www.rxabbvie.com/pdf/pred-forte_pi.pdf. Accessed June 8, 2026.

Pristiq® (desvenlafaxine succinate) [prescribing information]. Collegeville, PA: Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.; November 2018. Available from: http://labeling.pfizer.com/showlabeling.aspx?id=497. Accessed June 8, 2026.

Prograf (tacrolimus) [prescribing information]. Northbrook, IL: Astellas Pharma US. Inc. August 2023. Available at: DailyMed - PROGRAF- tacrolimus capsule, gelatin coated PROGRAF- tacrolimus injection, solution PROGRAF- tacrolimus granule, for suspension. Accessed June 8, 2026.

Prolate™ (oxycodone and acetaminophen) [prescribing information]. Las Vegas, NV: Forte Bio-Pharma LLC; January 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9cbbfa94-37b9-9652-e053-2995a90a736b. Accessed June 8, 2026.

Prolensa (bromfenac sodium) [prescribing information]. Bridgewater, NJ: Bausch & Lomb Americas, Inc. Jan 2023. Available at: DailyMed - PROLENSA- bromfenac sodium solution/ drops. Accessed June 8, 2026.

Protopic® (tacrolimus) [prescribing information]. Deerfield, IL: Astellas Pharma US, Inc; November 2011. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf Accessed June 8, 2026.

Proventil® (albuterol) [prescribing information]. Kenilworth, NJ: Merck Sharp & Dohme Corp; September 2017. https://www.merck.com/product/usa/pi_circulars/p/proventil_hfa/proventil_hfa_doseindicator_pi.pdf Accessed June 8, 2026.

Provigil® (modafinil) [prescribing information]. Fazer, PA: Cephalon, Inc., January 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020717s037s038lbl.pdf Accessed June 8, 2026.

Prozac® (fluoxetine hydrochloride) [prescribing information]. Indianapolis, IN: Dista Products Company; April 2020. http://pi.lilly.com/us/prozac.pdf Accessed June 8, 2026.

Pruradik (crotamiton) [prescribing information]. San Antionio TX: Trifluent Pharm, LLC. May 2025. Available at: PRURADIK ™LOTION. Accessed June 8, 2026.

Pulmicort Respules® (budesonide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; October 2019. Available from: https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/a081315f-22e6-48a4-bf51-7a8ed1efa269/a081315f-22e6-48a4-bf51-7a8ed1efa269_viewable_rendition__v.pdf. Accessed June 8, 2026.

QBRELIS® (lisinopril) [Package Insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. Available at: Qbrelis-Prescribing-Info.pdf. Accessed June 8, 2026.

Qdolo (tramadol hydrochloride) [prescribing information]. Athena Bioscience, LLC. September 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214044Orig1s000ltr.pdf. Accessed June 8, 2026.

Qelbree® (viloxazine) [prescribing information]. Rockville, MD: Supernus Pharmaceuticals, Inc; April 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aedf408d-0f84-418d-9416-7c39ddb0d29a. Accessed June 8, 2026.

Qtern® (dapagliflozin and saxagliptin) [prescribing information]. Wilmington DE, AstraZeneca Pharmaceuticals LP. January 2020. https://www.azpicentral.com/qtern/qtern.pdf#page=1 Accessed June 8, 2026.

Qudexy® XR (topiramate extended release) [prescribing information]. Maple Grove, MN: Upsher-Smith Laboratories, LLC. February 2020. Available from: www.upsher-smith.com/wp-content/uploads/QXR-MktgInsert.pdf. Accessed June 8, 2026.

Questran® (cholestyramine powder) [prescribing information]. Chestnut Ridge, NY: Par Pharmaceutical; April 2016. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=362ddd91-a63f-4ec6-841a-75785dd208c8. Accessed June 8, 2026.

Quillichew ER™ (methylphenidate) [prescribing information]. Cupertino, CA: NextWave Pharmaceuticals, Inc.; August 2018. http://labeling.pfizer.com/ShowLabeling.aspx?id=2577 Accessed June 8, 2026.

Quillivant XR® (methylphenidate) [prescribing information]. Cupertino, CA: NextWave Pharmaceuticals, Inc.; August 2018. http://labeling.pfizer.com/showlabeling.aspx?id=965 Accessed June 8, 2026.

Qvar Redihaler® (beclomethasone dipropionate HFA) [prescribing information]. Frazer, PA: Teva Respiratory, LLC. January 2021. Available from: https://www.qvar.com/globalassets/qvar/qvar-redihaler-pi.pdf. Accessed June 8, 2026.

Raldesy (trazodone) [prescribing information]. Parsippany, NJ: Validus Pharmaceuticals LLC. January 2025. Available at: Microsoft Word - raldesy-brand-labeling-text-pi-clean.docx. Accessed June 8, 2026.

Rapaflo (silodosin) [prescribing information]. Madison, NJ: Allergan USA, Inc; December 2020. Available from: https://www.rxabbvie.com/pdf/rapaflo_pi.pdf. Accessed June 8, 2026.

Rayaldee® (calcifediol) [prescribing information]. Miami, FL: OPKO Pharmaceuticals LLC; December 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208010s005lbl.pdf. Accessed June 8, 2026.

Rayos® (prednisone) [prescribing information]. Deerfield, IL: Horizon Therapeutics USA Inc. March 2021. Available at: https://www.hzndocs.com/RAYOS-Prescribing-Information.pdf. Accessed June 8, 2026.

Rebif® (interferon beta-1a) [prescribing information]. Billerica, MA: EMD Serono, Inc.; October 2020. https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/rebif-pi.pdf Accessed June 8, 2026.

RECTIV (nitroglycerin) [prescribing information]. North Chicago, IL: AbbVie Inc. July 2024.Available at: Rectiv - uspi-nitroglycerin-clean - 7-23-24. Accessed June 8, 2026.

Relafen DS™ (nabumetone) [package insert] Hazlet, New Jersey. Carwin Pharmaceutical Associates, LLC. January 2020. Available at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a9a0af85-6c43-4a2d-ba75-0be4ca64c931&type=display. Accessed June 8, 2026.

Relexxii® (methylphenidate hydrochloride extended-release tablets) [prescribing information]. Alpharetta, GA: Vertical Pharmaceuticals, LLC; November 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7677cf9-95e0-4091-ac51-8f237c3f2635. Accessed June 8, 2026.

Relistor® (methylnaltrexone) [prescribing information]. Raleigh, NC: Salix Pharmaceuticals, Inc.; April 2020. https://shared.salix.com/shared/pi/relistor-pi.pdf?id=8251081 Accessed June 8, 2026.

Reltone™ (ursodiol capsules) [prescribing information]. Las Vegas, NV. Intra-Sana Laboratories LLC; November 2020. Available at: https://intrasanalaboratories.com/wp-content/uploads/2021/07/Reltone-PI-02-17-21.pdf. Accessed June 8, 2026.

Restoril™ (temazepam) [prescribing information]. UK: Mallinckrodt, Inc September 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018163s064lbl.pdf Accessed June 8, 2026.

Retin-A Micro® (tretinoin) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2016. Accessed June 8, 2026.

Retin-A® (tretinoin) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2016. Accessed June 8, 2026.

Rhofade® (oxymetazoline) [prescribing information]. Irvine CA: Allergan. November 2019. Available from: https://www.allergan.com/assets/pdf/rhofade_pi.pdf. Accessed June 8, 2026.

Riomet (Metformin) Oral Solution [Package Insert]. Somerset, NJ: Micro Labs USA, Inc. Available at: Metformin Oral Solution: Package Insert / Prescribing Info. Accessed June 8, 2026.

Ritalin LA® (methylphenidate HCL) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; November 2019. https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ritalin_la.pdf Accessed June 8, 2026.

Rozerem® (ramelteon) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America, Inc; November 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9de82310-70e8-47b9-b1fc-6c6848b99455. Accessed June 8, 2026.

Rytary™ (levodopa and carbidopa) [prescribing information]. Hayward, CA: Impax Specialty Pharma; December 2019. http://documents.impaxlabs.com/rytary/pi.pdf Accessed June 8, 2026.

Sancuso (granisetron transdermal system) [prescribing information]. Bedminster, NJ: Kyowa Kirin, Inc. July 2022. Available at: https://sancuso.com/files/Sancuso_Promotional_PI.pdf. Accessed June 8, 2026.

Saphris® (asenapine maleate) [prescribing information]. Parsippany, NJ: Allergan USA, Inc,; February 2017. https://www.allergan.com/assets/pdf/saphris_pi Accessed June 8, 2026.

Sdamlo® (amlodipine) [prescribing information]. Brielle, NJ. Pangea Pharmaceuticals, LLC; February 2026. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886a7f97-60a4-4206-a6c7-5206069ed487 Accessed June 8, 2026.

Secuado® (asenapine film) [prescribing information]. Japan: Hisamitsu Pharmaceutical Co., Inc. October 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=685eaf44-5944-4f38-afba-0a4fc0b3462b&type=display. Accessed June 8, 2026.

Seglentis® (celecoxib and tramadol) [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021. https://www.seglentis.com. Accessed June 8, 2026.

Segluromet™ (ertuglifozin and metformin hydrochloride) [prescribing information]. Whitehouse Station, NJ. Merck & Co., Inc. February 2021. https://www.merck.com/product/usa/pi_circulars/s/segluromet/segluromet_pi.pdf Accessed June 8, 2026.

Sensipar® (cinacalcet) [prescribing information]. Thousand Oaks, CA: Amgen Inc; December 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45028573-13c4-4c8b-ae62-6c75bba97c81Accessed June 8, 2026.

Seysara™ (sarecycline) [prescribing information]. Exton, PA: Almirall, Inc. June 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209521s007lbl.pdf. Accessed June 8, 2026.

Silenor® (doxepin) [prescribing information]. Morristown, NJ: Pernix Therapeutics; August 2019. https://www.silenor.com/Content/pdf/prescribing-information.pdf Accessed June 8, 2026.

Singulair® (montelukast) [prescribing information]. Jersey City, NJ: Organon LLC; June 2021. Accessed June 8, 2026.

Skelaxin® (metaxalone) [prescribing information]. Collegeville, PA: Pfizer Laboratories Div Pfizer Inc; 2017. Accessed June 8, 2026.

Soaanz® (torsemide) [prescribing information]. Vienna, VA: Sarfez Pharmaceuticals Inc; June 2021. https://www.sarfezpharma.com. Accessed June 8, 2026.

Solodyn® (minocycline) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; September 2017. https://www.bauschhealth.com/Portals/25/Pdf/PI/Solodyn-PI.Pdf Accessed June 8, 2026.

Solosec® (secnidazole) [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc.; July 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=551e43d5-f700-4d6e-8029-026f8a8932ff. Accessed June 8, 2026.

Soma® (carisprodol) [prescribing information]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2013. Accessed June 8, 2026.

Soolantra® (ivermectin) [prescribing information]. Fort Worth, TX: Galderma Laboratories, L.P. July 2018. https://www.galderma.com/us/sites/g/files/jcdfhc341/files/2019-01/Soolantra_Cream_PI.pdf Accessed June 8, 2026.

Sorilux® (calcipotriene foam) [prescribing information]. Greenville, NC: Mayne Pharma. December 2022. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe. Accessed June 8, 2026.

Sovuna (hydroxychloroquine sulfate) [prescribing information]. Baudette, MN: Ani Pharmaceuticals Inc. April 2024. Available at: DailyMed - SOVUNA- hydroxychloroquine sulfate tablet, film coated (nih.gov). Accessed June 8, 2026.

Sprix® (ketorolac tromethamine) [prescribing information]. Wayne, PA: Zyla Life Sciences US Inc; April 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97005a1c-167e-4676-bae7-e49b38c36f9e. Accessed June 8, 2026.

Steglatro™ (ertuglifozin) [prescribing information]. Whitehouse Station, NJ. Merck & Co., Inc. February 2021. https://www.merck.com/product/usa/pi_circulars/s/steglatro/steglatro_pi.pdf Accessed June 8, 2026.

Steglujan™ (ertuglifozin and sitagliptin) [presecribing information]. Whitehouse Station, NJ. Merck & Co., Inc. February 2021. https://www.merck.com/product/usa/pi_circulars/s/steglujan/steglujan_pi.pdf Accessed June 8, 2026.

Stendra (avanafil) [prescribing information]. Mopuntain View, CA. Vivus, Inc; August 2018. Available from: https://www.stendra.com/wp-content/documents/Stendra-PI-Mist.pdf. Accessed June 8, 2026.

Stendra (avanafil) [prescribing information]. Piscataway, NJ: Camber Pharmaceuticals, Inc. July 2024. Available at: https://www.drugs.com/pro/avanafil.html. Accessed June 8, 2026.

Strattera® (atomoxetine) [prescribing information]. Indianapolis, IN: Eli Lilly and Company; February 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021411s049lbl.pdf. Accessed June 8, 2026.

SymlinPen® (pramlintide acetate) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2019. https://www.azpicentral.com/symlin/symlin.pdf#page=1 Accessed June 8, 2026.

SYNDROS® (dronabinol) [prescribing information]. Chandler, AZ: Benuvia Therapeutics Inc. July 2020. Available at: Syndros-Package-Insert-2021-1.pdf. Accessed June 8, 2026.

Synlar® (fluocinolone acetonide) [prescribing information]. Mahwah, NJ: Glenmark Pharmaceuticals; 2017. Accessed June 8, 2026.

Synthroid (levothyroxine) [prescribing information]. North Chicago, IL: AbbVie Inc. February 2024. Available at: DailyMed - SYNTHROID- levothyroxine sodium tablet. Accessed June 8, 2026.

Syprine® (trientine hydrochloride) [prescribing information], Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; December 2016. Available from: https://www.bauschhealth.com/Portals/25/Pdf/PI/Syprine-PI.pdf. Accessed June 8, 2026.

Targadox™ (doxycycline) [prescribing information]. Scottsdale, AZ: Journey Medical Corporation; 2016. Accessed June 8, 2026.

Tascenso ODT™ (fingolimod) [prescribing information]. Cambridge, United Kingdom: Cycle Pharmaceuticals Ltd. December 2022. Available from: https://tascenso.com/wp-content/uploads/2023/02/Tascenso-ODT-PI-15-Dec-2022.pdf. Accessed June 8, 2026.

Tasmar (tolcapone) [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. October 2025. Available at: DailyMed - TASMAR- tolcapone tablet, film coated

Tazorac® (tazorotene) [prescribing information]. Irvine, CA: Allergan. July 2017. Accessed June 8, 2026.

Tecfidera (dimethyl fumarate0 [prescribing information]. Biogen Idec Inc. March 2013. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204063lbl.pdf. Accessed June 8, 2026.

Tegretol® (carbamazepine) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. February 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf. Accessed June 8, 2026.

Tegretol® XR (carbamazepine extended-release) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. February 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016608s101,018281s048lbl.pdf. Accessed June 8, 2026.

Tenorectic® (atenolol and chlorthalidone) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017. Accessed June 8, 2026.

Tenormin® (atenolol) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2017. Accessed June 8, 2026.

Texacort® (hydrocortisone) [prescribing information]. San Antonio, TX: Mission Pharmacal Company; May 2019. Available from: https://texacort.com/wp-content/uploads/2020/08/file1.pdf. Accessed June 8, 2026.

Tezruly (terazosin) [prescribing information]. Baudette, MN: ANI Pharmaceuticals, Inc. April 2025. Available at: DailyMed - TEZRULY- terazosin solution. Accessed June 8, 2026.

Thiola EC (tiopronin DR) [prescribing information]. San Antonia, TX: Mission Pharmacal Company. January 2024. Available at: DailyMed - THIOLA EC- tiopronin tablet, delayed release. Accessed June 8, 2026.

Thyquidity™ (levothyroxine sodium oral solution) [prescribing information]. Largo, FL: VistaPharm, inc.; December 2020. Available from: https://www.thyquidity.com/pdf/Prescribing-Information.pdf. Accessed June 8, 2026.

Timoptic® Ocudose (timolol maleate ophthalmic solution) [prescribing information]. Whitehouse Statation, NJ: Merck & Co. Inc. July 2005. Available at: https://www.merck.com/product/usa/pi_circulars/t/timoptic/timoptic_ocudose_pi.pdf. Accessed June 8, 2026.

Tirosint (levothyroxine sodium) [prescribing information]. Lugano, Switzerland. Institut Biochimique SA. June 2018. https://tirosint.com/wp-content/uploads/2019/04/Tirosint-PI.pdf. Accessed June 8, 2026.

Tivorbex™ (indomethacin) [prescribing information]. Philadelphia, PA: Iroko Pharmaceuticals, LLC. February 2014. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204768s000lbl.pdf. Accessed June 8, 2026.

Tizanidine hydrochloride capsules [prescribing information]. San Antonio, TX. Trifluent Pharma, LLC; February 2026. Available from: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4a2cf456-58c5-c26d-e063-6294a90a0b24. Accessed June 8, 2026.

Tobi® (tobramycin) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; October 2018. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f9e516-6bf6-4e30-8dde-8833c25c2560. Accessed June 8, 2026.

Topamax® (topiramate capsules) [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; May 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020505s057_020844s048lbl.pdf Accessed June 8, 2026.

Topicort® (desoximetasone) [prescribing information]. Hawthorne, NY: Taro Pharmaceuticals U.S.A., Inc.; 2016. Accessed June 8, 2026.

Toviaz® (fesoterodine fumarate) [prescribing information]. Collegeville, PA: Pfizer Laboratories Div Pfizer Inc; November 2017. http://labeling.pfizer.com/showlabeling.aspx?id=540 Accessed June 8, 2026.

Tradjenta® (linagliptan) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; March 2020. https://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Tradjenta/Tradjenta.pdf?DMW_FORMAT=pdf Accessed June 8, 2026.

Travatan Z® (travoprost) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=028455e0-ae77-4213-8819-3b58ef7d6a14. Accessed June 8, 2026.

Trianex® (triamcinolone acetonide ointment) [prescribing information]. Farmville, NC: CPM Pharma, Inc. April 2019. Available from: https://www.trianexointment.com/wp-content/themes/bridge-child/docs/TRIANEX_Prescribing%20Information.pdf. Accessed June 8, 2026.

Tribenzor® (olmesartan medoxomil/amlodipine/hydrochlorothiazide) [prescribing information]. Parsippany, NJ: Daiichi Sankyo, Inc.; May 2020. https://dsi.com/prescribing-information-portlet/getPIContent?productName=Tribenzor&inline=true Accessed June 8, 2026.

Tridacaine (lidocaine patch) [prescribing information]. San Antonio, TX: Trifluent Pharma. July 2024. Available at: DailyMed - TRIDACAINE III- lidocaine patch. Accessed June 8, 2026.

Trileptal (oxcarbazepine0 [prescribing information]. Novartis Pharmaceuticals Corporation. March 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021014s036lbl.pdf. Accessed June 8, 2026.

Trilipix® (fenofibric acid) [prescribing information]. North Chicago, IL: AbbVie Inc; June 2021. Available from: https://www.rxabbvie.com/pdf/trilipix_pi.pdf. Accessed June 8, 2026.

Trintellix™ (vortioxetine) [prescribing information]. Lake County, IL: Takeda Pharmaceuticals America, Inc.; January 2021. https://general.takedapharm.com/TRINTELLIXPI Accessed June 8, 2026.

Tritocin® (triamcinolone) [prescribing information]. Suwanee, GA: Eckson Labs, LLC; April 2021. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c11eeaee-ca00-20d0-e053-2a95a90a5b86026f8a8932ff. Accessed June 8, 2026.

Trokendi XR® (topiramate ER capsules) [prescribing information]. Winchester, KY: Catalent Pharma Solutions. November 2020. Available from: https://www.trokendixr.com/assets/TrokendiXRPrescribingInformation.pdf. Accessed June 8, 2026.

Trulance™ (plecanatide) [prescribing information]. New York, NY: Synergy Pharmaceuticals Inc.; October 2020. https://www.bauschhealth.com/Portals/25/Pdf/PI/trulance-pi.pdf. Accessed June 8, 2026.

Tudorza® (aclidinium bromide inhalation powder) [prescribing information]. St. Louis, MO. Forest Pharmaceuticals, Inc. April 2019. https://www.tudorza.com/pdf/tudorza-pressair-prescribing-information.pdf. Accessed June 8, 2026.

Twyneo® (tretinoin and benzoyl peroxide) [Prescribing Information]. Fort Worth, TX: Galderma Laboratories, L.P.; July 2021. https://www.twyneo.com/hcp/safety/. Accessed June 8, 2026.

Uceris® (budesonide) [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals, LLC; April 2020. Available from: https://shared.salix.com/shared/pi/uceris-pi.pdf. Accessed June 8, 2026.

Uloric® (allopurinol) [prescribing information]. Lake County, IL: Takeda Pharmaceuticals America, Inc.; February 2019. Available from: https://general.takedapharm.com/ULORICPI. Accessed June 8, 2026.

Ultracet® (tramadol hydrochloride and acetaminophen) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. October 2019. http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/ULTRACET-pi.pdf Accessed June 8, 2026.

Ultram® (tramadol hydrochloride) [prescribing information]. Raritan, NJ: Ortho-McNeil Pharmaceutical, Inc. August 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021692s015lbl.pdf Accessed June 8, 2026.

Ultravate® (halobetasol propionate) [prescribing information]. Gurgaon, India: Ranbaxy Laboratories Inc., November 2015. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208183s000lbl.pdf Accessed June 8, 2026.

Uroxatral® (alfuzosin) [prescribing information]. St. Michael, Barbados: Concordia Pharmaceuticals Inc; May 2020. Accessed June 8, 2026.

US Food and Drug Administration (FDA): FDA Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines; requires label changes. US Food and Drug Administration (FDA). Silver Spring, MD. 2016. Available at: https://www.fda.gov/Drugs/DrugSafety/ucm489676.htm. Accessed June 8, 2026.

Vagifem (estradiol vaginal tablets) [prescribing information]. Novo Nordisk Inc. November 2009. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020908s013lbl.pdf. Accessed June 8, 2026.

VALCYTE® [prescribing information]. South San Francisco, CA: Genentech USA, Inc. Available at: VALCYTE Prescribing Information. Accessed June 8, 2026.

Valium® (diazepam) [prescribing information]. Nutley, NJ: Roche Laboratories Inc.; 2017. Accessed June 8, 2026.

Valtrex® (valacyclovir hydrochloride) [prescribing information]. Philadelphia, PA: GlaxoSmithKline LLC; 2013. Accessed June 8, 2026.

Vandazole (metronidazole) [prescribing information]. Maple Grove, MN: Upsher-Smith Laboratories, LLC. February 2021. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=27d71471-8f89-4a1e-8c55-020a58961454. Accessed June 8, 2026.

Vanos® (fluocinonide) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017. Accessed June 8, 2026.

Vascepa® (icosapent ethyl) [prescribing information]. Bridgewater, NJ: Amarin Pharma, Inc. September 2021. Available at: Vascepa-PI.pdf. Accessed June 8, 2026.

Vasotec® (enalapril) [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017. Accessed June 8, 2026.

Vecamyl™ (mecamylamine) [prescribing information]. Manchester, MO: Manchester Pharmaceuticals; 2015. Accessed June 8, 2026.

Velphoro (sucroferric oxyhydroxide) [prescribing information]. Waltham, MA: Fresenius Medical Care North America. September 2024. Available at: DailyMed - VELPHORO- sucroferric oxyhydroxide tablet, chewable. Accessed June 8, 2026.

Veltin® (clindamycin phosphate and tretinoin) [prescribing information]. West Chester, PA: Aqua Pharmaceuticals; 2016. Accessed June 8, 2026.

Vemlidy (tenofovir alafenamide) [prescribing information]. Foster City, CA: Gilead Sciences, Inc. July 2025. Available at: DailyMed - VEMLIDY- tenofovir alafenamide tablet. Accessed June 8, 2026.

Ventolin® (albuterol) [prescribing information]. Philadelphia, PA: GlaxoSmithKline LLC; February 2021. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Ventolin_HFA/pdf/VENTOLIN-HFA-PI-PIL.PDF Accessed June 8, 2026.

Verdeso® (desonide) [prescribing information]. West Chester, PA: Aqua Pharmaceuticals; April 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021978s015lbl.pdf. Accessed June 8, 2026.

Verelan® (verapamil) [prescribing information]. Gainesville, GA: Recro Gainesville LLC; October 2019. Accessed June 8, 2026.

Vesicare/Vesciare LS (solifenacin succinate) [prescribing information]. Astellas Pharma Technologies, Inc. June 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021518s016lbl.pdf. Accessed June 8, 2026.

Vevye® () [prescribing information]. Nashville, TN: Harrow Eye, LLC. September 2023. Available at: https://www.vevye.com/prescribinginformation.pdf. Accessed June 8, 2026.

Viagra (sildenafil) [prescribing information]. New York, NY: Pfizer Labs; December 2017. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=display. Accessed June 8, 2026.

Viberzi™ (eluxadoline) [prescribing information]. Parsippany, NJ: Allergan, Inc; June 2020. https://www.allergan.com/assets/pdf/viberzi_pi Accessed June 8, 2026.

Viibryd® (vilazodone hydrochloride) [prescribing information]. Parsippany, NJ: Allergan, Inc; January 2020. https://www.allergan.com/assets/pdf/viibryd_pi Accessed June 8, 2026.

Vijoice® (alpelisib) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; April 2022. Available from: https://www.novartis.com/us-en/sites/novartis_us/files/vijoice.pdf. Accessed June 8, 2026.

Viokace® (pancrelipase) [prescribing information]. Irvine, CA: Allergan USA, Inc. March 2020. Available at: https://www.allergan.com/assets/pdf/viokace_pi. Accessed June 8, 2026.

Vivlodex™ (meloxicam) [prescribing information]. Wayne, PA: Egalet US Inc. April 2019. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=11771dcf-0803-4de9-a2fe-73edec256209&type=display. Accessed June 8, 2026.

Vtama® (tapinarof) [prescribing information]. Long Beach, CA: Dermavant Sciences Inc. May 2025. Available from: https://www.vtama.com/hcp/PI/. Accessed June 8, 2026.

Vusion® (miconazole nitrate, zinc oxide, white petrolatum) [prescribing information]. Newtown,PA: Prestium Pharma, Inc.; May 2018. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021026s013lbl.pdf. Accessed June 8, 2026.

Vybrique (sildenafil) [package insert]. Parsippany, NJ. IBSA Pharma Inc., December 2025. Available from: https://www.drugs.com/pro/vybrique.html. Accessed June 8, 2026.

Vytorin® (ezetimibe and simvastatin) [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; October 2019. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021687s062lbl.pdf. Accessed June 8, 2026.

Vyvanse® (lisdexamfetamine dimesylate) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America, Inc. October 2023. Available from: https://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf. Accessed June 8, 2026.

Vyzulta™ (latanoprostene bunod) [prescribing information]. Bridgwater, NJ. Valeant Pharmaceuticals North America LLC. May 2019. https://www.bausch.com/Portals/69/-/m/BL/United%20States/USFiles/Package%20Inserts/Pharma/vyzulta-prescribing-information.pdf Accessed June 8, 2026.

Welchol® (colesevelam hydrochloride) [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc; July 2020. Available from: https://daiichisankyo.us/prescribing-information-portlet/getDocument?product=WC&inline=true. Accessed June 8, 2026.

Winlevi (clascoterone) [prescribing information]. Cassiopea, Inc; August 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf. Accessed June 8, 2026.

Xanax® (alprazolam) [prescribing information]. Kalamazoo, MI: Pharmacia and Upjohn Company LLC; 2017. http://labeling.pfizer.com/ShowLabeling.aspx?id=547 Accessed June 8, 2026.

Xatmep (methotrexate) solution [Package Insert]. Woburn, MA: Azurity Pharmaceuticals, Inc. Available at: DailyMed - XATMEP- methotrexate solution. Accessed June 8, 2026.

Xcopri® (cenobamate) [prescribing information]. Paramus, NJ: SK Life Science, Inc.; August 2020. Available from: www.xcopri.com/wp-content/uploads/2020/04/PI-and-Med-Guide.pdf. Accessed June 8, 2026.

Xelpros® (latanoprost) [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc. December 2020. Available at: https://xelpros.com/pdf/XelprosPI.pdf. Accessed June 8, 2026.

Xelstrym™ (dextroamphetamine) [prescribing information]. Miami, FL: Noven Pharmaceuticals; November 2022. Available from: https://www.xelstrym.com/. Accessed June 8, 2026.

Xepi™ (ozenoxacin) [prescribing information]. Wayne, PA. Cutanea Life Sciences, Inc. January 2020. Available at: https://www.xepicream.com/resources/full-prescribing-information. Accessed June 8, 2026.

Xerese® (acyclovir and hydrocortisone) [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC; August 2020. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3b6ac164-0f1e-4f36-94a1-1fdb07d710f5. Accessed June 8, 2026.

Ximino® (minocycline hydrochloride extended release) [package insert]. Jacksonville,FL: Ranbaxy Laboratories Inc; November 2020. http://www.ximinorx.com/pdf/ximino-er-caps-full-prescribing-information.pdf Accessed June 8, 2026.

Xolegel® (ketoconazole) [prescribing information]. West Chester, PA: Aqua Pharmaceuticals; 2015. Accessed June 8, 2026.

Xopenex® (levalbuterol) [prescribing information]. Lake Forest, IL: Akorn, Inc.; 2015. Accessed June 8, 2026.

Xphozah® (tenapanor) [prescribing information]. Waltham, MA: Ardelyx, Inc. October 2023. Available at: https://ardelyx.com/XPHOZAH-Prescribing-Information.pdf. Accessed June 8, 2026.

Xromi (hydroxyurea solution) [prescribing information]. January 2025. Available at: DailyMed - XROMI- hydroxyurea solution. Accessed June 8, 2026.

Xultophy® (insulin degludec and liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk; November 2019. https://www.novo-pi.com/xultophy10036.pdf Accessed June 8, 2026.

Yasmin (drospirenone and ethinyl estradiol) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc. May 2023. Available at: DailyMed - YASMIN- drospirenone and ethinyl estradiol kit. Accessed June 8, 2026.

Yaz (drospirenone and ethinyl estradiol) [prescribing information] Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc. May 2025. Available at: DailyMed - YAZ- drospirenone and ethinyl estradiol kit. Accessed June 8, 2026.

Yupelri™ (revenfenacin) [prescribing information]. Morgantown, WV: Mylan Specialty L.P. May 2019. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6dfebf04-7c90-436a-9b16-750d3c1ee0a6&type=display. Accessed June 8, 2026.

Zanaflex® (tizanidine hydrochloride) [prescribing information]. Ardsley, NY: Acorda Therapeutics, Inc.; 2017. Accessed June 8, 2026.

Zelnorm™ (tegaserod) [prescribing information]. Germany: Sloan Pharma. July 2019. Available from: https://www.myzelnorm.com/assets/pdfs/PM-000413_ZELNORM_PI-MG_160x850mm_v6FNL_ND.pdf. Accessed June 8, 2026.

Zenzedi® (dextroamphetamine sulfate) [prescribing information]. Atlanta GA: Arbor Pharmaceuticals, LLC; January 2019. Available from: https://www.zenzedi.com/docs/Zenzedi_Prescribing_Information_and_Medication_Guide.pdf. Accessed June 8, 2026.

Zerviate™ (cetirizine ophthalmic solution) [prescribing information]. Forth Worth, TX: Eyevance Pharmaceuticals, LLC.; February 2020. Available from: https://myzerviate.com/files/Zerviate_PI.pdf. Accessed June 8, 2026.

Zestril® (lisinopril) [prescribing information], Wilmington, DE; July 2017. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019777s076lbl.pdf. Accessed June 8, 2026.

Zetia® (ezetimibe) [prescribing information]. Whitehouse Station, NJ: Merck & Co., INC; August 2013. https://www.merck.com/product/usa/pi_circulars/z/zetia/zetia_pi.pdf. Accessed June 8, 2026.

Zilxi™ (minocycline) [prescribing information]. Bridgewater, NJ: Foamix Pharmaceuticals Inc.; May 2020. Available from: https://www.zilxihcp.com/downloads/zilxi-prescribing-information.pdf. Accessed June 8, 2026.

Zioptan® (tafluprost) [prescribing information]. Lake Forest, IL: Akorn, Inc.; November 2018. http://www.akorn.com/documents/catalog/package_inserts/17478-609-30.pdf Accessed June 8, 2026.

Zipsor® (diclofenac) [prescribing information]. Newark, CA: Depomed, Inc.; May 2016. Available from: https://www.zipsor.com/pdf/prescribing-information.pdf. Accessed June 8, 2026.

ZITUVIMET XR (sitagliptin and metformin hydrochloride) [prescribing information]. Pennington, NJ: Zydus Pharmaceuticals (USA) Inc. July 2024. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216778s000lbl.pdf. Accessed June 8, 2026.

Zituvio® (sitagliptin) [prescribing information]. Pennington, NJ: Zydus Pharmaceuticals (USA) Inc. October 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211566s000lbl.pdf. Accessed June 8, 2026.

Zocor® (simvastatin) [prescribing information]. Jersey City, NJ: Organon & Co.; June 2021. Available from: https://www.organon.com/product/usa/pi_circulars/z/zocor/zocor_pi.pdf. Accessed June 8, 2026.

Zoloft® (sertraline hydrochloride) [prescribing information]. Belmont, WA: Roerig; April 2019. http://labeling.pfizer.com/ShowLabeling.aspx?id=517#page=1 Accessed June 8, 2026.

Zonisade™ (zonisamide oral suspension) [prescribing information]. Wilmington, MA: Azurity Pharmaceuticals. July 2022. Available from: https://zonisade.com/wp-content/uploads/2022/09/22-2001-32115_Zonisade_PI_Proof-1_R10_Final.pdf. Accessed June 8, 2026.

Zoryve™ (roflumilast) cream [prescribing information]. Westlake, CA: Arcutis Biotherapeutics, Inc. July 2024. Available from: https://www.arcutis.com/wp-content/uploads/USPI-roflumilast-cream-FDAapproved-V1-29Jul2022.pdf. Accessed June 8, 2026.

Zoryve™ (roflumilast) foam [prescribing information]. Westlake, CA: Arcutis Biotherapeutics, Inc. May 2025. Available from: https://www.arcutis.com/wp-content/uploads/zoryve-foam-pi-hcp.pdf. Accessed June 8, 2026.

Ztlido™ (lidocaine topical system) [prescribing information]. San Diego, CA. Scilex Pharmaceuticals Inc. November 2018. Available at: https://www.ztlido.com/sites/default/files/pdfs/ZTlido-LABEL.pdf. Accessed June 8, 2026.

Zunveyl (benzgalantamine) [prescribing information]. Grapevine, TX: Alpha Cognition, Inc. February 2025. Available at: DailyMed - ZUNVEYL- benzgalantamine tablet, delayed release. Accessed June 8, 2026.

Zybic™ (meloxicam) [prescribing information]. Birmingham, AL. Redmont Pharmaceuticals, LLC; 2024. Available from: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=a1c2d65f-ebb1-48bf-8fa1-c216f7d570ec. Accessed June 8, 2026.

Zyflo® (zileuton) [prescribing information]. Cary, NC: Chiesi USA, Inc.; December 2018. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022052s014lbl.pdf. Accessed June 8, 2026.

Zypitamag® (pitavastatin) [prescribing information]. Pennington, NJ: Zydus Pharmaceuticals. June 2020. Available from: https://www.zypitamag.com/docs/prescribing_information.pdf?v=20200827075654. Accessed June 8, 2026.

PolicyVersionNumber: 38

PTApprovalDate: 6/11/2026

NextReviewDate: 6/10/2027

CrossReferences:

Rx.01.33 Off-Label Use

Rx.01.76 Quantity Level Limits for Pharmaceuticals Covered Under the Prescription Drug Benefit

ApplicableDrugs:

Refer to table above.

NotificationDate: 9/1/2026

NotificationDesc:

Annual policy review - Add Arynta, brivaracetam, Vybrique, Orudis, Sdamlo, Zybic, beclomethasone inhaler, Ontralfy, tizanidine 8mg capsule, halobetasol lotion 0.05% as target drugs

Update dry eye disease (Tryvaya, Vevye, Tryptr), skeletal muscle relaxants and meloxicam suspension criteria

Remove Desoxyn, Zyloprim, ApexiCon E, Pexeva, Rythmol SR, Osmoprep, Altabax, Tekturna HCT, Patanase, Kombiglyze XR, diclofenac [Zorvolex], Seebri, Loprox, ezetimibe-rosuvastatin [Roszet], Lonhala, Benzhydrocodone-APAP [Apadaz], Airduo, Armonair, Proair Digihaler, Monurol, Nulytely, Vibramycin

ProductName: N/A

GenericName: N/A

Pharmacy Policy System: NotificationsList

Prior Authorization Requirement for Select Drugs

WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY