FLUOXETINE- fluoxetine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, 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. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax® . When using fluoxetine capsules and olanzapine in co

Product summary:

Fluoxetine Capsules USP, 40 mg** are white to off white powder filled in size "0" hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted "SG" on cap and "115" on body with black ink. Bottles of 30                             NDC 68788-6790-3 Bottles of 60                             NDC 68788-6790-6 Bottles of 90                             NDC 68788-6790-9 ** Fluoxetine base equivalent. 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE CAPSULE
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Medication Guide
Fluoxetine Capsules, USP
(floo-ox-e-teen)
Read the Medication Guide that comes with fluoxetine capsules 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
healthcare provider about your medical condition or treatment. Talk
with your healthcare provider if there is
something you do not understand or want to learn more about.
What is the most important information I should know about fluoxetine
capsules?
Fluoxetine capsules and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
• Fluoxetine capsules and other antidepressant medicines may
increase suicidal thoughts or actions in some
children, teenagers, or young adults within the first few months
oftreatment 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 capsules
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 your 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:
• attempts 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 irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for
you
• other unusual changes in behavior or mood
Call y

Summary of Product characteristics

FLUOXETINE- FLUOXETINE CAPSULE
PREFERRED PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE CAPSULES, SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOXETINE CAPSULES.
FLUOXETINE CAPSULES, 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_
_SYMBYAX_.
RECENT MAJOR CHANGES
Warnings and Precautions: Serotonin Syndrome (5.2) 01/2017
INDICATIONS AND USAGE
Fluoxetine capsules are 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 (1)
• Acute treatment of Panic Disorder, with or without agoraphobia (1)
_Fluoxetine capsules and olanzapine in combination for treatment of:_
• Acute Depressive Episodes Associated with Bipolar I Disorder (1)
DOSAGE AND ADMINISTRATION
INDICATION
ADULT
PEDIATRIC
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)
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and f