Axert Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
AXERT® is a 5HT1B/1D receptor agonist (triptan) indicated for: Acute treatment of migraine attacks in adults with a history of migraine with or without aura (1.1)Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more (1.1) Important limitations: Use only after a clear diagnosis of migraine has been established (1.2)In adolescents age 12 to 17 years, efficacy of AXERT® on migraine-associated symptoms was not established (1.2)Not intended for the prophylactic therapy of migraine (1.2)Not indicated for the treatment of cluster headache (1.2)
What should I know before taking it?
It is not known whether almotriptan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AXERT® is administered to a nursing woman. Levels of almotriptan in rat milk were up to 7 times higher than in rat plasma. Safety and efficacy of AXERT® in pediatric patients under the age of 12 years have not been established. The pharmacokinetics, efficacy, and safety of AXERT® have been evaluated in adolescent patients, age 12 to 17 years [see Clinical Pharmacology (12.3) and Clinical Studies (14.2)]. In a clinical study, AXERT® 6.25 mg and 12.5 mg were found to be effective for the relief of migraine headache pain in adolescent patients age 12 to.
What important warnings are listed?
Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm (5.1)It is strongly recommended that AXERT® not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors. In very rare cases, serious cardiovascular events have been reported in association with AXERT® use in the absence of known cardiovascular disease. If AXERT® is considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physician's office setting (5.1)Sensations of pain, tightness, pressure, and heaviness in the chest, throat,.
How is this medication usually taken?
AXERT® (almotriptan malate) Tablets are available as white, coated, circular, biconvex tablets in the following dosage strengths: 6.25 mg tablet with red code imprint "2080" 12.5 mg tablet with blue stylized imprint "A."
What side effects are listed?
Serious cardiac reactions, including myocardial infarction, have occurred following the use of AXERT® (almotriptan malate) Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported in association with triptans have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see Contraindications (4.1) and Warnings and Precautions (5.1)]. The following adverse reactions are discussed in more detail in other sections of the labeling: Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events [see Warnings and.
What interactions are listed?
For additional detailed information on drug interactions, see Clinical Pharmacology, Pharmacokinetics (12.3) .
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=886c13fa-4547-4411-88aa-8e23a7a698f6
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.