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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (P's) » Paroxetine



DESCRIPTION

Paroxetine HCl is an orally administered antidepressant with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic or other available antidepressant agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (Immediate-Release Tablets and Oral Suspension:) (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and (Controlled-Release Tablets:) (-) - (3S,4R)-4-[(p-fluorophenyl)-3-[(3,4-methylenedioxy) phenoxy]methyl]piperidine hydrochloride hemihydrate.

The empirical formula is C19H20FNO3HCl½H2O. The molecular weight is 374.8 (329.4 as free base).

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

Immediate-Release Tablets: Each film-coated Paxil tablet contains paroxetine HCl equivalent to paroxetine as follows: 10 mg: Yellow; 20 mg: Pink (scored); 30 mg: Blue, 40 mg: Green. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide and one 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.

Oral Suspension: Each 5 ml of Paxil orange-colored, orange-flavored liquid contains paroxetine HCl 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.

Controlled-Release Tablets: Each enteric, film-coated, bilayer, controlled-release Paxil tablet contains paroxetine HCl equivalent to paroxetine as follows: 12.5 mg and 25 mg. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix. The barrier layer is pale yellow and pink for the 12.5 mg and 25 mg strength tablets, respectively; the active layer is white.

Inactive ingredients consist of hydroxypropyl methylcellulose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, colloidal silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, and one or more of the following colorants: yellow ferric oxide, red ferric oxide.

CATEGORIES, BRAND NAMES

CATEGORIES: Anxiety, panic disorder; Anxiety, social; Depression; Obsessive-compulsive disorder; Pregnancy Category B; FDA Class 1S ("Standard Review"); FDA Approved 1992 Dec; Top 200 Drugs

FDA Drug Classes: Antidepressants

BRAND NAMES:

BRAND NAMES: Aropax 20; Deroxat; Paroxet; Paxil; Seroxat; Tagonis
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Aropax 20 (Australia; Mexico; New-Zealand)
Deroxat (France)
Paroxet (Peru)
Tagonis (Germany)

COST OF THERAPY: $218.70 (Depression; Paxil Tablet; 20 mg; 1/day; 90 days)





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