FLUOXETINE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

16.1 How Supplied Fluoxetine Capsules USP, 10 mg* are opaque green cap/opaque green body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘88’ on opaque green body with black ink. Bottles of 100 NDC 65862-192-01 Bottles of 500 NDC 65862-192-05 Bottles of 1,000 NDC 65862-192-99 Fluoxetine Capsules USP, 20 mg* are opaque green cap/opaque off white body, size ‘3’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘91’ on opaque off white body with black ink. Bottles of 100 NDC 65862-193-01 Bottles of 500 NDC 65862-193-05 Bottles of 1,000 NDC 65862-193-99 Fluoxetine Capsules USP, 40 mg* are opaque green cap/opaque orange body, size ‘2’ hard gelatin capsule filled with white to off-white granular powder and imprinted with ‘E’ on opaque green cap and ‘92’ on opaque orange body with black ink. Bottles of 30 NDC 65862-194-30 Bottles of 100 NDC 65862-194-01 Bottles of 500 NDC 65862-194-05 Bottles of 1,000 NDC 65862-194-99 *Fluoxetine base equivalent. 16.2 Storage and Handling 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]. Preserve in tight, light-resistant containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE CAPSULE
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
(floo ox' e teen)
Read the Medication Guide that comes with fluoxetine capsules before
you start taking them 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 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 capsules are
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 your healthcare provider right away if you have any of the
following symptoms, or cal

Summary of Product characteristics

FLUOXETINE- FLUOXETINE CAPSULE
REDPHARM DRUG, INC.
----------
BOXED WARNING
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior
in children,
adolescents, and young adults in short-term studies. These studies did
not show
an increase in the risk of suicidal thoughts and behavior with
antidepressant use in
patients over age 24; there was a reduction in risk with
antidepressant use in
patients aged 65 and older [see WARNINGS AND PRECAUTIONS (5.1)].
In patients of all ages who are started on antidepressant therapy,
monitor closely
for worsening and for emergence of suicidal thoughts and behaviors.
Advise
families and caregivers of the need for close observation and
communication with
the prescriber [see WARNINGS AND PRECAUTIONS (5.1)].
Fluoxetine is not approved for use in children less than 7 years of
age [see
WARNINGS AND PRECAUTIONS (5.1) and USE IN SPECIFIC POPULATIONS (8.4)].
When using fluoxetine and olanzapine in combination, also refer to
Boxed Warning
section of the package insert for Symbyax.
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 treatme