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ZOMIG^® (zolmitriptan) Prescribing Information

ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating Tablets full Prescribing Information
ZOMIG Nasal Spray full Prescribing Information

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Indication and Important Safety Information

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. If a patient has no response for the first migraine attack treated with ZOMIG, the diagnosis of migraine should be reconsidered before ZOMIG is administered to treat any subsequent attacks. 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.

Important Safety Information

• ZOMIG is contraindicated in patients with
  • Ischemic heart disease (eg, silent ischemia, angina), coronary artery vasospasm, or other significant underlying cardiovascular disease
  • Cerebrovascular syndromes (eg, history of stroke or TIA)
  • Peripheral vascular disease (eg, ischemic bowel disease)
  • Uncontrolled hypertension
• Use of ZOMIG is contraindicated within 24 hours of another 5-HT₁ agonist, ergotamine-containing or ergot-type medication, or within 2 weeks of an MAO-A inhibitor
• ZOMIG should not be administered to patients with hemiplegic or basilar migraine
• 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
• Patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other accessory cardiac conduction pathways should not receive ZOMIG
• Development of a potentially life-threatening serotonin syndrome may occur with triptans particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
• Phenylketonuric patients should be informed that ZOMIG-ZMT^® (zolmitriptan) Orally Disintegrating Tablets contains phenylalanine
• ZOMIG should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus
• Side Effects: The most common adverse reactions in clinical trials for ZOMIG and ZOMIG-ZMT were paresthesia, asthenia, nausea, dizziness, pain, chest or neck tightness or heaviness, somnolence, and warm sensation
• Side Effects: The most common adverse reactions in clinical trials for ZOMIG Nasal Spray were unusual taste, paresthesia, hyperesthesia, and dizziness

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