"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
Limitations of Use
- 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.
DOSAGE AND ADMINISTRATION
The recommended starting dose of ZOMIG is 1.25 mg or 2.5 mg. The 1.25 mg dose can be achieved by manually breaking the functionally-scored 2.5 mg tablet in half. The maximum recommended single dose of ZOMIG is 5 mg.
In controlled clinical trials, a greater proportion of patients had headache response following a 2.5 mg or 5 mg dose than following a 1 mg dose. There was little added benefit from the 5 mg dose compared to the 2.5 mg dose, but adverse reactions were more frequent with the 5 mg dose.
If the migraine has not resolved by 2 hours after taking ZOMIG, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 10 mg in any 24-hour period.
The safety of ZOMIG in the treatment of an average of more than three migraines in a 30-day period has not been established.
Administration of ZOMIG-ZMT Orally Disintegrating Tablets
Instruct patients not to break ZOMIG-ZMT orally disintegrating tablets because they are not functionally-scored. Administration with liquid is not necessary.
Orally disintegrating tablets are packaged in a blister pack. Instruct patients not to remove the tablet from the blister until just prior to dosing. Subsequently, instruct patients to peel the blister pack open, and to place the orally disintegrating tablet on the tongue, where it will dissolve and it will be swallowed with the saliva.
Dosing in Patients with Hepatic Impairment
The recommended dose of ZOMIG in patients with moderate to severe hepatic impairment is 1.25 mg (one-half of one 2.5 mg ZOMIG tablet) because of increased zolmitriptan blood levels in these patients and elevation of blood pressure in some of these patients. Limit the total daily dose in patients with severe hepatic impairment to no more than 5 mg per day.
The use of ZOMIG-ZMT orally disintegrating tablets is not recommended in patients with moderate or severe hepatic impairment because these orally disintegrating tablets should not be broken in half [see Use in Specific Populations, and CLINICAL PHARMACOLOGY].
Dosing in Patients taking Cimetidine
Dosage Forms And Strengths
2.5 mg Tablets: Yellow, biconvex, round, film-coated identified with “ZOMIG” and “2.5” debossed on one side (functionally-scored).
5 mg Tablets: Pink, biconvex, round, film-coated identified with “ZOMIG” and “5” debossed on one side (not scored).
2.5 Orally Disintegrating Tablets: White, flat-faced, round, uncoated, bevelled identified with a debossed “Z” on one side.
5 mg Orally Disintegrating Tablets: White, flat-faced, round, uncoated, bevelled identified with a debossed “Z” and “5” on one side.
Storage And Handling
2.5 mg Tablets - Yellow, biconvex, round, film-coated, functionally-scored tablets containing 2.5 mg of zolmitriptan identified with “ZOMIG” and “2.5” debossed on one side are supplied in cartons containing a blister pack of 6 tablets (NDC 64896-671-51).
5 mg Tablets – Pink, biconvex, round, film-coated tablets containing 5 mg of zolmitriptan identified with “ZOMIG” and “5” debossed on one side are supplied in cartons containing a blister pack of 3 tablets (NDC 64896-672-50).
2.5 mg Orally Disintegrating Tablets - White, flat-faced, round, uncoated, bevelled tablet containing 2.5 mg of zolmitriptan identified with a debossed “Z” on one side are supplied in cartons containing a blister pack of 6 orally disintegrating tablets (NDC 64896-691-51).
5 mg Orally Disintegrating Tablets - White, flat-faced, round, uncoated, bevelled tablet containing 5 mg of zolmitriptan identified with a debossed “Z” and “5” on one side and plain on the other are supplied in cartons containing a blister pack of 3 orally disintegrating tablets (NDC 64896692-50).
Store ZOMIG Tablets and ZOMIG-ZMT Tablets at controlled room temperature, 20-25°C (68-77°F) [see USP]. Protect from light and moisture.
Distributed by:Impax Pharmaceuticals A Division of Impax Laboratories, Inc. Hayward, CA 94544.
Last reviewed on RxList: 10/1/2012
This monograph has been modified to include the generic and brand name in many instances.
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