martes, 2 de mayo de 2017

Drug Safety and Availability > Medication Guides

Drug Safety and Availability > Medication Guides

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The FDA Medication Guides page  has been updated to include:
Drug Safety and Availability > Medication Guides



  • Abilify (aripiprazole) [8/2016 version]  
  • Abilify Maintena (aripiprazole) [1/2016 version]
  • Absorica (isotrentinoin) [2014 version]
  • Abstral (fentanyl) [2016 version]
  • Aciphex (rabeprazole sodium) [4/2016 version]
  • Aciphex DR (rabeprazole sodium) [4/2016 version]
  • Accutane (isotretinoin) [2010 version]
  • Actemra (tocilizumab) [2014 version] 
  • Actiq (fentanyl citrate) [2016 version]
  • Actonel (risedronate sodium) [2015 version]
  • Actonel with Calcium (risedronate sodium and calcium carbonate) [2015 version]
  • Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2014 version] 
  • Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2016 version]
  • Actos (pioglitazone hydrchloride) [2016 version]
  • Adasuve (loxapine) [2016 version]
  • Adderall (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets) [2015 version]
  • Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate) [2015 version]
  • Addyi (flibanserin) [2015 version]
  • Adempas (riociguat) [2017 version]
  • Adlyxin (lixisenatide) {2016 version]
  • Advair Diskus (fluticasone propionate and salmeterol xinafoate) [4/2016 version]
  • Advair HFA (fluticasone propionate and salmeterol xinafoate) [2/2017 version]
  • Afrezza (insulin human) [2015 version]
  • Ambien (zolpidem tartrate) [2014 version]
  • Ambien CR (zolpidem tartrate) [2014 version]
  • Amevive* (alefacept) [2012 version]
  • Amjevita (adalimumab-atto) [9/2016 version]  
  • Ampyra (dalfampridine) [2016 version]  
  • Anafranil (clomipramine hydrochloride) [2014 version]
  • Anaprox (naproxen sodium) [8/2016 version]
  • Androgel (1%) (testosterone) [2014 version] 
  • Androgel (1.62%) (testosterone) [2015 version]
  • Anoro Ellipta (Umeclidinium; Vilanterol) [3/2017 version]
  • Ansaid (flurbiprofen) [5/2016 version]
  • Aplenzin (bupropion hydrobromide [2016 version]
  • Aptryxol( desvenlafaxine ) extended Release Tablets  [2017 version]
  • Aranesp* (darbepoetin alfa) [4/2017 version)
  • Arcapta (indacaterol maleate) [2012 version]
  • Aristada (aripiprazole lauroxil) [10/2015 version]
  • Arthrotec (diclofenac sodium) [5/2016 version]
  • Arymo ER (morphine sulfate)  [2017 version]
  • Astagraf XL (tacrolimus) [2014 version]
  • Atelvia (risedronate sodium) [2015 version]
  • Ativan (lorazepam) [2016 version]
  • Aubagio (teriflunomide) [2016 version]
  • Austedo (deutetrabenazine ) [4/2017 version] the word new in a red box
  • Avandamet (metformin hydrochloride and rosiglitazone maleate) [4/2017 version]
  • Avandaryl (glimepiride and rosiglitazone maleate) [3/2015 version]
  • Avandia (rosiglitazone maleate) [5/2014 version]
  • Aveed (testosterone undecanoate) [5/2015 version]
  • Avelox (moxifloxacin) [7/2016 version] 
  • Avinza (morphine sulfate) [2014 version]
  • Avonex(interferon beta-1a) [2014 version]
  • Axiron (testosterone) [2017 version]
  • Banzel (rufinamide) [2015 version]
  • Bavencio (avelumab) [3/2017 version]
  • Belbuca (buprenorphine) [12/2016 version]
  • Belsomra  (suvorexant) [2014 version]
  • Benlysta (belimumab) [2016 version] 
  • Betaseron*(interferon beta-1b) [2016 version]
  • Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) [4/2016 version]
  • Binosto (alendronate sodium) [2/2015 version]
  • Blincyto (blinatumomab) injection [8/2016 version] 
  • Boniva (ibandronate sodium) Injection [2016 version]
  • Boniva (ibandronate sodium) Tablets [2016  version]
  • Botox(onabotulinumtoxinA) [1/2016 version]
  • Breo Ellipta (fluticasone furoate and vilanterol) [2015 version]
  • Brilinta (ticagrelor) [9/2016 version]
  • Brintellix (vortioxetine) [2014 version] 
  • Brisdelle (paroxetine) [2016 version]
  • Briviact ((brivaracetam) [2/2016 version]
  • Brovana (arformoterol tartrate) [2014 version]
  • Bunavail (Buprenorphine and naloxone) Buccal Film (2016)
  • Butrans (buprenorphine) [2016 version] 
  • Bydureon (exenatide) [32015 version]
  • Byetta (exenatide) [2/2015 version]
  • Cambia (diclofenac) [3/2017 version]
  • Caprelsa (vandetanib) [3/2014 version]
  • Carbatrol (carbamazepine) [2013 version]
  • Cataflam (diclofenac potassium) [5/2016 version]
  • Celebrex (celecoxib) [5/2016 version]
  • Celexa (citalopram hydrobromide) [2017version]
  • Cellcept (mycophenolate mofetil) [2013 version] 
  • Celontin (methsuximide) [2010 version]
  • Cerdelga (eliglustat) [2014 version]
  • Chantix (varenicline tartrate) [2016 version]
  • Cimzia* (certolizumab pegol) [2016 version]
  • Cipro (ciprofloxacin) [2016 version]
  • Clinoril (sulindac) [2010 version]
  • Codeine Sulfate oral solution [2016 version]
  • Codeine Sulfate tablets [2016 version]
  • Colcrys (colchicine) [2012 version]
  • Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
  • Concerta (methylphenidate hydrochloride) [2013 version]
  • Contrave(naltrexone HCl and bupropion HCl) ER [9/2016 version]
  • Copegus (ribavirin) [2015 version]
  • Cordarone (amiodarone hydrochloride) [3/2015 version]
  • Corlanor (ivabradine) [2017 version]
  • Cosentyx (secukinumab) [2015 version]
  • Coumadin (warfarin sodium) [2016 version]
  • Creon (pancrelipase) [2012 version]
  • Cymbalta (duloxetine hydrochloride) [2017 version)]
  • Daliresp (roflumilast) [2015 version]
  • Dalmane (flurazepam hydrochloride) [2009 version]
  • Darvocet (acetaminophen and propoxyphene napsylate) [2009 version]
  • Darvon (propoxyphene hydrochloride) [2009 version]
  • Daypro (oxaprozin potassium) [5/2016 version]
  • Daypro Alta (oxaprozin potassium) [5/2016 version]
  • Daytrana (methylphenidate) [2017 version] 
  • Depakene (valproic acid) [3/2017 version] 
  • Depakote ER(divalproex sodium) [3/2017 version]
  • Desoxyn (methamphetamine hydrochloride) [2015 version]
  • Desvenlafaxine Extended Release Tablet(desvenlafaxine fumarate) [2017version] 
  • Dexedrine (dextroamphetamine sulfate) [2013 version]
  • Dexilant (dexlansoprazole) [2016 version]
  • Dilantin (phenytoin) Chewable/ER [2015 version]
  • Dilantin-125 (phenytoin) [2016 version]
  • Dolophine (methadone hydrochloride) [2016 version]
  • Doral (quazepam) [2016 version]
  • Duetact (glimepiride and pioglitazone) [3/2015 version]
  • Duexis (ibuprofen and famotidine) [5/2016 version]
  • Dulera (mometasone furoate and formoterol fumarate) [4/2015 version]
  • Duragesic (fentanyl) [2016 version]
  • Dyanavel XR (amphetamine) [2017 version]
  • Dysport* (abobotulinumtoxinA) [2016 version]
  • EC-Naprosyn (naproxen) [8/2016 version]
  • Edluar (zolpidem tartrate) [2013 version]
  • Effexor (venlafaxine hydrochloride) [2012 version]
  • Effexor XR (venlafaxine hydrochloride) [1/2017 version
  • Effient (prasugrel) [1/2016 version]
  • Elidel Cream (pimecrolimus) [3/2014 version]
  • Eliquis (apixaban) [6/2015 version]
  • Embeda (morphine sulfate and naltrexone hydrochloride) [2014 version]
  • Emsam (selegeline transdermal system) [2007 version]
  • Enbrel* (etanercept) [2013 version]
  • Entyvio (vedolizumab) [2014 version]  
  • Epogen* (epoetin alfa) [2012 version] 
  • Epzicom (abacavir sulfate and lamivudine) [3/2017 version]
  • Equetro (carbamazepine) [9/2016 version]
  • Erivedge (vismodegib) [2016 version] 
  • Estazolam [2008 version]
  • Evista (raloxifene hydrochloride) [2007 version]
  • Exalgo (hydromorphone hydrochloride) [2014 version]
  • Extavia (interferon beta-1b) [2016 version]
  • Extraneal (icodextrin) [2010 version]
  • Exubera (insulin recombinant human) [2008 version]
  • Factive (gemifloxacin) [2016 version]
  • Farxiga (dapagliflozin) [8/2016 version]
  • Farydak (panobinostat) [2/2015 version]
  • Felbatol (felbamate) [2011 version]
  • Feldene (piroxicam) [5/2016 version]
  • Fentora (fentanyl citrate) [12/2016 version]
  • Ferriprox (deferiprone) [2012 version]
  • Fetzima (levomilnacipran) [2017 version]
  • FIORINAL with CODEINE (Butalbital, Aspirin, Caffeine, and Codeine Phosphate) [12/2016 version]
  • Flector (diclofenac epolamine) [5/2016 version]
  • Floxin (ofloxacin) [2011 version]
  • Fluoxetine (Fluoxetine) [2017 version]
  • Fluvoxamine (Fluvoxamine Maleate) [2014 version]
  • Focalin (dexmethylphenidate hydrochloride) [2017 version]
  • Focalin XR (dexmethylphenidate hydrochloride) [2017 version]
  • Foradil Aerolizer (formoterol fumarate inhalation powder) [2012 version]
  • Foradil Certihaler (formoterol fumarate inhalation powder) [2010 version]
  • Forfivo XL (bupropion hydrochloride) [8/2016 version]
  • Forteo (teriparatide) [2013 version]
  • Fortesta (testosterone) [5/2015 version]
  • Fosamax (alendronate sodium) [2013 version]
  • Fosamax Plus D (alendronate sodium and cholecalciferol) [2013 version]
  • Fosrenol (lanthanum carbonate) [9/2014 version]
  • Fycompa (perampanel) [4/2016 version] 
  • Gabitril (tiagabine) [11/2015 version]
  • Gattex (teduglutide [rDNA origin]) [2012 version] 
  • Gilenya (fingolimid) [2/2016 version]
  • Glyxambi (empagliflozin and linagliptin) Tablets [3/2017 version]
  • GoLytely (polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate anhydrous) [2013 version]
  • Gralise (gabapentin) [2012 version]
  • Halcion (triazolam) [2016 version]
  • HalfLytely and Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, and sodium chloride) [2010 version]
  • Horizant (gabapentin enacarbil) [2013 version] 
  • H.P. Acthar Gel (repository corticotropin) [2010 version]
  • Humira (adalimumab) [4/2017 version] Updated
  • Hycodan ( hydrocodone bitartrate and homatropine methylbromide) [2017 version]
  • Hydromorphone Hydrochloride ER [2014 version]
  • Hysingla ER (Hydrocodone, Bitartrate) [2016 version]
  • Iclusig (ponatinib) [2016 version]
  • Ilaris* (canakinumab) [7/2016 version]
  • Imfinzi (durvalumab) [4/2017 version] the word new in a red box
  • Impavido (miltefosine) [2014 version]
  • Incivek (telaprevir) [2013 version]
  • Indocin (indomethacin) [5/2016 version]
  • Indocin SR (indomethacin) [5/2016 version]
  • Inflectra (Infliximab-dyyb) [4/2016 version]
  • Infergen* (interferon alfacon-1) [2013 version]
  • Intermezzo (zolpidem tartrate) [2013 version]
  •  Intron A* (interferon alfa-2b) [4/2014 version]
  • Invirase (saquinavir mesylate) [12/2016 version] 
  • Invokamet (canagliflozin and metformin hydrochloride) [2017]  
  • Invokamet XR (canagliflozin and metformin hydrochloride extended-release) [2016 version]
  • Invokana (canagliflozin) [2016 version]
  • Janumet (metformin hydrochloride and sitagliptin phosphate) [2013 version]
  • Janumet XR (sitagliptin and metformin hydrochloride) [2014 version]
  • Januvia (sitagliptin phosphate) [2013 version]
  • Jentadueto (linagliptin and metformin hydrochloride) [3/2017 version]
  • Jentadueto XR (linagliptin and metformin hydrochloride) [7/2017 version] 
  • Juvisync (sitagliptin and simvastatin) [2014 version]
  • Juxtapid (lomitapide) [5/2016 version]   
  • Kadian (morphine sulfate) [12/2016 version]
  • Kalbitor(ecallantide) [3/2014 version]
  • Kaletra Capsules (lopinavir and ritonavir) [2013 version]
  • Kaletra Tablets and Oral Solution (lopinavir and ritonavir) [11/2016 version]  
  • Kazano (alogliptin and metformin hydrochloride) [4/2016 version] 
  • Keppra (levetiracetam) [4/2017 version]Updated
  • Keppra XR (levetiracetam) [4/2017 version Updated
  • Ketek (telithromycin) [2010 version]
  • Keytruda (pembrolizumab) [3/2017 version]
  • Khedezla (desvenlafaxine) [2016 version]
  • Klonopin (clonazepam) [2016 version] 
  • Kombiglyze XR (metformin hydrochloride and saxagliptin) [2/2017 version]  
  • Korlym (mifepristone) [2012 version]
  • Krystexxa* (pegloticase) [12/2014 version]
  • Kynamro (mipomersen sodium) [5/2016 version] 
  • Lacosamide Tablets (lacosamide) [4/2016 version]
  • Lacosamide Tablets CV (lacosamide) [4/2016 version]
  • Lacosamide Oral Solution (lacosamide) [3/2016 version]
  • Lamictal (lamotrigine) [2013 version] 
  • Lamictal XR (lamotrigine) [2013 version]
  • Lamisil (terbinafine hydrochloride) [8/2016 version]
  • Lariam (mefloquine hydrochloride) [2009 version]
  • Latuda (lurasidone hydrochloride) [2017 version]
  • Lazanda (fentanyl citrate) [2016 version]
  • Lemtrada (alemtuzumab) Injection [11/2014 version]
  • Letairis (ambrisentan) [10/2015 version] 
  • Levaquin (levofloxacin) [2016 version]
  • Lexapro (escitalopram oxalate) [2017 version]
  • Librax  ( chlordiazepoxide HCl and clidinium bromide ) [2017 version]
  • Librium(chlordiazepoxide) [2016 version]
  • Limbitrol (chlordiazepoxide and amitriptyline) [2016 version]
  • Lindane Lotion (lindane) [2007 version]
  • Lindane Shampoo (lindane) [2007 version]
  • Linzess (linaclotide) [3/2017 version]
  • Lotronex (alosetron hydrochloride) [/2016 version]
  • Lunesta (eszopiclone) [2014 version]
  • Luvox (fluvoxamine maleate) [2014 version] See: Fluvoxamine
  • Luvox CR (fluvoxamine maleate) [2014 version]
  • Lynparza (olaparib) [2014 version]
  • Lyrica (pregabalin) [2013 version]
  • Marplan (isocarboxazid) [2008 version]
  • Mekinist (trametinib) [2015 version]
  • Meridia (sibutramine hydrochloride) [2010 version]
  • Metadate CD (methylphenidate hydrochloride) [2014 version]
  • Methylin (methylphenidate)
  • Metoclopramide Oral Solution [2009 version]
  • Metozolv ODT (metoclopramide hydrochloride) [2011 version]
  • Mifeprex (mifepristone) [2016 version]
  • Mircera* (methoxy polyethylene glycol-epoetin beta) [4/2016 version]
  • Mitigare (Colchicine) [9/2014 version]
  • Mobic (meloxicam) [5/2016 version]
  • Morphabond (morphine sulfate)extended release tablets [12/2016]
  • Morphine Sulfate (morphine sulfate oral solution) [2011 version]
  • Motrin (ibuprofen) [2007 version]
  • Moviprep (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2013 version]
  • Moxifloxacin (moxifloxacin) [7/2016 version]
  • MS Contin (morphine sulfate) [2014 version] 
  • Multaq (dronedarone) [2014 version]
  • Myalept (Metreleptin) [2015 version]
  • Myfortic (mycophenolic acid) [2013 version]
  • Myobloc* (rimabotulinumtoxinB) [2009 version]
  • Mysoline (primidone) [2010 version]

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