Source: FDA, National Drug Code (US) Revision Year: 2020
IMITREX tablets contain sumatriptan succinate, a selective 5‑HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:
The empirical formula is C14H21N3O2S•C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off‑white powder that is readily soluble in water and in saline.
Each IMITREX tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 100-mg tablet also contains hypromellose, iron oxide, titanium dioxide, and triacetin.
| Dosage Forms and Strengths |
|---|
|
25-mg Tablets: White, triangular-shaped, film-coated, and debossed with “I” on one side and “25” on the other. Each tablet contains 35 mg of sumatriptan succinate equivalent to 25 mg of sumatriptan. 50-mg Tablets: White, triangular-shaped, film-coated, and debossed with “IMITREX 50” on one side and a chevron shape (^) on the other. Each tablet contains 70 mg of sumatriptan succinate equivalent to 50 mg of sumatriptan. 100-mg Tablets: Pink, triangular-shaped, film-coated, and debossed with “IMITREX 100” on one side and a chevron shape (^) on the other. Each tablet contains 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan. |
| How Supplied |
|---|
|
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 (^) 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 (^) on the other in blister packs of 9 tablets (NDC 0173-0737-01). GlaxoSmithKline, Research Triangle Park, NC 27709 |
| Drug | Countries | |
|---|---|---|
| IMITREX | Canada, Israel, United States |
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