sábado, 18 de mayo de 2013

Drug Safety and Availability > Medication Guides

Drug Safety and Availability > Medication Guides


Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:
  • certain information is necessary to prevent serious adverse effects
  • patient decision-making should be informed by information about a known serious side effect with a product, or
  • patient adherence to directions for the use of a product are essential to its effectiveness.
Please note: All links in the table below go to documents in PDF format.

    Medication Guides are available for these products:
*biologic or drug/biologic combination


  • Abilify (aripiprazole) [2012 version]  
  • Abilify Maintena (aripiprazole) [2013 version]
  • Absorica (isotrentinoin) [2012 version]
  • Abstral (fentanyl) [2011 version]
  • Aciphex (rabeprazole sodium) [2012 version]
  • Accutane (isotretinoin) [2010 version]
  • Actemra* (tocilizumab) [2013 version] 
  • Actiq (fentanyl citrate) [2011 version]
  • Actonel (risedronate sodium) [2013 version]
  • Actonel with Calcium (risedronate sodium and calcium carbonate) [2013 version]
  • Actoplus Met (metformin hydrochloride and pioglitazone hydrochloride) [2012 version] 
  • Actoplus Met XR (metformin hydrochloride and pioglitazone hydrochloride) [2011 version]
  • Actos (pioglitazone hydrchloride) [2011 version]
  • Adasuve (loxapine) [2012 version]
  • Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2013 version]
  • Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2011 version]
  • Advair HFA (fluticasone propionate and salmeterol xinafoate) [2012 version]
  • Ambien (zolpidem tartrate) [2013 version]
  • Ambien CR (zolpidem tartrate) [2013 version]
  • Amevive* (alefacept) [2012 version]
  • Ampyra (dalfampridine) [2013 version]  
  • Anafranil (clomipramine hydrochloride) [2012 version]
  • Anaprox (naproxen sodium) [2013 version]
  • Androgel (testosterone) [2012 version] 
  • Androgel (1.62%) (testosterone) [2012 version]
  • Ansaid (flurbiprofen) [2010 version]
  • Aplenzin (bupropion hydrobromide [2012 version]
  • Aranesp* (darbepoetin alfa) [2012 version)
  • Arcapta (indacaterol maleate) [2012 version]
  • Arthrotec (diclofenac sodium) [2013 version]
  • Atelvia (risedronate sodium) [2013 version]
  • Aubagio (teriflunomide) [2012 version]
  • Avandamet (metformin hydrochloride and rosiglitazone maleate) [2011 version]
  • Avandaryl (glimepiride and rosiglitazone maleate) [2011 version]
  • Avandia (rosiglitazone maleate) [2011 version]
  • Avelox (moxifloxacin) [2012 version] 
  • Avinza (morphine sulfate) [2013 version]
  • Avonex* (interferon beta-1a) [2012 version]
  • Axiron (testosterone) [2011 version]
  • Banzel (rufinamide) [2011 version]
  • Benlysta (belimumab) [2012 version] 
  • Betaseron*(interferon beta-1b) [2012 version]
  • Binosto (alendronate sodium) [2013 version]
  • Boniva (ibandronate sodium) Injection [2013 version]
  • Boniva (ibandronate sodium) Tablets [2013 version]
  • Botox* (onabotulinumtoxinA) [2013 version]
  • New! Breo Ellipta (fluticasone furoate and vilanterol) [2013 version]
  • Brilinta (ticagrelor) [2013 version]
  • Brovana (arformoterol tartrate) [2011 version]
  • Butrans (buprenorphine) [2012 version] 
  • Bydureon (exenatide) [2012 version]
  • Byetta (exenatide) [2011 version]
  • Cambia (diclofenac) [2009 version]
  • Caprelsa (vandetanib) [2012 version]
  • Carbatrol (carbamazepine) [2010 version]
  • Cataflam (diclofenac potassium) [2011 version]
  • Celebrex (celecoxib) [2011 version]
  • Celexa (citalopram hydrobromide) [2012 version]
  • Cellcept (mycophenolate mofetil) [2012 version] 
  • Celontin (methsuximide) [2010 version]
  • Chantix (varenicline tartrate) [2012 version]
  • Cimzia* (certolizumab pegol) [2012 version]
  • Cipro (ciprofloxacin) [2013 version]
  • Clinoril (sulindac) [2010 version]
  • Updated Codeine Sulfate oral solution [2013 version]
  • Colcrys (colchicine) [2011 version]
  • Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
  • Updated Concerta (methylphenidate hydrochloride) [2013 version]
  • Copegus (ribavirin) [2011 version]
  • Cordarone (amiodarone hydrochloride) [2011 version]
  • Coumadin (warfarin sodium) [2011 version]
  • Creon (pancrelipase) [2012 version]
  • Cymbalta (duloxetine hydrochloride) [2012 version)]
  • Daliresp (roflumilast) [2011 version]
  • Dalmane (flurazepam hydrochloride) [2009 version]
  • Darvocet (acetaminophen and propoxyphene napsylate) [2009 version]
  • Darvon (propoxyphene hydrochloride) [2009 version]
  • Daypro Alta (oxaprozin potassium) [2007 version]
  • Daytrana (methylphenidate) [2010 version]
  • Depakene (valproic acid) [2013 version]
  • Depakote (divalproex sodium) [2013 version]
  • Desoxyn (methamphetamine hydrochloride) [2007 version]
  • Dexedrine (dextroamphetamine sulfate) [2008 version]
  • Dexilant (dexlansoprazole) [2012 version]
  • Dilantin (phenytoin) [2011 version]
  • Dilantin-125 (phenytoin) [2013 version]
  • Dolophine (methadone hydrochloride) [2013 version]
  • Doral (quazepam) [2013 version]
  • Duetact (glimepiride and pioglitazone) [2011 version]
  • Duexis (ibuprofen and famotidine) [2011 version]
  • Dulera (mometasone furoate and formoterol fumarate) [2013 version]
  • Duragesic (fentanyl) [2012 version]
  • Dysport* (abobotulinumtoxinA) [2012 version]
  • EC-Naprosyn (naproxen) [2013 version]
  • Edluar (zolpidem tartrate) [2013 version]
  • Effexor (venlafaxine hydrochloride) [2012 version]
  • Effexor XR (venlafaxine hydrochloride) [2012 version]
  • Effient (prasugrel) [2012 version]
  • Elidel Cream (pimecrolimus) [2010 version]
  • Eliquis (apixaban) [2012 version]
  • Embeda (morphine sulfate and naltrexone hydrochloride) [2012 version]
  • Emsam (selegeline transdermal system) [2007 version]
  • Enbrel* (etanercept) [2012 version]
  • Epogen* (epoetin alfa) [2012 version] 
  • Epzicom (abacavir sulfate and lamivudine) [2012 version]
  • Equetro (carbamazepine) [2012 version]
  • Erivedge (vismodegib) [2012 version]
  • Evista (raloxifene hydrochloride) [2007 version]
  • Exalgo (hydromorphone hydrochloride) [2013 version]
  • Extavia* (interferon beta-1b) [2012 version]
  • Extraneal (icodextrin) [2010 version]
  • Exubera (insulin recombinant human) [2008 version]
  • Factive (gemifloxacin) [2011 version] 
  • Felbatol (felbamate) [2011 version]
  • Feldene (piroxicam) [2010 version]
  • Fentora (fentanyl citrate) [2013 version]
  • Ferriprox (deferiprone) [2012 version]
  • Flector (diclofenac epolamine) [2010 version]
  • Floxin (ofloxacin) [2011 version]
  • Focalin (dexmethylphenidate hydrochloride) [2012 version]
  • Focalin XR (dexmethylphenidate hydrochloride) [2012 version]
  • Foradil Aerolizer (formoterol fumarate inhalation powder) [2012 version]
  • Foradil Certihaler (formoterol fumarate inhalation powder) [2010 version]
  • Forfivo XL (bupropion hydrochloride) [2011 version]
  • Forteo (teriparatide) [2009 version]
  • Fortesta (testosterone) [2010 version]
  • Fosamax (alendronate sodium) [2013 version]
  • Fosamax Plus D (alendronate sodium and cholecalciferol) [2013 version]
  • Fosrenol (lanthanum carbonate) [2012 version]
  • Fycompa (perampanel) [2012 version] 
  • Gabitril (tiagabine) [2010 version]
  • Gattex (teduglutide [rDNA origin]) [2012 version] 
  • Gilenya (fingolimid) [2012 version]
  • Gralise (gabapentin) [2012 version]
  • Halcion (triazolam) [2008 version]
  • HalfLytely and Bisacodyl Bowel Prep Kit (bisacodyl, polyethylene glycol 3500, potassium chloride, sodium bicarbonate, sodium chloride) [2010 version]
  • Updated Horizant (gabapentin enacarbil) [2013 version] 
  • H.P. Acthar Gel (repository corticotropin) [2010 version]
  • Humira* (adalimumab) [2012 version]
  • Incivek (telaprevir) [2013 version]
  • Iclusig (ponatinib) [2012 version]
  • New! Ilaris* (canakinumab) [2013 version] 
  • Indocin (indomethacin) [2008 version]
  • Infergen* (interferon alfacon-1) [2010 version]
  • Intermezzo (zolpidem tartrate) [2013 version]
  • Intron A* (interferon alfa-2b) [2012 version]
  • Invirase (saquinavir mesylate) [2012 version] 
  • Invokana (canagliflozin) [2013 version]
  • Janumet (metformin hydrochloride and sitagliptin phosphate) [2013 version]
  • Janumet XR (sitagliptin and metformin hydrochloride) [2013 version]
  • Januvia (sitagliptin phosphate) [2013 version]
  • Juvisync (sitagliptin and simvastatin) [2013 version]
  • Juxtapid (lomitapide) [2012 version]  
  • Kadian (morphine sulfate) [2012 version]
  • Kalbitor* (ecallantide) [2009 version]
  • Kaletra Capsules (lopinavir and ritonavir) [2013 version]
  • Kaletra Tablets and Oral Solution (lopinavir and ritonavir) [2013 version]  
  • Kazano (alogliptin and metformin hydrochloride) [2013 version] 
  • Keppra (levetiracetam) [2011 version]
  • Keppra XR (levetiracetam) [2009 version]
  • Ketek (telithromycin) [2010 version]
  • Klonopin (clonazepam) [2010 version]
  • Kombiglyze XR (metformin hydrochloride and saxagliptin) [2012 version]  
  • Korlym (mifepristone) [2012 version]
  • Krystexxa* (pegloticase) [2012 version]
  • Kynamro (mipomersen sodium) [2013 version] 
  • Lamictal (lamotrigine) [2012 version] 
  • Lamictal XR (lamotrigine) [2012 version]
  • Lariam (mefloquine hydrochloride) [2009 version]
  • Lazanda (fentanyl citrate) [2011 version]
  • Letairis (ambrisentan) [2012 version] 
  • Levaquin (levofloxacin) [2011 version]
  • Lexapro (escitalopram oxalate) [2012 version]
  • Limbitrol (chlordiazepoxide and amitriptyline) [2007 version]
  • Lindane Lotion (lindane) [2007 version]
  • Lindane Shampoo (lindane) [2007 version]
  • Linzess (linaclotide) [2012 version]
  • Lotronex (alosetron hydrochloride) [2010 version]
  • Lunesta (eszopiclone) [2012 version]
  • Luvox (fluvoxamine maleate) [2012 version]
  • Luvox CR (fluvoxamine maleate) [2012 version]
  • Lyrica (pregabalin) [2012 version]
  • Marplan (isocarboxazid) [2008 version]
  • Meridia (sibutramine hydrochloride) [2010 version]
  • Metadate CD (methylphenidate hydrochloride) [2009 version]
  • Methylin (methylphenidate)
  • Metoclopramide Oral Solution [2009 version]
  • Metozolv ODT (metoclopramide hydrochloride) [2011 version]
  • Mifeprex (mifepristone) [2009 version]
  • Mircera* (methoxy polyethylene glycol-epoetin beta) [2007 version]
  • Mobic (meloxicam) [2011 version]
  • 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) [2012 version]
  • MS Contin (morphine sulfate) [2012 version] 


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