7 results found.
Axert (almotriptan) tablets
... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Axert (almotriptan) tablets Prescribing Information-- Axert (almotriptan) tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-April 2009 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS AND PRECAUTIONS Hypersensitivity WARNINGS and PRECAUTIONS Hypersensitivity ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm153834.htm
Axert (almotriptan malate) Tablets 6.25 and 12.5 mg
... Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Safety Home >Safety >MedWatch The FDA Safety Information and Adverse Event Reporting Program >Safety Information Section Contents Menu MedWatch The FDA Safety Information and Adverse Event Reporting Program Safety Information Drug Safety Labeling Changes-Resources for You Prescribing Information-- Axert (almotriptan malate) Tablets 6.25 and 12.5 mg March 2009 Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)-March 2009 The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT / MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format. Summary View Sections Modified Sections Modified Summary of Changes to Contraindications and Warnings WARNINGS Serotonin Syndrome PRECAUTIONS ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm133511.htm
... E F G H I J K L M N O P Q R S T U V W X Y Z A Abacavir sulfate Abilify (aripiprazole) AbobotulinumtoxinA Accolate (zafirlukast) Accupril (quinapril) Accutane (isotretinoin) Aceon (perindopril) Aciphex (rabeprazole sodium) Actimmune (interferon gamma-1b) Actonel (risedronate) Actoplus Met (pioglitazone) Actos (pioglitazone) Adalimumab Advair Diskus (fluticasone propionate; salmeterol xinafoate) Adderall (amphetamine salts) Alendronate Alemtuzumab Aleve (naproxen sodium) Alimta (pemetrexed) Alli (orlistat) Almotriptan malate Alosetron hydrochloride Altace (ramipril) Ambien (zolpidem tartrate) Amerge (naratriptan) Amiodarone Amiodarone / Simvastatin Amnesteem (isotretinoin) Amphetamine salts Anaprox (naproxen sodium) AndroGel 1 %Aprotinin Aranesp (darbepoetin alpha) Arava (leflunomide) Aredia (pamidronate) Arformoterol tartrate Aripiprazole Aspirin Atacand (candesartan) Atomoxetine Avalide (irbesartan / hydrochlorothiazide) Avandamet (rosiglitazone) Avandaryl (rosiglitazone) Avandia (rosiglitazone) Avapro (irbesartan) Avastin (bevacizumab) Avelox (moxifloxacin) Axert (almotriptan malate) Azor (olmesartan / amlodipine) back to ...
URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm
... treat depression and other mood disorders. The FDA has requested that all manufacturers of triptans, SSRIs and SNRIs update their prescribing information to warn of the possibility of serotonin syndrome when triptans and SSRIs or SNRIs are taken together. Drug Names SSRIs and a Combination Drug Containing an SSRI SNRIs Triptans Celexa (citalopram) Fluvoxamine Lexapro (escitalopram) Paxil (paroxetine) Prozac (fluoxetine) Symbyax (olanzapine / fluoxetine) Zoloft (sertraline) Cymbalta (duloxetine) Effexor (venlafaxine) Meridia (sibutramine )* Amerge (naratriptan) Axert (almotriptan) Frova (frovatriptan) Imitrex (sumatriptan) Maxalt and Maxalt-MLT (rizatriptan) Relpax (eletriptan Zomig and Zomig ZMT (zolmitriptan)*Sibutramine (Meridia ), a drug approved for weight loss but not depression, is a SNRI and should therefore be used with caution with triptans and other serotonergic drugs. Sibutramine label [PDF]-Related Information Information About Triptans-Contact Us Report a Serious Problem 1-800-332-1088 1-800-FDA-0178 Fax MedWatch Online Regular Mail: Use postage-paid FDA Form 3500 Mail to: MedWatch 5600 Fishers Lane Rockville, MD 20857- ...
URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm124349.htm
... Skip to Section Content Menu Skip to Common Links Enter Search terms A-Z Index Home Food Drugs Medical Devices Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Radiation-Emitting Products Tobacco Products-Drugs Home >Drugs >Drug Safety and Availability >Postmarket Drug Safety Information for Patients and Providers Section Contents Menu Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Index to Drug-Specific Information Approved Risk Evaluation and Mitigation Strategies (REMS) Postmarketing Safety Evaluation of New Molecular Entities: Final Report Drug Safety Information for Healthcare Professionals-Information About Triptans Almotriptan (Axert ); Eletriptan (Relpax ); Frovatriptan (Frova ); Naratriptan (Amerge ); Rizatriptan (Maxalt ); Sumatriptan (Imitrex ); Zolmitriptan (Zomig) A life-threatening condition called serotonin syndrome can happen when medicines used to treat migraine headaches, 5-hydroxytryptamine receptor agonists (triptans) and medicines used to treat depression, selective serotonin reuptake inhibitors (SSRIs) and selective serotonin / norepinephrine reuptake inhibitors (SNRIs ), are used together.-Related Information Information for Healthcare Professionals: Selective Serotonin Reuptake Inhibitors (SSRIs ), Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs ), 5-Hydroxytryptamine ...
URL: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm
March 2009 Drug Safety Labeling Changes
... mg / mL X X X X PPI Theophylline in 5 %Dextrose injection, USP, Flexible Plastic Container X X X X Tracleer (bosentan) 62.5 and 125 mg Tablets X X MG (Click on drug name to go to detailed view) BW C W P AR PPI / MG Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) X X Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets X X Axert (almotriptan malate) Tablets 6.25 and 12.5 mg X X X PPI Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg X X X MG Frova (frovatriptan succinate) Tablets 2.5 mg X X X X Lexiscan (regadenoson) Injection X X X Spiriva HandiHaler inhalation powder X X X (Click on drug name to go to detailed view) BW C W P AR PPI / MG NegGram (nalidixic acid) Caplets X Novothyrox (levothyroxine sodium) Tablets X Tarka (trandolopril / verapamil hydrochloride) 2 / 180, 1 ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm133470.htm
Safety-Related Drug Labeling Changes
... / clarithromycin 500 mg) X X X Soma Compound (200 mg of carisoprodol and 325 mg of aspirin) X X X X (Click on drug name to go to detailed view) BW C W P AR PPI / MG Aleve (220 mg naproxen sodium) caplet, tablet, and gelcap [OTC] X Aleve Liquid Gels (220 mg naproxen sodium) capsules X Aleve-D Sinus & Cold and Aleve-D Sinus & Headache (naproxen sodium, 220 mg and pseudoephedrine HCl, 120 mg) extended-release tablets X Axert (almotriptan) tablets X X Carbatrol (carbamazepine) Extended-Release Capsules*antiepileptic drugs label change X X Celontin (methsuximide) Capsules*antiepileptic drugs label change X X Depakene (valproic acid) Capsules and Oral Solution*antiepileptic drugs label change X X Depakote (divalproex sodium) Delayed Release Tablets Depakote ER (divalproex sodium) Extended Release Tablets Depakote (divalproex sodium) Sprinkle Capsules*antiepileptic drugs label change X X Depo-Medrol (methylprednisolone acetate injectable suspension, USP) X X X Dilantin-125 (phenytoin oral suspension, USP) Suspension*antiepileptic drugs ...
URL: http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm153519.htm
