FLUOXETINE- fluoxetine hydrochloride capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

AvKARE, Inc.

Designación común internacional (DCI):

FLUOXETINE HYDROCHLORIDE

Composición:

FLUOXETINE 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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)]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: - Acute treatment of depressive episodes associated with Bipolar I Disorder. Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. 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 Contrai

Resumen del producto:

Fluoxetine Capsules, USP is manufactured by Par Pharmaceutical Companies, Inc. The 40mg 1 capsule is a light blue opaque cap and opaque white body, imprinted with “872” on the cap and “par” on the body. NDC 42291-291-90  Bottles of 90 1 Fluoxetine base equivalent. Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F). Protect from light.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
AvKARE, Inc.
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
(floo-OX-e-teen)
Read the Medication Guide that comes with Fluoxetine before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
doctor about your medical condition or treatment. Talk with your
healthcare provider if there is
something you do not understand or you want to learn more about
Fluoxetine.
What is the most important information I should know about Fluoxetine
Capsules, USP?
Fluoxetine and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Fluoxetine 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 is 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 a 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:
•
attempt 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 irittable
•
trouble sleeping
•
an increase in activity or talking more than what is normal for you
•
other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?

Ficha técnica

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
FLUOXETINE CAPSULES, USP
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR FLUOXETINE. 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 OF THE INSERT FOR FLUOXETINE HYDROCHLORIDE AND OLANZAPINE
CAPSULES.
RECENT MAJOR CHANGES
Warnings and Precautions:
Angle-Closure Glaucoma (5.8) 07/2014
INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
(1)
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 in adult patients
(1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)
_Fluoxetine and olanzapine in combination for_: (1)
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
ADULT
PE DIATRIC
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)
-
De pre ssive
Episode s
Associate d
with Bipolar I
Disorder (2.5)
Oral in combination with olanzapine: 5 mg of oral
olanzapine and 20 mg of fluoxetine once daily (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 o