DOSAGE AND ADMINISTRATION:
ZOMIG Tablets
In controlled clinical trials, single doses of 1, 2.5 and 5 mg of ZOMIG Tablets were effective for the acute treatment of migraines in adults. A greater proportion of patients had headache response following a 2.5 or 5 mg dose than following a 1 mg dose (see Table 1). In the only direct comparison of 2.5 and 5 mg, there was little added benefit from the larger dose but side effects are generally increased at 5 mg (see Table 2). Patients should, therefore, be started on 2.5 mg or lower. A dose lower than 2.5 mg can be achieved by manually breaking the scored 2.5 mg tablet in half.
If the headache returns, the dose may be repeated after 2 hours, not to exceed 10 mg within a 24-hour period. Controlled trials have not adequately established the effectiveness of a second dose if the initial dose is ineffective.
The safety of treating an average of more than three headaches in a 30-day period has not been established.
ZOMIG-ZMT Orally Disintegrating Tablets
In a controlled clinical trial, a single dose of 2.5 mg of ZOMIG-ZMT Tablets was effective for the acute treatment of migraines in adults.
If the headache returns, the dose may be repeated after 2 hours, not to exceed 10 mg within a 24-hour period. Controlled trials have not adequately established the effectiveness of a second dose if the initial dose is ineffective.
The safety of treating an average of more than three headaches in a 30-day period has not been established.
Administration with liquid is not necessary. The orally disintegrating tablet is packaged in a blister. Patients should be instructed not to remove the tablet from the blister until just prior to dosing. The blister pack should then be peeled open, and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva. It is not recommended to break the orally disintegrating tablet.
Hepatic Impairment:
Patients with moderate to severe hepatic impairment have decreased clearance of zolmitriptan and significant elevation in blood pressure was observed in some patients. Use of a low dose with blood pressure monitoring is recommended (see CLINICAL PHARMACOLOGY AND WARNINGS).
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