FLUOXETINE- fluoxetine hydrochloride capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

PD-Rx Pharmaceuticals, Inc.

INN (International ime):

FLUOXETINE HYDROCHLORIDE

Sastav:

FLUOXETINE 20 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fluoxetine capsules, USP 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, USP and Olanzapine in Combination is 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

Proizvod sažetak:

Fluoxetine capsules, USP, 20 mg are available as: 20 mg: white capsules, imprinted GG 550 with green and black ink bands, filled with white powder and supplied as: NDC 55289-610-14 bottles of 14 NDC 55289-610-28 bottles of 28 NDC 55289-610-30 bottles of 30 NDC 55289-610-60 bottles of 60 NDC 55289-610-90 bottles of 90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

FLUOXETINE- fluoxetine hydrochloride capsule
PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Fluoxetine Capsules, USP
(floo ox' e teen)
Read the Medication Guide that comes with fluoxetine capsules 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
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

Svojstava lijeka

FLUOXETINE- FLUOXETINE HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOXETINE CAPSULES.
FLUOXETINE CAPSULES 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_.
INDICATIONS AND USAGE
Fluoxetine capsules, USP are 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)
_Fluoxetine capsules, USP and olanzapine in combination for treatment
of:_
Acute Depressive Episodes Associated with Bipolar I Disorder ( 1)
Treatment Resistant Depression ( 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)
–
Depressive Episodes
Associated 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)
Oral in combination with
olanzapine: 2.5 mg of oral
olanzapine and 20 mg of
fluoxetine once daily (initial
dose)
Treatment Resistant
Depression ( 2.6)
Oral in combination with olanzapine: 5 mg of
oral olanzapine and 20 mg of fluoxetine once
daily