Almotriptan Disease Interactions

The group of drugs known as 5-hydroxytryptamine1 receptor (5-HT1) agonists can cause vasospastic reactions, including coronary vasospasm, peripheral vascular ischemia, and colonic ischemia. Rarely, serious adverse cardiac events including acute myocardial infarction, arrhythmia, cardiac arrest, and death have been reported within a few hours following the administration of 5-HT1 agonists, in some cases even in patients with no prior history or findings of coronary artery disease (CAD). Significant elevation in blood pressure, including hypertensive crisis, has also been reported on rare occasions in patients with and without a history of hypertension, as have transient increases in blood pressure and peripheral vascular resistance. In general, patients with potentially unrecognized CAD as predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, tobacco use, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) should not be administered 5-HT1 agonists unless a cardiovascular evaluation provides satisfactory clinical evidence indicating the lack of CAD, ischemic heart disease, or other significant underlying cardiovascular disease. As a precaution, the manufacturers recommend that the first dose be administered under medical surveillance in such patients, and that electrocardiographic monitoring be considered during the interval immediately following administration to help detect any asymptomatic cardiac ischemia that may occur. Periodic cardiovascular evaluations should be performed during intermittent, long-term use.

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The use of 5-hydroxytryptamine receptor (5-HT1) agonists is contraindicated in patients with a history or current symptoms or signs of ischemic cardiac, cerebrovascular, and/or peripheral vascular diseases. In addition, these agents should not be used in patients with any other significant underlying cardiovascular disease or uncontrolled hypertension. 5-HT1 agonists can cause vasospastic reactions, including coronary vasospasm, peripheral vascular ischemia, and colonic ischemia. Some serious adverse cardiac events including acute myocardial infarction, arrhythmia, cardiac arrest, and death have been reported within a few hours following the administration of 5-HT1 agonists, in some cases even in patients with no prior history or findings of coronary artery disease (CAD). Significant elevation in blood pressure, including hypertensive crisis, has also been reported on rare occasions in patients with and without a history of hypertension, as have transient increases in blood pressure and peripheral vascular resistance. Cerebrovascular events have included cerebral hemorrhage, subarachnoid hemorrhage, and stroke, some resulting in fatalities. However, the relationship to 5-HT1 agonists is uncertain and, in a number of cases, the cerebrovascular events may have been primary where symptoms were mistaken to be migraine.

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Almotriptan is partially metabolized by the liver. The pharmacokinetics of almotriptan have not been assessed in patients with hepatic impairment. Based on the known mechanisms of clearance of almotriptan, the maximum decrease in clearance expected due to hepatic impairment would be 60%. The manufacturer recommends that a starting dose of 6.25 mg be used in patients with significantly impaired hepatic function, and that the maximum dosage not exceed 12.5 mg per 24-hour period.

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Approximately 40% of an administered dose of almotriptan is excreted unchanged in the urine. Following oral administration in patients with renal impairment, the clearance of almotriptan was approximately 65% lower in patients with severe impairment (CrCl = 10 to 30 mL/min) and 40% lower in patients with moderate impairment (CrCl = 31 to 71 mL/min) compared to healthy controls. Peak plasma concentrations of almotriptan increased by approximately 80% in these patients. The manufacturer recommends that a starting dose of 6.25 mg be used in patients with significantly impaired renal function, and that the maximum dosage not exceed 12.5 mg per 24-hour period.

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