Generic Name and Formulations:
Almotriptan (as malate) 6.25mg, 12.5mg; tabs.

Company:
Janssen Pharmaceuticals, Inc
Indications for AXERT:
Acute treatment of migraine attacks in adults. Acute treatment of migraine headache pain in adolescents age 12–17yrs with a history of migraine attacks lasting ≥4hrs (when untreated).

Limitations Of use:
Confirm diagnosis. Not established for adolescents with migraine-associated symptoms or in older males for cluster headaches. Do not use for migraine prophylaxis.

Adult:
6.25–12.5mg single dose; may repeat once after 2hrs; max 25mg/24hrs. Hepatic or severe renal impairment (CrCl 10–30mL/min) or concomitant potent CYP3A4 inhibitors (eg, ketoconazole): initially 6.25mg once; max 12.5mg/24hrs. The safety of treating an average of more than 4 migraines over 30 days is not established.

Children:
Not established.

Pharmacological Class:
Selective 5-HT1B/1D receptor agonist.

Contraindications:
Ischemic heart disease (eg, angina pectoris, silent ischemia, history of MI). Coronary artery vasospasm (eg, Prinzmetal's variant angina). Other significant cardiovascular disease. Uncontrolled hypertension. Cerebrovascular events (eg, stroke, TIA). Peripheral vascular disease (eg, ischemic bowel disease). Basilar or hemiplegic migraine. Within 24hrs of other 5-HT1 agonists or ergot-type drugs.

Warnings/Precautions:
Reeva luate if angina or ischemia symptoms (eg, ischemic bowel syndrome, Raynaud's syndrome) occur, or if no response after 1st dose. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary artery disease (eg, postmenopausal women, men over age 40, hypertension, hypercholesterolemia, obesity, diabetes, smokers, strong family history). Monitor cardiovascular function in long-term intermittent use. Cerebrovascular events (eg, stroke, hemorrhage, TIA), peripheral vascular or colonic ischemia following other 5-HT1 agonists. May exacerbate headache with overuse. Hepatic or renal dysfunction. Sulfonamide hypersensitivity. Elderly. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Interactions:
Methysergide, other ergotamines, or other 5-HT1 agonists: see Contraindications. Monitor for serotonin syndrome with SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram), SNRIs (eg, venlafaxine, duloxetine). Potentiated by ketoconazole, other potent CYP3A4 inhibitors (avoid if concomitant hepatic or renal impairment).

Adverse Reactions:
Nausea, dry mouth, paresthesia, somnolence, dizziness, headache, vomiting, throat/neck/chest pain, pressure or tightness; rare: serious cardiac events, vision loss.

How Supplied:
Tabs 6.25mg—6; 12.5mg—12