Source: FDA, National Drug Code (US) Revision Year: 2020
AMERGE contains naratriptan hydrochloride, a selective 5-HT1B/1D receptor agonist. Naratriptan hydrochloride is chemically designated as N-methyl-3-(1-methyl-4-piperidinyl)-1H-indole-5-ethanesulfonamide monohydrochloride, and it has the following structure:
The empirical formula is C17H25N3O2S•HCl, representing a molecular weight of 371.93. 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.
| Dosage Forms and Strengths |
|---|
|
1-mg white tablets, D-shaped, film-coated, and debossed with “GX CE3”. 2.5-mg green tablets, D-shaped, film-coated, and debossed with “GX CE5”. |
| How Supplied |
|---|
|
AMERGE tablets containing 1 mg and 2.5 mg of naratriptan (base) as the hydrochloride salt. AMERGE 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 tablets, 2.5 mg, are green, D-shaped, film-coated tablets debossed with “GX CE5” on one side in blister packs of 9 tablets (NDC 0173-0562-00). Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709 |
| Drug | Countries | |
|---|---|---|
| AMERGE | Canada, Japan, United States |
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