Migraine and headache:
Indications for: ZOMIG NASAL SPRAY
Acute treatment of migraine with or without aura.
Limitations of Use:
Use only after a clear diagnosis of migraine has been established. Not indicated for the prevention of migraine attacks. Safety and effectiveness of Zomig have not been established for cluster headache. Nasal Spray: also, not recommended in patients with moderate to severe hepatic impairment.
Initially 2.5mg once; max single dose: 5mg. If headache returns, may repeat once after 2 hrs; max 10mg/day. Reevaluate if no response after 1st dose. The safety of treating an average of more than 4 headaches in a 30-day period has not been established. Moderate to severe hepatic impairment: not recommended; use alternate formulation. Concomitant cimetidine: max single dose: 2.5mg, not to exceed 5mg in 24hr period.
<12yrs: not established.
ZOMIG NASAL SPRAY Contraindications:
Ischemic coronary artery disease disease (angina pectoris, history of MI, documented silent ischemia). Other significant underlying cardiovascular disease. Coronary artery vasospasm (eg, Prinzmetal's angina). Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke, TIA, or hemiplegic or basilar migraine. Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. Within 24 hours of ergot-type drugs or other 5-HT1 agonists. During or within 2 weeks after discontinuing MAOIs (type A).
ZOMIG NASAL SPRAY Warnings/Precautions:
Confirm diagnosis. Exclude underlying cardiovascular disease, supervise 1st dose, and consider monitoring ECG in patients with likelihood of unrecognized coronary disease (eg, postmenopausal women, men over age 40, hypertension, hypercholesterolemia, obesity, diabetes, smokers, strong family history). Discontinue if disturbances in cardiac rhythm occur. Rule out vasospastic reaction before receiving additional doses. Monitor cardiovascular function in long-term intermittent use. Medication overuse headache: detox may be needed. Hepatic dysfunction. Monitor BP. Elderly. Pregnancy. Nursing mothers.
ZOMIG NASAL SPRAY Classification:
Selective 5-HT1B/1D receptor agonist.
ZOMIG NASAL SPRAY Interactions:
MAOIs (type A), methysergide, other ergotamines, other 5-HT1 agonists: see Contraindications. Serotonin syndrome with SSRIs, SNRIs, TCAs, MAOIs; discontinue if suspected. Absorption and half-life increased by cimetidine.
Neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, dry mouth; rare: serious cardiac events. Nasal spray: also taste disturbances, local reactions.
Generic Drug Availability:
Tabs (YES); ZMT tabs, sprayer (NO)
Tabs, ZMT tabs 2.5mg—6; Tabs, ZMT tabs 5mg—3; Single-dose sprayer—6