SPL Set ID: 5da839f9-e2bf-4b83-a410-1226ba4552a1
1 drug(s) with this SPL Set ID
Paroxetine extended-release tablets USP, contains paroxetine hydrochloride, USP an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4R-(4’-fluorophenyl)-3S-[(3’,4’ methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C 19 H 20 FNO 3 •HCl•1/2H 2 O. The molecular weight is 374.8 g/mol (329.4 g/mol as free base). The structural formula of paroxetine hydrochloride, USP is: Paroxetine hydrochloride, USP is white or almost white crystalline powder, having a melting point range of 120 o C to 138 o C and soluble in methanol and in alcohol, slightly soluble in water. Paroxetine extended-release tablets, USP are intended for oral administration. Each extended-release tablet contains 25 mg or 37.5 mg paroxetine equivalent to 28.51 mg or 42.76 mg of paroxetine hydrochloride USP, respectively. Each tablet consists of a hydrophilic matrix that contains the active material. Inactive ingredients consist of colloidal silicon dioxide, glyceryl dibehenate, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, povidone K-30, talc and triethyl citrate. The film-coating material contains hypromellose, polyethylene glycol 400, polyethylene glycol 6000 and titanium dioxide. Additionally, 25 mg tablets contain D&C Red No. 30 Lake and polysorbate 80 and 37.5 mg tablets contain FD&C Blue No. 2 Aluminium Lake and talc. FDA approved dissolution test specifications differ from USP. paroxetine-str.jpg