SPL Set ID: 124e8e82-972d-4800-9d68-14db416959b5
1 drug(s) with this SPL Set ID
Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT 4 ) receptor agonist. The IUPAC name is: 4-Amino-5-chloro -N- [1-(3-methoxy propyl)piperidin-4-yl] -2, 3- dihydro -1- benzofuran -7-carboxamide succinate.. The molecular formula is C 22 H 32 CIN 3 O 7 and the molecular weight is 485.96. The structural formula is: Prucalopride succinate is a white to almost white powder. It is highly soluble in acidic aqueous media and alkaline aqueous media up to a pH of approximately 9. Each 1-mg film-coated tablet contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silica, colloidal anhydrous. The coating for the 1-mg tablet contains hypromellose, iron oxide yellow, lactose monohydrate, talc, titanium dioxide and triacetin. Each 2-mg film-coated tablet contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose and silica, colloidal anhydrous.. The coating for the 2-mg tablet contains hypromellose, lactose monohydrate, titanium dioxide and triacetin. Image