Varenicline

11 DESCRIPTION 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 a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6 H -pyrazino[2,3- h][3]benzazepine, (2 R ,3 R )-2,3-dihydroxybutanedioate (1:1). It is freely soluble in water and very slightly soluble in methanol.

35 Daltons, and a molecular formula of C 13 H 13 N 3 • C 4 H 6 O 6 . 5’ on the other side and a 1 mg capsular, biconvex, light blue, film-coated tablet debossed with ‘VA’ on one side and ‘1’ on the other side. 71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base.

The following inactive ingredients are included in the tablets: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide. In addition 1 mg tablet contains FD&C Blue #2.