"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 "...
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.
Additional Zecuity Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find the secrets to longer life.