"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 has been established. If a patient has no response to the first migraine attack treated with RELPAX, reconsider the diagnosis of migraine before RELPAX is administered to treat any subsequent attacks.
- RELPAX is not intended for the prevention of migraine attacks.
- Safety and effectiveness of RELPAX have not been established for cluster headache.
DOSAGE AND ADMINISTRATION
The maximum recommended single dose is 40 mg.
In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose [see Clinical Studies].
If the migraine has not resolved by 2 hours after taking RELPAX, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg.
The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established.
Dosage Forms And Strengths
20 mg Tablets: Orange, round, convex shaped, film-coated, with “PFIZER” and “REP20” debossed.
40 mg Tablets: Orange, round, convex shaped, film-coated, with “PFIZER” and “REP40” debossed.
Storage And Handling
RELPAX Tablets containing 20 mg or 40 mg eletriptan (base) as the hydrobromide salt. RELPAX Tablets are orange, round, convex shaped, film-coated tablets with appropriate debossing.
They are supplied in the following strengths and package configurations:
|Package Configuration||Tablet Strength (mg)||NDC Code||Debossing|
|Carton of 12 tablets. Two blisters of 6 tablets in each carton.||40 mg||0049-2340-05||REP40 and Pfizer|
|Blister of 6 tablets||20 mg||0049-2330-45||REP20 and Pfizer|
|Blister of 6 tablets||40 mg||0049-2340-45||REP40 and Pfizer|
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Distributed by: Roerig, Division of Pfizer Inc, Y, NY 10017. Revised September 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/21/2013
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