"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
- Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks.
- IMITREX is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of IMITREX Tablets have not been established for cluster headache.
DOSAGE AND ADMINISTRATION
The recommended dose of IMITREX Tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25-mg dose, but doses of 100 mg may not provide a greater effect than the 50-mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies].
If the migraine has not resolved by 2 hours after taking IMITREX Tablets, 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 200 mg in a 24-hour period.
Use after IMITREX Injection
If the migraine returns following an initial treatment with IMITREX (sumatriptan succinate) Injection, additional single IMITREX Tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses. The safety of treating an average of more than 4 headaches in a 30-day period has not been established.
Dosing In Patients With Hepatic Impairment
Dosage Forms And Strengths
25 mg Tablets: White, triangular-shaped, film-coated, and debossed with “I” on one side and “25” on the other.
50 mg Tablets: White, triangular-shaped, film-coated, and debossed with “IMITREX 50” on one side and a chevron shape (A) on the other.
100 mg Tablets: Pink, triangular-shaped, film-coated, and debossed with “IMITREX 100” on one side and a chevron shape (A) on the other.
Storage And Handling
IMITREX Tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate.
IMITREX Tablets, 25 mg, are white, triangular-shaped, film-coated tablets debossed with “I” on one side and “25” on the other in blister packs of 9 tablets (NDC 0173-0735-00).
IMITREX Tablets, 50 mg, are white, triangular-shaped, film-coated tablets debossed with “IMITREX 50” on one side and a chevron shape (A) on the other in blister packs of 9 tablets (NDC 0173-0736-01).
IMITREX Tablets, 100 mg, are pink, triangular-shaped, film-coated tablets debossed with “IMITREX 100” on one side and a chevron shape (A) on the other in blister packs of 9 tablets (NDC 0173-0737-01).
Store between 2°C and 30°C (36°F and 86°F).
GlaxoSmithKline, Research Triangle Park, NC 27709
Last reviewed on RxList: 12/9/2013
This monograph has been modified to include the generic and brand name in many instances.
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