FLUOXETINE- fluoxetine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine is indicated for the treatment of: - Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)]. - Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2 )]. - Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ]. - Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4) ]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: - Acute treatment of depressive episodes associated with Bipolar I Disorder. - Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antid

Product summary:

Fluoxetine Capsules, USP is manufactured by Par Pharmaceutical. The 40mg 1 capsule is a light blue opaque cap and opaque white body, imprinted with “872” on the cap and “par” on the body. NDC 49884-872-11 - Bottle of 30 NDC 49884-872-01 - Bottle of 100 NDC 49884-872-05 - Bottle of 500 1 Fluoxetine base equivalent. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F). Protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
(floo-OX-e-teen)
Read the Medication Guide that comes with fluoxetine before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
doctor about your medical condition or treatment. Talk with your
healthcare provider if there is
something you do not understand or you want to learn more about
Fluoxetine.
What is the most important information I should know about Fluoxetine
Capsules, USP?
Fluoxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Fluoxetine and other antidepressant medicines may increase suicidal
thoughts or actions in some
children, teenagers, or young adults within the first few months of
treatment or when the dose is
changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if
severe.
•
Pay particular attention to such changes when fluoxetine is started or
when the dose is
changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call a healthcare provider right away if you have any of the following
symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempt to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or worse anxiety or panic attacks
•
feeling agitated, restless, angry, or irittable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
What else do I need to know about antidepressan

Summary of Product characteristics

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLUOXETINE. 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 OF THE INSERT FOR FLUOXETINE HYDROCHLORIDE AND OLANZAPINE
CAPSULES.
RECENT MAJOR CHANGES
Warnings and Precautions:
Serotonin Syndrome (5.2) 01/2017
INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
(1)
Acute and maintenance treatment of Bulimia Nervosa in adult patients
(1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
_Fluoxetine and olanzapine in combination for_:
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
Treatment Resistant Depression (1)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
ADULT
PE DIATRIC
MDD (2.1)
20 mg/day in am (initial dose)
10 to 20 mg/day (initial dose)
OCD (2.2)
20 mg/day in am (initial dose)
10 mg/day (initial dose)
Bulimia Nervosa (2.3)
60 mg/day in am
-
Panic Disorder (2.4)
10 mg/day (initial dose)
-
Depressive Episodes
Associated with Bipolar I
Disorder (2.5)
Oral in combination with olanzapine: 5 mg of
oral olanzapine and 20 mg of fluoxetine once
daily (initial dose)
Oral in combination with olanzapine: 2.5 mg of
oral olanzapine and 20 mg of fluoxetine once
daily (initial dose)
Treatment Resistant
Depression (2.6)
Oral in combination with ol