FLUOXETINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)

Available from:

Aidarex Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1) ]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see Dosage and Administration (2.1) ] . Fluoxetine capsules, USP are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ]. The effectiveness of fluoxetine capsules, USP in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine capsules, USP for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2) ]. Fluoxeti

Product summary:

Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880 Fluoxetine capsules, USP 40 mg * are green opaque cap with orange opaque body, hard gelatin #2 capsules filled with white to off-white powder, imprinted with “RX632” on the cap and body in black ink. They are available as follows: NDC 33261-0883-30 Bottles of 30 NDC 33261-0883-60 Bottles of 60 * Fluoxetine base equivalent – present as the hydrochloride. Protect from light. Dispense in a tight, light-resistant container. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aidarex Pharmaceuticals LLC
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MEDICATION GUIDE
Revised: 12/2017
Document Id: 868cf43c-6ce2-49d0-b94f-039efab76e9c
34391-3
Set id: eb231077-fa47-4469-b3c5-4e13d2365252
Version: 3
Effective Time: 20171222
Aidarex Pharmaceuticals LLC

Summary of Product characteristics

FLUOXETINE- FLUOXETINE CAPSULE
AIDAREX PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE CAPSULES, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE CAPSULES,
USP.
FLUOXETINE CAPSULES, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS (5.1).
MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS
(5.1).
_WHEN USING FLUOXETINE AND OLANZAPINE IN COMBINATION, ALSO REFER TO
BOXED WARNING SECTION OF THE PACKAGE INSERT FOR_
_OLANZAPINE AND FLUOXETINE HYDROCHLORIDE CAPSULES._
RECENT MAJOR CHANGES
BOXED WARNING:
Warnings: Suicidal Thoughts and Behaviors 07/2013
INDICATIONS AND USAGE:
Fluoxetine capsules, USP and Olanzapine in Combination: Depressive
Episodes Associated with
Bipolar I Disorder (1.5) 07/2013
DOSAGE AND ADMINISTRATION:
Fluoxetine capsules, USP and Olanzapine in Combination: Depressive
Episodes Associated with
Bipolar I Disorder (2.5) 07/2013
Dosing in Specific Populations (2.7) 07/2013
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI)
Intended to Treat Psychiatric Disorders (2.9)
01/2013
Use of fluoxetine with Other MAOIs such as Linezolid or Methylene Blue
(2.10) 01/2013
CO NTRAINDIC ATIO NS:
Monoamine Oxidase Inhibitors (MAOIs) (4.1) 01/2013
Other Contraindications (4.2) 07/2013
WARNINGS AND PRECAUTIONS:
Clinical Worsening and Suicide Risk (5.1) 07/2013
Serotonin Syndrome (5.2) 01/2013
QT Prolongation (5.10) 07/2013
INDICATIONS AND USAGE
Fluoxetine capsules, USP is a selective serotonin reuptake inhibitor
indicated for: (1)
Acute and maintenance treatment of Major Depressive Disorder (MDD) in
adult and pediatric patients aged 8 to 18
years (1.1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
in adult and pediatric patie