FLUOXETINE- fluoxetine capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

REMEDYREPACK INC.

INN (Internationale Bezeichnung):

FLUOXETINE HYDROCHLORIDE

Zusammensetzung:

FLUOXETINE 20 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 capsules and olanzap

Produktbesonderheiten:

Fluoxetine capsules, USP 10 mg ** are white to off white powder filled in size "4" hard gelatin capsules with opaque light blue colored cap and opaque light orange colored body imprinted "SG" on cap and "113" on body with black ink. Bottles of 30                           NDC 31722-903-30 Bottles of 100                         NDC 31722-903-01 Bottles of 500                         NDC 31722-903-05 Bottles of 1000                       NDC 31722-903-10     Fluoxetine Capsules USP, 20 mg ** are white to off white powder filled in size "2"hard gelatin capsules with opaque light blue colored cap and opaque light green colored body imprinted "SG"on cap and "114" on body with black ink. Bottles of 30                           NDC 31722-904-30 Bottles of 100                         NDC 31722-904-01 Bottles of 500                         NDC 31722-904-05 Bottles of 1000                       NDC 31722-904-10  Fluoxetine Capsules USP, 40 mg ** are white to off white powder filled in size "0" hard gelatin capsules with opaque light blue colored cap and opaque white colored body imprinted "SG" on cap and "115" on body with black ink. Bottles of 30                             NDC 31722-905-30 Bottles of 100                           NDC 31722-905-01 Bottles of 500                           NDC 31722-905-05 ** Fluoxetine base equivalent. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

REMEDYREPACK INC.
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Revised: 3/2019
Document Id: 835cb606-a031-305b-e053-2a91aa0a8164
34391-3
Set id: 46b85b8f-c9cd-4599-a0ed-b7bff1e610fd
Version: 4
Effective Time: 20190305
REMEDYREPACK INC.

Fachinformation

FLUOXETINE- FLUOXETINE CAPSULE
REMEDYREPACK INC.
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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 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 and olanzapine in combination for treatment of:_
• Acute Depressive Episodes Associated with Bipolar I Disorder ( 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)
A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for