PAROXETINE TABLETS USP

/PAROXETINE TABLETS USP
PAROXETINE TABLETS USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

PAROXETINE TABLETS USP

ID:

32fd11aa-2996-496d-ac3b-76a6afe22e3c

Code:

34391-3

DESCRIPTION


id: 025a248d-5e15-4e9c-bd7d-b13b569cde24
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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 and has the molecular formula of C19H20FNOHCl. The molecular weight is 365.8 (329.4 as free base). The structural formula is:

Structural formula

Paroxetine hydrochloride is an odorless, white to off-white powder, slightly soluble in water and soluble in methanol and in alcohol. Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg-white; 20 mg-white; 30 mg-white; 40 mg-white. Inactive ingredients consist of anhydrous dibasic calcium phosphate, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol 6000, povidone, sodium starch glycolate, talc, and titanium dioxide.

CONTRAINDICATIONS


id: 67537fb7-230f-40ed-8616-0b7db875ae83
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Concomitant use in patients taking either monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated (see WARNINGS and PRECAUTIONS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Paroxetine is contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in Paroxetine Tablets USP.

HOW SUPPLIED


id: 8cfea09b-d9ce-4352-9574-6e560759e27c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Paroxetine Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, film-coated tablets debossed with the logo of “ZC”, 15 and bisect on one side and plain on other side. 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. Paroxetine Tablets USP, 30 mg are white to off-white, round-shapped, biconvex, film-coated tablets debossed with the logo of “ZC17” on one side and plain on other side. Paroxetine Tablets USP, 40 mg are white to off-white, round-shapped, biconvex, film-coated tablets debossed with the logo of “ZC18” on one side and plain on other sid. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). MANUFACTURED BY: Cadila Healthcare Ltd. Ahmedabad, India Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA Original–08/2010–NJW Rev: 02/09

PRINCIPAL DISPLAY PANEL


id: 8942b390-d671-4f3b-8c28-dc15d9ef2bc1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

10 mg Tablets

PRINCIPAL DISPLAY PANEL


id: 777b0d15-8d07-443c-ad1b-fa423a35932d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

20 mg Tablets

PRINCIPAL DISPLAY PANEL


id: 469d0966-c477-4eab-b59f-05ca55208b43
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

30 mg Tablets

PRINCIPAL DISPLAY PANEL


id: d7392cae-842a-4b21-af5a-d03fb4b5291c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

40 mg Tablets