SPL Set ID: e1e9e36c-ce5a-4323-9d20-395bb5e80e64
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-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide succinate. The molecular formula is C 18 H 26 ClN 3 O 3 •C 4 H 6 O 4 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 of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: mannitol, silicified microcrystalline cellulose, magnesium stearate, and Opadry II (White). Opadry II (White) contains: titanium dioxide, polydextrose, hypromellose, triacetin, polyethylene glycol. Each 2-mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: mannitol, silicified microcrystalline cellulose, magnesium stearate, and Opadry II (Pink). Opadry II (Pink) contains: polydextrose, titanium dioxide, hypromellose, triacetin, polyethylene glycol, FD&C Red #40 Allura Red AC Aluminum Lake, FD&C Yellow #6 Sunset Yellow Aluminum Lake, FD&C Blue #2 Indigo Carmine Aluminum Lake. prucalopride-structural-formula-image