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:

ReadyMeds

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 20 mg

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)]. F

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 100                           NDC 65862-192-01             Bottles of 500                           NDC 65862-192-05             Bottles of 1000                         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 1000                         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 1000                         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
ReadyMeds
----------
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 provi

Summary of Product characteristics

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
READYMEDS
----------
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_
_SYMBYAX._
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 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 Capsules 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 are a selective serotonin reuptake inhibitor
indicated for:
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 patients aged 7 to 17
years (1.2)
Acute and mai