viernes, 5 de octubre de 2012

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]  
  • Absorica (isotrentinoin) [2012 version]
  • Abstral (fentanyl) [2011]
  • Accutane (isotretinoin) [2010 version]
  • Actemra* (tocilizumab) [2012 version] 
  • Actiq (fentanyl citrate) [2011 version]
  • Actonel (risedronate sodium) [2011 version]
  • Actonel with Calcium (risedronate sodium and calcium carbonate) [2011 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]
  • Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate) [2011 version]
  • Advair Diskus (fluticasone propionate and salmeterol xinafoate) [2011 version]
  • Advair HFA (fluticasone propionate and salmeterol xinafoate) [2011 version]
  • Ambien (zolpidem tartrate) [2010 version]
  • Ambien CR (zolpidem tartrate) [2010 version]
  • Amevive* (alefacept) [2012 version]
  • Ampyra (dalfampridine) [2012 version]  
  • Anafranil (clomipramine hydrochloride) [2007 version]
  • Anaprox (naproxen sodium) [2008 version]
  • Updated Androgel (testosterone) [2012 version] 
  • Androgel (1.62%) (testosterone) [2012 version]
  • Ansaid (flurbiprofen) [2010 version]
  • Aplenzin (bupropion hydrobromide [2012 version]
  • Aranesp* (darbepoetin alfa) [2012 version)
  • Updated Arcapta (indacaterol maleate) [2012 version]
  • Arthrotec (diclofenac sodium) [2010 version]
  • Atelvia (risedronate sodium) [2012 version]
  • New! 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) [2012 version]
  • Avonex* (interferon beta-1a) [2012 version]
  • Axiron (testosterone) [2011 version]
  • Banzel (rufinamide) [2011 version]
  • Benlysta (belimumab) [2012 version] 
  • Betaseron*(interferon beta-1b) [2009 version]
  • Binosto (alendronate sodium) [2012 version]
  • Boniva (ibandronate sodium) Injection [2011 version]
  • Boniva (ibandronate sodium) Tablets [2011 version]
  • Botox* (onabotulinumtoxinA) [2011 version]
  • Brilinta (ticagrelor) [2011 version]
  • Brovana (arformoterol tartrate) [2011 version]
  • Butrans (buprenorphine) [2012 version] 
  • Bydureon (exenatide) [2012 version]
  • Byetta (exenatide) [2011 version]
  • Cambia (diclofenac) [2009 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) [2011 version]
  • Cimzia* (certolizumab pegol) [2012 version]
  • Cipro (ciprofloxacin) [2011 version]
  • Clinoril (sulindac) [2010 version]
  • Codeine Sulfate oral solution [2012 version]
  • Colcrys (colchicine) [2011 version]
  • Combunox (oxycodone hydrochloride and ibuprofen) [2010 version]
  • Concerta (methylphenidate hydrochloride) [2010 version]
  • Copegus (ribavirin) [2011 version]
  • Cordarone (amiodarone hydrochloride) [2011 version]
  • Coumadin (warfarin sodium) [2011 version]
  • Creon (pancrelipase) [2011 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]
  • Desoxyn (methamphetamine hydrochloride) [2007 version]
  • Dexedrine (dextroamphetamine sulfate) [2008 version]
  • New! Dexilant (dexlansoprazole) [2012 version]
  • Dilantin (phenytoin) [2011 version]
  • Dilantin-125 (phenytoin) [2011 version]
  • Dolophine (methadone hydrochloride) [2012 version]
  • Doral (quazepam) [2007 version]
  • Duetact (glimepiride and pioglitazone) [2011 version]
  • Duexis (ibuprofen and famotidine) [2011 version]
  • Dulera (mometasone furoate and formoterol fumarate) [2012 version]
  • Duragesic (fentanyl) [2012 version]
  • Dysport* (abobotulinumtoxinA) [2012 version]
  • EC-Naprosyn (naproxen) [2008 version]
  • Edluar (zolpidem tartrate) [2009 version]
  • Effexor (venlafaxine hydrochloride) [2012 version]
  • Effexor XR (venlafaxine hydrochloride) [2012 version]
  • Effient (prasugrel) [2011 version]
  • Elidel Cream (pimecrolimus) [2010 version]
  • Embeda (morphine sulfate and naltrexone hydrochloride) [2012 version]
  • Emsam (selegeline transdermal system) [2007 version]
  • Enbrel* (etanercept) [2010 version]
  • Epogen* (epoetin alfa) [2012 version] 
  • Epzicom (abacavir sulfate and lamivudine) [2012 version]
  • Erivedge (vismodegib) [2012 version]
  • Evista (raloxifene hydrochloride) [2007 version]
  • Exalgo (hydromorphone hydrochloride) [2012 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) [2011 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]
  • Updated 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) [2012 version]
  • Fosamax Plus D (alendronate sodium and cholecalciferol) [2011 version]
  • Fosrenol (lanthanum carbonate) [2011 version]
  • Gabitril (tiagabine) [2010 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]
  • Horizant (gabapentin enacarbil) [2012 version] 
  • H.P. Acthar Gel (repository corticotropin) [2010 version]
  • Updated Humira* (adalimumab) [2012 version]
  • Incivek (telaprevir) [2012 version]
  • Indocin (indomethacin) [2008 version]
  • Infergen* (interferon alfacon-1) [2010 version]
  • Intermezzo (zolpidem tartrate) [2011 version]
  • Intron A* (interferon alfa-2b) [2012 version]
  • Invirase (saquinavir mesylate) [2012 version] 
  • Janumet (metformin hydrochloride and sitagliptin phosphate) [2012 version]
  • Janumet XR (sitagliptin and metformin hydrochloride) [2012 version]
  • Januvia (sitagliptin phosphate) [2012 version]
  • Updated Juvisync (sitagliptin and simvastatin) [2012 version]
  • Kadian (morphine sulfate) [2012 version]
  • Kalbitor* (ecallantide) [2009 version]
  • Kaletra Capsules (lopinavir and ritonavir) [2012 version]
  • Kaletra Tablets and Oral Solution (lopinavir and ritonavir) [2012 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]
  • 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) [2011 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) [2008 version]
  • Luvox (fluvoxamine maleate) [2011 version]
  • Luvox CR (fluvoxamine maleate) [2011 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) [2010 version]
  • Motrin (ibuprofen) [2007 version]
  • Moviprep (propylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) [2012 version]
  • MS Contin (morphine sulfate) [2012 version]
  • Multaq (dronedarone) [2012 version]
  • Myfortic (mycophenolic acid) [2012 version]
  • Myobloc* (rimabotulinumtoxinB) [2009 version]
  • Mysoline (primidone) [2010 version]
  • Nalfon (fenoprofen calcium) [2009 version]
  • Naprelan (naproxen sodium) [2011 version]
  • Naprosyn (naproxen) [2008 version]
  • Nardil (phenelzine sulfate) [2007 version]
  • Neurontin (gabapentin) [2011 version]
  • New! Nexium (esomeprazole magnesium) [2012 version] 
  • Nolvadex (tamoxifen) [2006 version]
  • Noroxin (norfloxacin) [2012 version]
  • Norpramin (desipramine hydrochloride) [2009 version]
  • Novantrone (mitoXantrone) [2012 version]
  • Nplate* (romiplostim) [2011 version]
  • Nucynta (tapentadol hydrochloride) [2010 version]
  • Nucynta ER (tapentadol) [2012 version]
  • Nulojix* (belatacept) [2011 version]
  • Nuvigil (armodafinil) [2010 version]
  • Oleptro (trazodone hydrochloride) [2010 version]
  • Omontys (peginesatide) [2012 version]
  • Onfi (clobazam) [2011 version]
  • Onglyza (saxagliptin hydrochloride) [2011 version]
  • Onsolis (fentanyl buccal soluble film) [2011 version]
  • Opana ER (oxymorphone hydrochloride) [2012 version]
  • Osmoprep (sodium phosphate dibasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
  • Oxycodone Hydrochloride Oral Solution [2012 version]
  • OxyContin (oxycodone hydrochloride) [2012 version]
  • Pacerone (amiodarone hydrochloride) [2008 version]
  • Palladone (hydromorphone hydrochloride) [2004 version]
  • Pamelor (nortriptyline hydrochloride) [2007 version]
  • Pancreaze (pancrelipase) [2010 version]
  • Parnate (tranylcypromine sulfate) [2008 version]
  • Paxil (paroxetine hydrochloride) [2011 version]
  • Paxil CR (paroxetine hydrochloride) [2011 version]
  • Peganone (ethotoin) [2010 version]
  • Pegasys* (peginterferon alfa-2a) [2011 version]
  • Pegintron* (peginterferon alfa-2b) [2012 version] 
  • PegIntron*/Rebetol Combo Pack (peginterferon alfa-2b and ribavirin) [2008 version]
  • Pennsaid (diclofenac sodium) [2010 version]
  • Perforomist (formoterol fumarate) [2012 version]
  • Pertzye (pancrelipase) [2012 version]
  • Pexeva (paroxetine mesylate) [2011 version]
  • Plavix (clopidogrel bisulfate) [2011 version]
  • Ponstel (mefenamic acid) [2008 version]
  • Potiga (ezogabine) [2012 version]
  • Pradaxa (dabigatran etexilate mesylate) [2012 version] 
  • Prepopik (sodium picosulfate, magnesium oxide and citric acid) [2012 version]
  • New! Prevacid (lansoprazole [2012 version]
  • Prevacid NapraPac (lansoprazole and naproxen) [2009 version]
  • New! Prilosec (omeprazole [2012 version]
  • Pristiq (desvenlafaxine succinate) [2011 version]
  • Procrit* (epoetin alfa) [2012 version]
  • Updated Prolia* (denosumab) [2012 version] 
  • Propylthiouracil [2010 version]
  • Promacta (eltrombopag) [2011 version]
  • Propulsid (cisapride) [2006 version]
  • Proquin XR (ciprofloxacin hydrochloride) [2011 version]
  • Protopic Ointment (tacrolimus) [2011 version]
  • Provigil (modafinil) [2010 version]
  • Prozac (fluoxetine hydrochloride) [2011 version]
  • Qsymia (phentermine and topiramate) [2012 version]
  • Qualaquin (quinine sulfate) [2011 version]
  • New! Quillivant XR (methylphenidate) [2012 version] 
  • Rapamune (sirolimus) [2010 version]
  • Rebetol (ribavirin) [2010 version]
  • Rebif* (interferon beta-1a) [2002 version]
  • Reclast (zoledronic acid) [2011 version]
  • Reglan (metoclopramide hydrochloride) injection [2009 version] 
  • Reglan (metoclopramide hydrochloride) tablets [2011 version]
  • Reglan ODT (metoclopramide hydrochloride) [2011 version]
  • Remeron (mirtazapine) [2011 version]
  • Remeron SolTabs (mirtazapine) [2011 version]
  • Remicade* (infliximab) [2011 version]
  • Restoril (temazepam) [2010 version]
  • Revlimid (lenalidomide) [2012 version]  
  • Ribasphere (ribavirin) [2008 version]
  • Ritalin (methylphenidate hydrochloride) [2010 version]
  • Ritalin LA (methylphenidate hydrochloride) [2010 version]
  • Ritalin-SR (methylphenidate hydrochloride) [2010 version]
  • Rituxan* (rituximab) [2012 version]
  • Roferon-A* (interferon alfa-2a recombinant) [2008 version]
  • Rozerem (ramelteon) [2010 version]
  • Sabril (vigabatrin) [2010 version]
  • Samsca (tolvaptan) [2012 version]
  • Sarafem (fluoxetine hydrochloride) [2009 version]
  • Savella (milnacipran hydrochloride) [2010 version]
  • Selzentry (maraviroc) [2012 version]
  • Serevent Diskus (salmeterol xinafoate) [2010 version]
  • Seroquel (quetiapine fumarate) [2011 version] 
  • Seroquel XR (quetiapine fumarate) [2011 version] 
  • Silenor (doxepin) [2010 version]
  • Simponi* (golimumab) [2010 version]
  • Sinequan (doxepin hydrochloride) [2007 version]
  • Soliris* (eculizumab) [2009 version]
  • Soltamox (tamoxifen citrate) [2005 version]
  • Soriatane (acitretin) [2011 version]
  • Sotret (isotretinoin) [2006 version]
  • Stelara* (ustekinumab) [2012 version]
  • Strattera (atomoxetine hydrochloride) [2012 version] 
  • Suboxone (buprenorphine and naloxone) [2012 version] 
  • Subsys (fentanyl) [2012 version]
  • Subutex (buprenorphine) [2011 version]
  • Suprep (sodium sulfate, potassium sulfate and magnesium sulfate) [2010 version]
  • Sutent (sunitimib malate) [2012 version]
  • Sylatron (peginterferon alfa-2b) [2012 version]
  • Symbicort (budesonide and formoterol fumarate dihydrate) [2010 version]
  • Symbyax (fluoxetine hydrochloride and olanzapine) [2012 version]
  • Symlin (pramlintide acetate) [2007 version]
  • Tapentadol see Nucynta
  • Tasigna (nilotinib) [2011 version] 
  • Tegretol (carbamazepine) [2011 version]
  • Testim (testosterone) [2011 version]
  • Testosterone Gel [2012 version]
  • Thalomid (thalidomide) [2012 version]
  • Tikosyn (dofetilide) [2011 version]
  • Tofranil (imipramine hydrochloride) [2007 version]
  • Tolectin (tolmetin sodium) [2008 version]
  • Topamax (topiramate) [2011 version]
  • Toradol (ketorolac tromethamine) [2007 version]
  • Tracleer (bosentan) [2009 version]
  • Tranxene (clorazepate dipotassium) [2010 version]
  • Treximet (naproxen sodium and sumatriptan succinate) [2012 version]
  • Tridione (trimethadione) [2012 version]
  • Trileptal (oxcarbazepine) [2011 version]
  • Trilipix (choline fenofibrate) [2012 version] 
  • Trizivir (abacavir sulfate, lamivudine and zidovudine) [2012 version]
  • Truvada (emtricitabine and tenofovir disoproxil fumarate) [2012 version]
  • Tysabri* (natalizumab) [2012 version]
  • Tyzeka (telbivudine) [2011 version] 
  • Ultresa (pancrelipase) [2012 version]
  • Vandetanib (vandetanib) [2011 version]
  • Vibativ (telavancin) [2009 version]
  • Vicoprofen (vicoprofen and ibuprofen) [2008 version]
  • Victoza (liraglutide) [2012 version]
  • Victrelis (boceprevir) [2012 version]
  • Videx (didanosine) [2011 version]
  • Videx EC (didanosine) [2011 version]
  • Viibryd (vilazodone hydrochloride) [2011 version]
  • Vimovo (esomeprazole magnesium and naproxen) [2012 version]
  • Vimpat (lacosamide) [2009 version]
  • Viokace (pancrelipase) [2012 version]  
  • Viramune (nevirapine) [2011 version] 
  • Visicol (sodium phosphate dybasic anhydrous and sodium phosphate monobasic monohydrate) [2009 version]
  • Vivactil (protriptyline hydrochloride) [2007 version]
  • Vivitrol (naltrexone) [2010 version]
  • Voltaren (diclofenac sodium) [2011 version]
  • Votrient (pazopanib hydrochloride) [2012 version]
  • Vyvanse (lisdexamfetamine dimesylate) [2012 version]
  • Wellbutrin (bupropion hydrochloride) [2010 version]
  • Wellbutrin SR (bupropion hydrochloride) [2010 version]
  • Wellbutrin XL (buproprion hydrochloride) [2011 version]
  • Xarelto (rivaroxaban) [2011 version]
  • Xenazine (tetrabenazine) [2011 version]
  • Xeomin* (incobotulinumtoxinA) [2011 version]
  • Xiaflex* (collagenase clostridium histolyticum) [2011 version]
  • Xolair* (omalizumab) [2010 version]
  • Xyrem (sodium oxybate) [2005 version]
  • Yervoy* (ipilimumab) [2011 version]
  • Zarontin (ethosuximide) [2012 version]
  • Zelboraf (vemurafenib) [2011 version]
  • Zenpep (pancrelipase) [2011 version]
  • Zerit (stavudine) [2011 version]
  • Ziagen (abacavir sulfate) [2012 version]
  • Zipsor (diclofenac potassium) [2009 version]
  • Zoloft (sertraline hydrochloride) [2011 version]
  • Zolpidem (zolpidem tartrate) [2008 version] 
  • Zolpimist (zolpidem tartrate) [2008 version]
  • Zonegran (zonisamide) [2012 version]
  • Zortress (everolimus) [2012 version] 
  • Zyban (bupropion hydrochloride) [2012 version]
  • Zyprexa (olanzapine) [2010 version]
  • Zyprexa Relprevv (olanzapine) [2012 version]
  •  

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