FLUOXETINE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

McKesson Contract Packaging

INN (Rahvusvaheline Nimetus):

FLUOXETINE HYDROCHLORIDE

Koostis:

FLUOXETINE HYDROCHLORIDE 20 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

FLUOXETINE- FLUOXETINE CAPSULE
MCKESSON CONTRACT PACKAGING
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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.
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_
_OLANZAPINE AND FLUOXETINE HYDROCHLORIDE CAPSULES._
RECENT MAJOR CHANGES
INDICATIONS AND USAGE, fluoxetine and olanzapine in combination:
Depressive Episodes Associated with Bipolar I Disorder (1.5) 03/2009
DOSAGE AND ADMINISTRATION, fluoxetine and olanzapine in combination:
Depressive Episodes Associated with Bipolar I Disorder (2.5) 03/2009
WARNINGS AND PRECAUTIONS:
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like
Reactions (5.2) 01/2009
INDICATIONS AND USAGE
Fluoxetine is 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)
_Fluoxetine and olanzapine in combination_ for:
Acute treatment of Depressive Episodes Associated with Bipolar I
Disorder in adults (1.5)
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)