Generic Name and Formulations:
Almotriptan (as malate) 6.25mg, 12.5mg; tabs.
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 ≥4 hours (when untreated).
Adults and Children's Dose:
<12yrs: not recommended. ≥12yrs: 6.25mg or 12.5mg single dose; may repeat once after 2 hours; max 25mg/24hrs. Hepatic or severe renal impairment (CrCl 10–30mL/minute) or concomitant potent CYP3A4 inhibitors (eg, ketoconazole): initially 6.25mg once; max 12.5mg/24 hours. The safety of treating an average of more than 4 headaches over 30 days is not established.
Selective 5-HT1B/1D receptor agonist.
Ischemic heart disease: history or symptoms (eg, angina pectoris, silent ischemia, MI). Vasospastic coronary artery disease (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 24 hours of other 5-HT1 agonists or ergot-type drugs.
Confirm diagnosis. Reevaluate if angina or ischemia symptoms (eg, ischemic bowel 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, TIA), peripheral vascular or colonic ischemia following other 5-HT1 agonists. Hepatic or renal dysfunction. Sulfonamide hypersensitivity. Elderly. Pregnancy (Cat.C). Nursing mothers.
Methysergide, other ergotamines, or other 5-HT1 agonists: see Contraindications. Monitor for serotonin syndrome with SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline), SNRIs (eg, venlafaxine, duloxetine). Potentiated by ketoconazole, other potent CYP3A4 inhibitors (avoid if concomitant hepatic or renal impairment).
Nausea, dry mouth, paresthesia, somnolence, dizziness, headache, throat/neck/chest pain, pressure or tightness; serious cardiac events (rare).
Tabs 6.25mg—6; 12.5mg—12
- 12 tablets of 12.5mg dose packs (Qty:1)
- appx. price $421.00
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