Monograph Details
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Pain & Pyrexia
> Migraine and headache
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AXERT |
| Manufacturer |
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Ortho-McNeil Neurologics, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Selective 5-HT1B/1D receptor agonist. |
| Generic Name |
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Almotriptan (as malate) 6.25mg, 12.5mg; tabs. |
| Indications |
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Acute treatment of migraine. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: 6.25mg or 12.5mg once; may repeat once after 2 hours; max 2 doses/24 hours. Hepatic or severe renal impairment (CrCl 10–30mL/minute): 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. |
| Contraindications |
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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. Basilar or hemiplegic migraine. Within 24 hours of other 5-HT1 agonists or ergot-type drugs. |
| Precautions |
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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. Elderly. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
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Methysergide, other ergotamines, or other 5-HT1 agonists: see Contraindications. Monitor for serotonin syndrome with SSRIs (eg, fluoxetine, fluvoxamine, paroxetine, sertraline). May affect, or be affected by, MAOIs or CYP3A4 inhibitors (eg, ketoconazole). |
| Adverse Reactions |
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Nausea, dry mouth, paresthesia, somnolence, dizziness, throat/neck/chest pain, pressure or tightness; serious cardiac events (rare). |
| How Supplied |
Tabs 6.25mg—6
12.5mg—12 |
| Additional Resources |
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• Related Prescribing Note |
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