Fluoxetine 10 mg Capsules — Generic For Prozac — Modavar

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.

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 capsules are a selective serotonin reuptake inhibitor indicated for:

Fluoxetine capsules and olanzapine in combination for treatment of:

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 Episode s 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 (initial dose)

Fluoxetine capsules and olanzapine in combination:

Dosage Forms And Strengths

Contraindications

Warnings And Precautions

• (5.2, 5.7) 8/2023 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)
• 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 Episode s 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 (initial dose)
• A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (2.7) Fluoxetine capsules and olanzapine in combination:

• (5.2, 5.7) 8/2023 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)
• 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 Episode s 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 (initial dose)
• A lower or less frequent dosage should be used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications (2.7) Fluoxetine capsules and olanzapine in combination:

Adverse Reactions

Most common adverse reactions (≥5% and at least twice that for placebo) associated with:

Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia, and Panic Disorder: abnormal dreams, abnormal ejaculation, anorexia, anxiety, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, impotence, insomnia, libido decreased, nausea, nervousness, pharyngitis, rash, sinusitis, somnolence, sweating, tremor, vasodilatation, and yawn (6.1)

Fluoxetine and olanzapine in combination -Also refer to the Adverse Reactions section of the package insert for Symbyax (6)

To report SUSPECTED ADVERSE REACTIONS, contact Modavar Pharmaceuticals LLC at Toll free number: 800 688 4697 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

Use In Specific Populations

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2024