Migraine and headache:
Indications for: ZOMIG-ZMT
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.
Zomig-ZMT Orally Disintegrating Tablets
The efficacy of Zomig-ZMT 2.5 mg Orally Disintegrating Tablets was demonstrated in a randomized, placebo-controlled trial (Study 6) that was similar in design to the trials of Zomig tablets. Patients were instructed to treat a moderate to severe headache. Of the 471 patients treated in Study 6, 87% were female and 97% were Caucasian, with a mean age of 41 years (range 18 - 62).
At 2 hours post-dosing, there was a statistically significant greater percentage of patients treated with Zomig-ZMT 2.5 mg with a headache response (reduction in headache severity from moderate or severe pain to mild or no headache) compared to patients treated with placebo (63% vs. 22%).
For patients with migraine-associated photophobia, phonophobia and nausea at baseline, there was a decreased incidence of these symptoms following administration of Zomig-ZMT as compared to placebo.
≥18yrs: Initially 1.25–2.5mg; max single dose: 5mg. If headache returns, may repeat after 2 hrs; max 10mg/day. Reevaluate if no response after 1st dose. The safety of treating an average of more than 3 headaches in a 30-day period has not been established. Moderate to severe hepatic impairment: 1.25mg; severe hepatic impairment: max 5mg/day. Concomitant cimetidine: max single dose: 2.5mg, not to exceed 5mg in 24hr period. ZMT: dissolve on tongue and swallow without water.
<18yrs: not recommended.
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).
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.
Selective 5-HT1B/1D receptor agonist.
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.
Total radioactivity recovered in urine and feces was 65% and 30% of the administered dose, respectively. Mean total plasma clearance is 31.5 mL/min/kg, of which one-sixth is renal clearance. The renal clearance is greater than the glomerular filtration rate suggesting renal tubular secretion.
Generic Drug Availability:
Tabs (YES); ZMT tabs, sprayer (NO)
Tabs, ZMT tabs 2.5mg—6; Tabs, ZMT tabs 5mg—3; Single-dose sprayer—6