FLUOXETINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE 10 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)]. When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. The use of MAOIs intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. The use of fluoxeti

Product summary:

Fluoxetine tablets USP, 10 mg are available as blue, oval shaped, film-coated tablets, plain on one side and debossed “7188” and scored on the other side and debossed “9” (scoring) “3”. They are available in bottles of 30 (NDC 0093-7188-56), 100 (NDC 0093-7188-01), and 1000 (NDC 0093-7188-10). Fluoxetine tablets USP, 20 mg are available as white, oval shaped, film-coated tablets, debossed with “TEVA” on one side and scored on the other side and debossed with “08” (scoring) “07”. They are available in bottles of 30 (NDC 0093-0807-56), and 100 (NDC 0093-0807-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUOXETINE- FLUOXETINE TABLET, FILM COATED
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Fluoxetine (floo-ox´-e-teen) Tablets
Read the Medication Guide that comes with fluoxetine tablets 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
tablets?
Fluoxetine tablets and other antidepressant medicines may cause
serious side effects, including:
1. Suicidal thoughts or actions:
•
Fluoxetine tablets 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 tablets 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

Summary of Product characteristics

FLUOXETINE- FLUOXETINE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOXETINE TABLETS.
FLUOXETINE TABLETS, 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, Sexual Dysfunction (5.17) 6/2021
INDICATIONS AND USAGE
Fluoxetine is 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)
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)
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for
patients with concurrent disease or on multiple concomitant
medications (2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg and 20 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with
fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do
not use fluoxetine within 14 days
of stopping an MAOI intended to treat psychiatric disorders. In
addition, do not start fluoxetine i