Paxil

[Paroxetine]

Drug Description
DESCRIPTION

Tablets and Oral Suspension

PAXIL (paroxetine hydrochloride) is an orally administered psychotropic drug. 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 C19H20FNO3 . HCl . 1/ 2H2O. The molecular weight is 374.8 (329.4 as free base).

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Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120 to 138 C and a solubility of 5.4 mg/ mL in water.

Tablets

Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg– yellow (scored); 20 mg– pink (scored); 30 mg– blue, 40 mg– green. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D& C Red No. 30, D& C Yellow No. 10, FD& C Blue No. 2, FD& C Yellow No. 6.

Suspension for Oral Administration

Each 5 mL of orange-colored, orange-flavored liquid contains paroxetine hydrochloride equivalent to paroxetine, 10 mg. Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methyl paraben, propyl paraben, sodium citrate dihydrate, citric acid anhydrate, sodium saccharin, flavorings, FD& C Yellow No. 6, and simethicone emulsion, USP.