Suicidality and Antidepressant Drugs
id: d1ff72df-6d09-436d-89ed-dcc78b2234be
displayName: Boxed Warning section
FDA Article Code: 34066-1
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine tablets, USP or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine tablets, USP are not approved for use in pediatric patients. (See WARNINGS,
Clinical Worsening and Suicide Risk, PRECAUTIONS,
Information for Patients, and PRECAUTIONS,
Pediatric Use.)
DESCRIPTION
id: e9dfd343-3067-4e9d-ad92-e5b9185a9123
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 anhydrous and has the empirical formula of C19H20FNO3•HCl. The molecular weight is 365.8 (anhydrous) (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 116° to 120°C and a solubility of 5.4 mg/mL in water.
Each film-coated tablet, for oral administration, contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg; 20 mg; 30 mg; 40 mg. Inactive ingredients consist of anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide. Paroxetine tablets comply with USP Related Impurities Test 1.
CONTRAINDICATIONS
id: c6256628-cf5a-442c-b5b7-0cba7a7e2cdd
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 within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see
WARNINGS
and
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
WARNINGS
and
DOSAGE AND ADMINISTRATION).
Concomitant use with thioridazine is contraindicated (see
WARNINGS
and
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: 2cc6ae12-7ed1-4ae4-89f7-9e769bdbb7c7
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Paroxetine tablets, USP are supplied as white to off-white, oval, film-coated tablets as follows:
10 mg scored tablets imprinted “APO” with a partial bisect on one side and “097” on the other side.; NDC 0904-5676-61 Unit dose blisters, package of 100
20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. NDC 0904-5677-61 Unit dose blisters, package of 100
30 mg unscored tablets imprinted “APO” on one side and “084” on the other side. NDC 0904-5678-61 Unit dose blisters, package of 100
40 mg unscored tablets imprinted “APO” on one side and “101” on the other side. NDC 0904-5679-61 Unit dose blisters, package of 100
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container [see USP].
APOTEX INC.
PAROXETINE TABLETS, USP
10 mg, 20 mg, 30 mg and 40 mg
Manufactured by Manufactured for
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston,
Canada Florida
M9L 1T9 33326
Distributed By:
MAJOR® PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150
Revised: August 2014
Rev. 11
Package/Label Display Panel
id: 45164679-4269-464e-9639-f5998f2c8a9a
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Paroxetine Tablets, USP
10 mg.
100 Tablets
Package/Label Display Panel
id: 7fea695d-0d99-4754-9d9f-909d6f408b05
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Paroxetine Tablets, USP
20 mg
100 Tablets
Package/Label Display Panel
id: 82cfce69-fe48-40c9-9108-004798ac7c47
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Paroxetine Tablets, USP
30 mg
100 Tablets
Package/Label Display Panel
id: ac961c29-af7d-43da-a114-3975172b93c7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Paroxetine Tablets, USP
40 mg
100 Tablets
