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Sumavel DosePro

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Sumavel DosePro

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OVERDOSE

Patients (N = 269) have received single injections of 8 to 12 mg sumatriptan without significant adverse effects. Volunteers (N = 47) have received single subcutaneous doses of up to 16 mg without serious adverse events.

No gross overdoses in clinical practice have been reported. The half-life of elimination of sumatriptan is about 2 hours [see CLINICAL PHARMACOLOGY], and therefore monitoring of patients after overdose with subcutaneous sumatriptan should continue while symptoms or signs persist, and for at least 10 hours. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

CONTRAINDICATIONS

Intravenous Administration

Sumavel DosePro is not designed to administer sumatriptan injection intravenously. Do not administer intravenously since sumatriptan may cause coronary vasospasm.

Ischemic or Vasospastic Coronary Artery Disease

Do not use Sumavel DosePro in patients with ischemic heart disease (e.g. 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 Sumavel DosePro in patients with cerebrovascular syndromes including (but not limited to) strokes of any type as well as transient ischemic attacks. [see WARNINGS AND PRECAUTIONS]

Peripheral Vascular Disease

Do not use Sumavel DosePro in patients with peripheral vascular disease including (but is not limited to) ischemic bowel disease. [see WARNINGS AND PRECAUTIONS]

Uncontrolled Hypertension

Because Sumavel DosePro may increase blood pressure, do not use in patients with uncontrolled hypertension. [see WARNINGS AND PRECAUTIONS]

Do not use within 24 hours of treatment with Ergotamine-Containing or Ergot-Type Medications or Other 5-HT1 Agonists (e.g. triptans)

Do not use Sumavel DosePro and any ergotamine-containing or ergot-type medication (such as dihydroergotamine or methysergide) within 24 hours of each other; do not use Sumavel DosePro and another 5-HT1 agonist (e.g. triptan) within 24 hours of each other (with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour) [see DRUG INTERACTIONS].

Hemiplegic or Basilar Migraine

Do not use Sumavel DosePro in patients with hemiplegic or basilar migraine.

Hypersensitivity

Sumavel DosePro is contraindicated in patients with known hypersensitivity to sumatriptan.

Last reviewed on RxList: 8/2/2011
This monograph has been modified to include the generic and brand name in many instances.

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