DESCRIPTION
id: 0ca6c880-ca3c-400e-8d9f-08c016873b9e
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 – -(4′ fluorophenyl)- -[(3′,4′-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the molecular formula of C H FNO •HCl•1/2H O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride hemihydrate is:
(-)-trans
4R
–
3S
19
20
3
2
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.
CONTRAINDICATIONS
id: 8829b4ca-f9bf-454a-8f28-d02b9ca1d4b7
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
The use of MAOIs intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).
WARNINGS
DOSAGE AND ADMINISTRATION
Starting paroxetine tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see and ).
WARNINGS
DOSAGE AND ADMINISTRATION
Concomitant use with thioridazine is contraindicated (see and ).
WARNINGS
PRECAUTIONS
Concomitant use in patients taking pimozide is contraindicated (see ).
PRECAUTIONS
Paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets.
HOW SUPPLIED
id: e554e589-2a53-4f2e-b1b3-6feec987e164
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
NDC:64725-0098-1 in a BOTTLE of 90 TABLET, FILM COATEDS
PAROXETINE TABLET, FILM COATED
id: c809c0e7-7e40-4ab4-a099-091d6012347c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
