"March 11, 2014 - The U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically "...
Data on overdose of Alsuma and its treatment are lacking in humans. Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) to possibly cause convulsions, tremor, inactivity, erythema of the extremities, reduced respiratory rate, cyanosis, ataxia, mydriasis, injection site reactions (desquamation, hair loss, and scab formation), and paralysis.
The elimination half-life of sumatriptan is about 2 hours [see CLINICAL PHARMACOLOGY], and therefore monitoring of patients after overdose with subcutaneous sumatriptan should continue for at least 10 hours or while symptoms or signs persist.
ALSUMA is contraindicated in patients with:
- Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see WARNINGS AND PRECAUTIONS].
- Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS].
- History of stroke or transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see WARNINGS AND PRECAUTIONS].
- Peripheral vascular disease [see WARNINGS AND PRECAUTIONS].
- Ischemic bowel disease. [see WARNINGS AND PRECAUTIONS].
- Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS].
- Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see DRUG INTERACTIONS].
- Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
- Hypersensitivity to ALSUMA (angioedema and anaphylaxis seen) [see WARNINGS AND PRECAUTIONS].
- Severe hepatic impairment [see CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 6/23/2014
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