FLUOXETINE- fluoxetine capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Micro Labs Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. - Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). Fluoxetine monotherapy is not indicated for the treatment of d

Product summary:

Fluoxetine Capsules USP 1,2 , 10 mg are available as Size '4' Green opaque cap imprinted with 'FL' and Green opaque body imprinted with '10' hard gelatin capsules containing white to off-white coloured granular powder. Bottles of 30                           NDC 42571-387-30 Bottles of 100                         NDC 42571-387-01 Bottles of 1000                       NDC 42571-387-10 Fluoxetine Capsules USP 1,2 , 20 mg are available as Size '3' Green opaque cap imprinted with 'FL' and Ivory opaque body imprinted with '20' hard gelatin capsules containing white to off-white coloured granular powder. Bottles of 30                           NDC 42571-388-30 Bottles of 100                         NDC 42571-388-01 Bottles of 1000                       NDC 42571-388-10 Fluoxetine Capsules USP 1,2 , 40 mg are available as Size '1' Green opaque cap imprinted with 'FL' and Orange opaque body imprinted with '40' hard gelatin capsules containing white to off-white coloured granular powder. Bottles of 30                           NDC 42571-389-30 Bottles of 100                         NDC 42571-389-01 Bottles of 1000                       NDC 42571-389-10 1 Fluoxetine base equivalent. 2 Protect from light. 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOXETINE - FLUOXETINE CAPSULE
MICRO LABS LIMITED
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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 ( 5.2, 5.7) 8/2023
INDICATIONS AND USAGE
Fluoxetine is 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 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