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:

RedPharm Drug, Inc.

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. 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). Fluoxetine capsules monotherapy is not indicated for the treatment of depressive episodes associated with

Product summary:

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 30                             NDC 65862-192-30             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 30                             NDC 65862-193-30             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. 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 HYDROCHLORIDE 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 health

Summary of Product characteristics

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
REDPHARM DRUG, INC.
----------
FLUOXETINE 10MG
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._
1 INDICATIONS AND USAGE
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.
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).
Fluoxetine capsules m