Source: FDA, National Drug Code (US) Revision Year: 2020
PAXIL (paroxetine hydrochloride) is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as ()trans4R(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.
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 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.
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, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.
| How Supplied |
|---|
TabletsFilm‑coated, modified‑oval as follows: 10-mg yellow, scored tablets engraved on the front with PAXIL and on the back with 10. 20-mg pink, scored tablets engraved on the front with PAXIL and on the back with 20. 30-mg blue tablets engraved on the front with PAXIL and on the back with 30. 40-mg green tablets engraved on the front with PAXIL and on the back with 40. Oral SuspensionOrange‑colored, orange‑flavored, 10 mg/5 mL, in white bottles containing 250 mL. PAXIL is a registered trademark of GlaxoSmithKline. Manufactured by: GlaxoSmithKline, Research Triangle Park, NC 27709 Distributed by: Apotex Corp., Weston, FL 33326 |
| Drug | Countries | |
|---|---|---|
| PAXIL | Brazil, Canada, Ecuador, Japan, Mexico, Turkey, United States, South Africa |
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