Suicidality and Antidepressant Drugs
id: a503f8cf-8d92-65a8-48a7-b8e0b2ef6dc0
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: 2adba8d6-1df8-fd87-c7b7-200412fff670
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.
CLINICAL PHARMACOLOGY
id: 84241fe4-5bac-99f8-865f-ac2631d8529c
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
INDICATIONS AND USAGE
id: edb65c38-87dc-5ac8-8b4b-9b69766363b8
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
CONTRAINDICATIONS
id: a75af777-d844-6478-c580-462111e37cb5
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
The use of MAOIs intended to treat depression with, or within 14 days of treatment with, paroxetine tablets is contraindicated (see
WARNINGS
).
Do not start paroxetine tablets in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see
WARNINGS
).
Concomitant use with 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.
WARNINGS
id: c9577b56-a229-8add-39a5-b4f14ebffd10
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
PRECAUTIONS
id: 8b81583c-03de-4220-f3d2-6e913e3a0c0d
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
ADVERSE REACTIONS
id: 3c1344fc-0d0d-9f89-cfe3-34be5b0ed93c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
DRUG ABUSE AND DEPENDENCE
id: a82f3695-8a3a-b58c-752b-cc8445a01c57
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
OVERDOSAGE
id: 5c95a32a-3a60-ff25-07af-9d43cdeb2c3f
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
id: 3fca2cdb-13f8-5a60-8f14-089f935d81f9
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
HOW SUPPLIED
id: 81f1c936-a99f-4837-8ad7-2c092720dd84
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.
| Bottles of 30
|
NDC 54868-5080-0
|
| Bottles of 90
|
NDC 54868-5080-1
|
20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side.
| Bottles of 30
|
NDC 54868-4937-0
|
| Bottles of 60
|
NDC 54868-4937-3
|
| Bottles of 90
|
NDC 54868-4937-1
|
| Bottles of 100
|
NDC 54868-4937-4
|
30 mg unscored tablets imprinted “APO” on one side and “084” on the other side.
| Bottles of 30
|
NDC 54868-4938-0
|
| Bottles of 90
|
NDC 54868-4938-1
|
40 mg unscored tablets imprinted “APO” on one side and “101” on the other side.
| Bottles of 30
|
NDC 54868-4817-0
|
| Bottles of 60
|
NDC 54868-4817-1
|
| Bottle sof 90
|
NDC 54868-4817-2
|
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
|
Rev. 9
Revised: September 2011
Distributed and Repackaged by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
MEDICATION GUIDE
id: e6db52bf-36e5-d6b4-ac23-d765ca3e2f72
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
PRINCIPAL DISPLAY PANEL
id: 6f162aa1-8e6a-4fb2-81c1-46b1c8f38ca8
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Representative sample of the labeling (see the
HOW SUPPLIED
section for complete listing):
PRINCIPAL DISPLAY PANEL – 10 mg BOTTLE LABEL
PAROXETINE TABLETS, USP
10 mg
Rx
PRINCIPAL DISPLAY PANEL
id: da3a3754-ff27-4bf0-a2b7-01ec2370ec49
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Representative sample of the labeling (see the
HOW SUPPLIED
section for complete listing):
PRINCIPAL DISPLAY PANEL – 20 mg BOTTLE LABEL
PAROXETINE TABLETS, USP
20 mg
Rx
PRINCIPAL DISPLAY PANEL
id: ddf98060-f4fa-4c71-83d6-bee04da2c294
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Representative sample of the labeling (see the
HOW SUPPLIED
section for complete listing):
PRINCIPAL DISPLAY PANEL – 30 mg BOTTLE LABEL
PAROXETINE TABLETS, USP
30 mg
Rx
PRINCIPAL DISPLAY PANEL
id: 5b638611-1ca2-493f-8189-5f413e49948b
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Representative sample of the labeling (see the
HOW SUPPLIED
section for complete listing):
PRINCIPAL DISPLAY PANEL – 40 mg BOTTLE LABEL
PAROXETINE TABLETS, USP
40 mg
Rx
