Prescribing Zomig

• Important Safety Information
• Indication
• Prescribing Information

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• 3 Formulations of ZOMIG
  • ZOMIG-ZMT
  • ZOMIG Nasal Spray
  • ZOMIG Tablets
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Important Safety Information and Indication

Important Safety Information

• Zomig is contraindicated in patients with
  • History of coronary artery disease (CAD) or coronary artery vasospasm
  • Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (within 24 hours) use of another 5-HT₁ agonist (eg, another triptan), or an ergotamine-containing medication
  • Monamine oxidase (MAO)-A inhibitor used in past 2 weeks
  • Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray
• Myocardial ischemia, myocardial infarction and Prinzmetal Angina: Perform cardiac evaluation in patients with multiple risk factors and, if satisfactory, administer first dose of ZOMIG in a medically supervised setting
• Arrhythmias: Discontinue ZOMIG if these occur
• Sensations of tightness, pain and pressure in the chest, throat, neck, and jaw commonly occur after treatment with 5-HT₁ agonists like ZOMIG, and is usually non-cardiac in origin: Perform a cardiac evaluation if these patients are at cardiac risk
• Cerebrovascular events, some fatal; non-coronary Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions; and increases in blood pressure (which have been very rarely associated with serious clinical events) have been reported with ZOMIG. Discontinue use of ZOMIG if any of these events occur
• Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
• Serotonin syndrome may occur with triptans, including ZOMIG, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Discontinue ZOMIG if serotonin syndrome is suspected
• Phenylketonuric patients should be informed that Zomig-ZMT^® (zolmitriptan) Orally Disintegrating Tablets contain phenylalanine
• The most common adverse reactions (≥5% and > placebo) for Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets were neck/throat/jaw pain, dizziness, paresthesia; asthenia; somnolence; warm/cold sensation; nausea; heaviness sensation; and dry mouth
• The most common adverse reactions (≥5% and > placebo; in any dosage strength) in clinical trials for Zomig Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness

Indication

Zomig is indicated for the acute treatment of migraine with or without aura in adults. Only use ZOMIG if a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache.

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.