Almotriptan

Almotriptan tablets, USP are 5HT 1B/1D receptor agonist (triptan) indicated for: Acute treatment of migraine attacks in adults with a history of migraine with or without aura. 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. Important limitations: Use only after a clear diagnosis of migraine has been established. In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established. Not intended for the prophylactic therapy of migraine. Not indicated for the treatment of cluster headache

Almotriptan binds with high affinity to 5-HT 1D, 5-HT 1B, and 5-HT 1F receptors. Almotriptan has weak affinity for 5-HT 1A and 5-HT 7 receptors, but has no significant affinity or pharmacological activity at 5-HT 2, 5-HT 3, 5-HT 4, 5-HT 6, alpha or beta adrenergic, adenosine (A 1, A 2 ), angiotensin (AT 1, AT 2 ), dopamine (D 1, D 2 ), endothelin (ET A, ET B ), or tachykinin (NK 1, NK 2, NK 3 ) binding sites.

Adults and adolescents age 12 to 17 years: 6.25 mg or 12.5 mg single dose, may repeat after 2 hours if headache returns, benefit of second dose in patients who have failed to respond to first dose has not been established, maximum daily dose 25 mg. Patients with hepatic or severe renal impairment: 6.25 mg starting dose, maximum daily dose 12.5 mg

Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease. Cerebrovascular syndromes (e.g., history of stroke or TIA). Peripheral vascular disease (including ischemic bowel disease). Uncontrolled hypertension. Do not use almotriptan tablets within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT 1 agonist, e.g., another triptan. Hemiplegic or basilar migraine. Known hypersensitivity to almotriptan tablets

Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm. It is strongly recommended that almotriptan tablets 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 almotriptan tablets use in the absence of known cardiovascular disease. If almotriptan tablets are considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physician’s office setting. Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw: generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD.

Serious cardiac reactions, including myocardial infarction, have occurred following the use of almotriptan 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.

Do not use almotriptan tablets and ergotamine-containing or ergot-type medications within 24 hours of each other. Do not use almotriptan tablets and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other. SSRI or SNRI: life-threatening serotonin syndrome reported during combined use with triptans. Ketoconazole: use single dose of almotriptan tablets 6.25 mg, maximum almotriptan tablets daily dose 12.5 mg

Store at 25°C (77°F), excursions permitted from 15° to 30°C (59° to 86°F).