"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
No gross overdoses in clinical practice have been reported. Coronary vasospasm was observed after intravenous administration of sumatriptan injection [see CONTRAINDICATIONS]. 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 apparent elimination half-life of sumatriptan after ZECUITY administration is about 3 hours [see CLINICAL PHARMACOLOGY], and therefore monitoring of patients after overdose with ZECUITY should continue for at least 15 hours or while symptoms or signs persist.
ZECUITY 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, transient ischemic attack (TIA), or history 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 a MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
- Known hypersensitivity to sumatriptan or components of ZECUITY [see WARNINGS AND PRECAUTIONS].
- Severe hepatic impairment [see CLINICAL PHARMACOLOGY].
- Allergic contact dermatitis to ZECUITY [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 4/3/2014
This monograph has been modified to include the generic and brand name in many instances.
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