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:

Unit Dose Services

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluoxetine capsules are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated . [see ]. Clinical Studies (14.1) [see ] Dosage and Administration (2.1) Fluoxetine capsules 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) The effectiveness of fluoxetine capsules 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 for extended periods, should periodically re-evaluate the long-term usefulness of the drug for t

Product summary:

NDC:50436-0924-1 in a BOTTLE of 30 CAPSULES 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 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 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. Fluoxetine Capsules USP, 10 mg* Fluoxetine Capsules USP, 20 mg* Fluoxetine Capsules USP, 40 mg* 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. Store at

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE
Unit Dose Services
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MEDICATION GUIDE
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. Fluoxetine capsules and
other antidepressant medicines may cause serious side effects,
including: Fluoxetine Capsules, USP
What is the most important information I should know about fluoxetine
capsules?
1. Suicidal thoughts or actions:
•
in some children, teenagers, or young adults within the Fluoxetine
capsulesand other
antidepressant medicines may increase suicidal thoughts or
actionsfirst 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

Summary of Product characteristics

FLUOXETINE - FLUOXETINE HYDROCHLORIDE CAPSULE
UNIT DOSE SERVICES
----------
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: SUICIDALITY AND ANTIDEPRESSANT DRUGS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG ADULTS TAKING
ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER
PSYCHIATRIC DISORDERS . (5.1)
_WHEN USING FLUOXETINE AND OLANZAPINE IN COMBINATION, ALSO REFER TO
BOXED WARNING SECTION OF THE PACKAGE INSERT FOR_
_SYMBYAX._
RECENT MAJOR CHANGES
Dosage and Administration:
Switching a Patient To or From a Monoamine Oxidase
Inhibitor (MAOI) Intended to Treat Psychiatric Disorders 01/2013 (2.9)
Use of Fluoxetine Capsules with Other MAOIs such as Linezolid
or Methylene Blue 01/2013 (2.10)
Contraindications:
Monoamine Oxidase Inhibitors (MAOIs) 01/2013 (4.1)
Other Contraindications 01/2013 (4.2)
Warnings and Precautions:
Dosing in Specific Populations 01/2013 (2.7)
Serotonin Syndrome 01/2013 (5.2)
INDICATIONS AND USAGE
Fluoxetine capsules 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 maintenance treatment of Bulimia Nervosa in adult patients
(1.3)
Acute treatment of Panic Disorder, with or without agoraphobia, in
adult patients (1.4)
for: _Fluoxetine capsules and olanzapine in combination_
Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1.5)
DOSAGE AND ADMINISTRATION
INDICATION
ADULT
PEDIATRIC
MDD (2.1)
20 mg/day in am (initial dose)
10 to 20 mg/day
(initial do