SPL Set ID: 29b6b4ca-aeef-1295-e063-6394a90a21b9
1 drug(s) with this SPL Set ID
Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is an off-white to white color powder with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6Hpyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13 H 13 N 3 ∙C 4 H 6 O 6 . The chemical structure is: Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg capsular, biconvex, white to off-white film-coated tablets, debossed with “0.5” on one side and plain on the other side and a 1 mg capsular, biconvex, light blue film-coated tablets, debossed with “1.0” on one side and plain on the other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, purified water, magnesium stearate, The tablets are film-coated with a coating material containing hypromellose, triacetin, titanium dioxide. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/ indigo carmine aluminum lake. Varenicline Structure