SPL Set ID: 2b9c8b1e-6193-4d8e-9b50-6aca27294263
1 drug(s) with this SPL Set ID
Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[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 (white to off-white, capsule shaped film coated tablets, debossed with “1 C” on one side and plain on other side.) and 1 mg (light blue, capsule shaped film-coated tablets, debossed with “2 C” on one side and plain on 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: silicified microcrystalline cellulose, maltodextrin, croscarmellose sodium, stearic acid, hypromellose, titanium dioxide, macrogol/polyethylene glycol, triacetin. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake. Structure