SUMAVEL® DosePro® (sumatriptan injection) is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache.
Limitations of Use:
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of
For triptan-naïve patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administrating the first
Life-threatening arrhythmias have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue
Sensations of tightness, pain, pressure, and heaviness have been reported in the chest, throat, neck, and jaw after treatment with
Cerebrovascular events, some fatal; non-coronary vasospastic reactions such as peripheral or gastrointestinal vascular ischemia and Raynaud’s syndrome; and increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with
Overuse of acute migraine drugs may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary.
Serotonin syndrome may occur with
In controlled clinical trials with sumatriptan injection, the most common adverse reactions (≥ 5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
SUMAVEL® is a registered trademark of Endo International plc or one of its affiliates.
DosePro® is a registered trademark of Zogenix, Inc.
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