tablet , film-coated , white , D other
(naratriptan hydrochloride) Tablets
AMERGE Tablets contain naratriptan as the hydrochloride, which is a selective 5-hydroxytryptamine1 receptor subtype agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride
Naratriptan hydrochloride is a white to pale yellow powder that is readily soluble in water. Each AMERGE Tablet for oral administration contains 1.11 or 2.78 mg of naratriptan hydrochloride equivalent to 1 or 2.5 mg of naratriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium hypromellose lactose magnesium stearate microcrystalline cellulose triacetin and titanium dioxide, iron oxide yellow (2.5-mg tablet only), and indigo carmine aluminum lake (FD&C Blue No. 2) (2.5-mg tablet only) for coloring.
AMERGE Tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.
AMERGE 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 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 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 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.
Renal Impairment: The use of AMERGE 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.
Hepatic Impairment: The use of AMERGE 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).
Serious cardiac events, including some that have been fatal, have occurred following the use of 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation