Complete SPL Sections
Suicidality and Antidepressant Drugs
BOXED WARNING SECTION
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 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 are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk , PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use ).
DESCRIPTION
DESCRIPTION SECTION
Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- trans -4 R -(4'-fluorophenyl)-3 S -[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C 19 H 20 FNO 3 •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°C 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.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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.
WARNINGS
WARNINGS SECTION
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
DRUG ABUSE AND DEPENDENCE
DRUG ABUSE AND DEPENDENCE SECTION
OVERDOSAGE
OVERDOSAGE SECTION
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
HOW SUPPLIED
HOW SUPPLIED SECTION
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 60429-734-30 Bottles of 30; NDC 60429-734-90 Bottles of 90; NDC 60429-734-10 Bottles of 1000. 20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side. NDC 60429-735-30 Bottles of 30; NDC 60429-735-90 Bottles of 90; NDC 60429-735-10 Bottles of 1000. 30 mg unscored tablets imprinted “APO” on one side and “084” on the other side. NDC 60429-736-30 Bottles of 30; NDC 60429-736-90 Bottles of 90; NDC 60429-736-10 Bottles of 1000. 40 mg unscored tablets imprinted “APO” on one side and “101” on the other side. NDC 60429-737-30 Bottles of 30; NDC 60429-737-90 Bottles of 90; NDC 60429-737-10 Bottles of 1000. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F 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, Florida Canada M9L 1T9 33326 Marketed/Packaged by: GSMS, Inc. Camarillo, CA 93012 USA Revised: January 2017 Rev. 12
MEDICATION GUIDE
SPL MEDGUIDE SECTION
Repackaging Information
SPL UNCLASSIFIED SECTION
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 10 mg 90 71610-348-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20191011JH
PRINCIPAL DISPLAY PANEL - 10 mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 71610-348 - Paroxetine, USP 10 mg Tablets - Rx Only