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



Ergot-Containing Drugs

These drugs have been reported to cause prolonged vasospastic reactions. Because, in theory, vasospastic effects may be additive, ergotamine-containing or ergot-type medications (like dihydroergotamine, ergotamine tartrate, or methysergide) and AXERT® (almotriptan malate) should not be used within 24 hours of each other [see Contraindications].

5-HT Agonists (e.g., Triptans)

Concomitant use of other 5-HT1 agonists (e.g., triptans) within 24 hours of treatment with AXERT® is contraindicated [see Contraindications].

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors

Cases of life-threatening serotonin syndrome have been reported during combined use of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions, Clinical Pharmacology].

Ketoconazole and Other Potent CYP3A4 Inhibitors

Co-administration of almotriptan and oral ketoconazole, a potent CYP3A4 inhibitor, resulted in an approximately 60% increase in exposure of almotriptan. Increased exposures to almotriptan may be expected when almotriptan is used concomitantly with other potent CYP3A4 inhibitors [see Clinical Pharmacology].

In patients concomitantly using potent CYP3A4 inhibitors, the recommended starting dose of AXERT® is 6.25 mg. The maximum daily dose should not exceed 12.5 mg within a 24-hour period. Concomitant use of AXERT® and potent CYP3A4 inhibitors should be avoided in patients with renal or hepatic impairment [see Clinical Pharmacology].


Signs and Symptoms

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), 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 triptans, hypertension or other more serious cardiovascular symptoms could occur after overdosage.

Recommended Treatment

There is no specific antidote to AXERT®. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.

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.


Ischemic or Vasospastic Coronary Artery Disease, or Other Significant Underlying Cardiovascular Disease

Do not use AXERT® (almotriptan malate) in patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or in 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 and Precautions].

Cerebrovascular Syndromes

Do not use AXERT® in patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks [see Warnings and Precautions].

Peripheral Vascular Disease

Do not use AXERT® in patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see Warnings and Precautions].

Uncontrolled Hypertension

Because AXERT® may increase blood pressure, do not use AXERT® in patients with uncontrolled hypertension [see Warnings and Precautions].

Ergotamine-Containing and Ergot-Type Medications

Do not use AXERT® and ergotamine-containing or ergot-derived medications like dihydroergotamine, ergotamine tartrate, or methysergide within 24 hours of each other [see Drug Interactions].

Concomitant Use With 5-HT Agonists (e.g., Triptans)

AXERT® and other 5-HT1 agonists (e.g., triptans) should not be administered within 24 hours of each other [see Warnings and Precautions and ].

Hemiplegic or Basilar Migraine

Do not use AXERT® in patients with hemiplegic or basilar migraine.


AXERT® is contraindicated in patients with known hypersensitivity to almotriptan or any of its inactive ingredients.

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