Description
id: 65e7f1eb-0d26-d0a7-e053-2a91aa0a23d8
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Paroxetine tablets, USP are 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 molecular formula of C
19H
20FNO
3•HCl•1/2H
2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride hemihydrate is:
Paroxetine hydrochloride, USP is an odorless, white to off-white crystalline powder, having a melting point range of 120° to 138°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in dichloromethane and slightly soluble in water.
Each paroxetine tablet, USP intended for oral administration contains paroxetine hydrochloride hemihydrate equivalent to 10 mg or 20 mg or 30 mg or 40 mg of paroxetine. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.
Metabolism and Excretion:
id: 65e7f1eb-0d28-d0a7-e053-2a91aa0a23d8
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
The mean elimination half-life is approximately 21 hours (CV 32%) after oral dosing of paroxetine tablets, 30 mg tablets daily for 30 days. In steady-state dose proportionality studies involving elderly and nonelderly patients, at doses of 20 mg to 40 mg daily for the elderly and 20 mg to 50 mg daily for the nonelderly, some nonlinearity was observed in both populations, again reflecting a saturable metabolic pathway. In comparison to C
min values after 20 mg daily, values after 40 mg daily were only about 2 to 3 times greater than doubled.
Paroxetine is extensively metabolized after oral administration. The principal metabolites are polar and conjugated products of oxidation and methylation, which are readily cleared. Conjugates with glucuronic acid and sulfate predominate, and major metabolites have been isolated and identified. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The metabolism of paroxetine is accomplished in part by CYP2D6. Saturation of this enzyme at clinical doses appears to account for the nonlinearity of paroxetine kinetics with increasing dose and increasing duration of treatment. The role of this enzyme in paroxetine metabolism also suggests potential drug-drug interactions (see PRECAUTIONS: Drugs Metabolized by CYP2D6).
Approximately 64% of a 30-mg oral solution dose of paroxetine was excreted in the urine with 2% as the parent compound and 62% as metabolites over a 10-day post-dosing period. About 36% was excreted in the feces (probably via the bile), mostly as metabolites and less than 1% as the parent compound over the 10-day post-dosing period.
Social Anxiety Disorder
id: 65e7f1eb-0d31-d0a7-e053-2a91aa0a23d8
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Paroxetine tablets, USP are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person’s normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.The efficacy of paroxetine tablets, USP were established in three 12-week trials in adult patients with social anxiety disorder (DSM-IV). Paroxetine tablets, USP have not been studied in children or adolescents with social phobia (see CLINICAL PHARMACOLOGY — Clinical Trials).
The effectiveness of paroxetine tablets, USP in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe paroxetine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
HOW SUPPLIED
id: 65e8042b-7bcb-ca81-e053-2a91aa0afdae
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Paroxetine Tablets USP, 20 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of ‘ZC, 16 and bisect’ on one side and plain on other side, and are supplied as follows:
NDC 60760-098-90 BOTTLES OF 90
Paroxetine Tablets USP, 40 mg are white to off-white, round-shaped, biconvex, film- coated tablets debossed with the logo of ‘ZC18’ on one side and plain on other side, and are supplied as follows:
NDC 60760-099-90 BOTTLES OF 90
