PRESCRIBING INFORMATION
PAXILŽ
(paroxetine hydrochloride)
Tablets and Oral Suspension
DESCRIPTION
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). The structural formula of paroxetine hydrochloride is:
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.