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Important Safety Information and Indication

Important Safety Information

Zomig is contraindicated
- In ischemic heart disease (eg, silent ischemia, angina, history of myocardial infarction), coronary artery vasospasm, or other significant underlying cardiovascular disease
- In cerebrovascular syndromes (eg, history of stroke or TIA)
- In peripheral vascular disease (eg, ischemic bowel disease)
- In uncontrolled hypertension
- In hemiplegic or basilar migraine
- In patients with hypersensitivity to Zomig
- Within 24 hours of another 5-HT₁ agonist, ergotamine-containing or ergot-type medication, or within 2 weeks of an MAO-A inhibitor
Serious adverse cardiovascular events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm and death, have been reported with Zomig. In very rare cases, these events have occurred in the absence of known cardiovascular disease. It is strongly recommended that Zomig not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors without a satisfactory cardiac evaluation. If the evaluation is satisfactory, administration of the first dose of Zomig should take place in a physician’s office setting
Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw have been reported with Zomig. Patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD
Patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other accessory cardiac conduction pathways should not receive Zomig
Cerebrovascular events including stroke, some fatal; gastrointestinal ischemic events; peripheral vascular ischemia; increases in blood pressure, very rarely associated with significant clinical events; and very rare reports of anaphylaxis have been reported with Zomig
Development of a potentially life-threatening serotonin syndrome may occur with triptans, including Zomig, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Monitor patients carefully if concomitant treatment is clinically warranted
Phenylketonuric patients should be informed that Zomig-ZMT^® (zolmitriptan) Orally Disintegrating Tablets contain phenylalanine
Following administration of cimetidine, the half-life and AUC of Zomig were approximately doubled
Zomig Use in Specific Populations
- Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
- Use with caution in nursing mothers, as it is not known if Zomig is excreted in human milk
- Safety and effectiveness has not been established in pediatric patients or geriatric patients
- In moderate to severe hepatic impairment decreased clearance of Zomig and significant elevation of blood pressure were observed. Doses of Zomig <2.5 mg with blood pressure monitoring are recommended
The most common adverse reactions in clinical trials for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets were paresthesia; asthenia; nausea; dizziness; pain, tightness, pressure or heaviness such as in the chest, throat, neck, or jaw; somnolence; and warm sensation. The most common adverse reactions in clinical trials for Zomig Nasal Spray were unusual taste; paresthesia; hyperesthesia; dizziness; nausea; pain, pressure, and tightness sensations such as in the nose, throat, or chest; somnolence; asthenia; disorder/discomfort of nasal cavity; and dry mouth

Indication

Zomig is indicated for the acute treatment of migraine with or without aura in adults.

Zomig should only be used where a clear diagnosis of migraine has been established. For a given attack, if a patient does not respond to the first dose of Zomig, the diagnosis of migraine headache should be reconsidered before administration of a second dose. Zomig is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of ZOMIG have not been established for cluster headache, which is present in an older, predominantly male population.

Please click here for full Prescribing Information for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets.

Please click here for full Prescribing Information for Zomig Nasal Spray.

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