FLUOXETINE HYDROCHLORIDE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Avera McKennan Hospital

INN (Nome Internazionale):

FLUOXETINE HYDROCHLORIDE

Composizione:

FLUOXETINE 40 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUOXETINE HYDROCHLORIDE- FLUOXETINE HYDROCHLORIDE CAPSULE
AVERA MCKENNAN HOSPITAL
----------
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_.
RECENT MAJOR CHANGES
Warnings and Precautions:
Serotonin Syndrome (5.2)
01/2017
INDICATIONS AND USAGE
Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor
indicated for:
1.
2.
3.
4.
_Fluoxetine capsules USP and olanzapine in combination for treatment
of:_
5.
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)
–
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)
1.
_Fluoxetine and olanzapine in combination_:
1.
2.
3.
4.
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)
Acute Depressive Episodes Associated with Bipolar I Disorder (1)
A lower or less f