In clinical trials, the highest single doses of IMITREX Nasal Spray administered without significant adverse effects were 40 mg to 12 volunteers and 40 mg to 85 migraine patients, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days without significant adverse events.

Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation. The elimination half-life of sumatriptan is about 2 hours (see CLINICAL PHARMACOLOGY), and therefore monitoring of patients after overdose with IMITREX Nasal Spray should continue for at least 10 hours or while symptoms or signs persist. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

IMITREX Nasal Spray should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive IMITREX Nasal Spray. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction, and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease (see WARNINGS).

Because IMITREX Nasal Spray may increase blood pressure, it should not be given to patients with uncontrolled hypertension.

Concurrent administration of MAO-A inhibitors or use within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated (see CLINICAL PHARMACOLOGY: Drug Interactions and PRECAUTIONS: Drug Interactions). IMITREX Nasal Spray and any ergotamine-containing or ergot-type medication (like dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should IMITREX Nasal Spray and another 5-HT₁ agonist.

IMITREX Nasal Spray should not be administered to patients with hemiplegic or basilar migraine.

IMITREX Nasal Spray is contraindicated in patients with hypersensitivity to sumatriptan or any of its components.

IMITREX Nasal Spray is contraindicated in patients with severe hepatic impairment.

Brand Name: Imitrex Nasal Spray
Generic Name: Sumatriptan

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