"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"...
AMERGE (naratriptan) Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
AMERGE (naratriptan) Tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of AMERGE (naratriptan) Tablets have not been established for cluster headache, which is present in an older, predominantly male population.
DOSAGE AND ADMINISTRATION
In controlled clinical trials, single doses of 1 and 2.5 mg of AMERGE (naratriptan) Tablets taken with fluid were effective for the acute treatment of migraines in adults. A greater proportion of patients had headache response following a 2.5-mg dose than following a 1-mg dose (see Clinical Trials). Individuals may vary in response to doses of AMERGE (naratriptan) Tablets. The choice of dose should therefore be made on an individual basis, weighing the possible benefit of the 2.5-mg dose with the potential for a greater risk of adverse events. If the headache returns or if the patient has only partial response, the dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24-hour period. There is evidence that doses of 5 mg do not provide a greater effect than 2.5 mg.
The safety of treating, on average, more than 4 headaches in a 30-day period has not been established.
The use of AMERGE (naratriptan) is contraindicated in patients with severe renal impairment (creatinine clearance, < 15 mL/min) because of decreased clearance of the drug (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY). In patients with mild to moderate renal impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a lower starting dose should be considered.
The use of AMERGE (naratriptan) is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C) because of decreased clearance (see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY). In patients with mild or moderate hepatic impairment, the maximum daily dose should not exceed 2.5 mg over a 24-hour period and a lower starting dose should be considered (see CLINICAL PHARMACOLOGY).
AMERGE Tablets 1 and 2.5 mg of naratriptan (base) as the hydrochloride. AMERGE (naratriptan) Tablets, 1 mg, are white, D-shaped, film-coated tablets debossed with “GX CE3” on one side in blister packs of 9 tablets (NDC 0173-0561-00). AMERGE (naratriptan) Tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” onone side in blister packs of 9 tablets (NDC 0173-0562-00).
Store at controlled room temperature, 20 ° to 25 ° C (68 ° to 77 ° F) (see USP).
GlaxoSmithKline., Research Triangle Park, NC 27709. April 2007.
Last reviewed on RxList: 9/3/2010
This monograph has been modified to include the generic and brand name in many instances.
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