Axert (Almotriptan Malate) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

Ergot-Containing Drugs

These drugs have been reported to cause prolonged vasospastic reactions. Because there is a theoretical basis that these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and AXERT^® within 24 hours of each other should be avoided (see CONTRAINDICATIONS).

Monoamine Oxidase Inhibitors

Coadministration of moclobemide resulted in a 27% decrease in almotriptan clearance and an increase in C_max of approximately 6%. No dose adjustment is necessary.

Other 5-HT_1B/1D Agonists

Concomitant use of other 5-HT_1B/1D agonists within 24 hours of treatment with AXERT^® is contraindicated (see CONTRAINDICATIONS).

Propranolol

The pharmacokinetics of almotriptan were not affected by coadministration of propranolol.

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans (See WARNINGS – Serotonin Syndrome).

Verapamil

Coadministration of almotriptan and verapamil resulted in a 24% increase in plasma concentrations of almotriptan. No dose adjustment is necessary.

Ketoconazole and Other Potent CYP3A4 Inhibitors

Coadministration of almotriptan and the potent CYP3A4 inhibitor ketoconazole (400 mg q.d. for 3 days) resulted in an approximately 60% increase in the area under the plasma concentration-time curve and maximal plasma concentrations of almotriptan. Although the interaction between almotriptan and other potent CYP3A4 inhibitors (e.g., itraconazole, ritonavir, and erythromycin) has not been studied, increased exposures to almotriptan may be expected when almotriptan is used concomitantly with these medications.

OVERDOSAGE

Patients and volunteers receiving single oral doses of 100 to 150 mg of almotriptan did not experience significant adverse events. Six additional normal volunteers received single oral doses of 200 mg without serious adverse events. During clinical trials with AXERT^® (almotriptan malate) Tablets, one patient ingested 62.5 mg in a 5-hour period and another patient ingested 100 mg in a 38-hour period. Neither patient experienced adverse reactions.

Based on the pharmacology of 5-HT agonists, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastrointestinal decontamination (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with AXERT^®. Clinical and electrocardiographic monitoring should be continued for at least 20 hours, even if clinical symptoms are not observed.

It is unknown what effect hemodialysis or peritoneal dialysis has on plasma concentrations of almotriptan.

CONTRAINDICATIONS

AXERT^® (almotriptan malate) Tablets should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina, or other significant underlying cardiovascular disease (see WARNINGS).

Because AXERT^® may increase blood pressure, it should not be given to patients with uncontrolled hypertension (see WARNINGS).

AXERT^® should not be administered within 24 hours of treatment with another 5-HT₁ agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide.

AXERT^® should not be given to patients with hemiplegic or basilar migraine.

AXERT^® is contraindicated in patients who are hypersensitive to almotriptan or any of its ingredients.