MedPath

Fluoxetine

Generic Name
Fluoxetine
Brand Names
Prozac, Sarafem, Symbyax
Drug Type
Small Molecule
Chemical Formula
C17H18F3NO
CAS Number
54910-89-3
Unique Ingredient Identifier
01K63SUP8D

Overview

Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.

Background

Fluoxetine is a 2nd generation antidepressant categorized as a selective serotonin reuptake inhibitor (SSRI). It gained FDA approval in 1987 and although it was initially intended for the treatment of depression, today it is commonly prescribed to manage depression in addition to various other pathologies.

Indication

Fluoxetine is indicated for both acute and maintenance treatment of major depressive disorder, obsessive compulsive disorder, and bulimia nervosa; however, it is only indicated for acute treatment of panic disorder independent of whether agoraphobia is present. Fluoxetine may also be used in combination with olanzapine to treat depression related to Bipolar I Disorder, and treatment resistant depression. Fluoxetine is additionally indicated for the treatment of female patients with premenstrual dysphoric disorder (PMDD).

Associated Conditions

  • Alcohol Dependency
  • Anorexia Nervosa (AN)
  • Bulimia Nervosa
  • Cataplexy
  • Depression
  • Major Depressive Disorder (MDD)
  • Major depressive disorder, recurrent episode
  • Myoclonus
  • Obesity
  • Obsessive Compulsive Disorder (OCD)
  • Panic Disorder With Agoraphobia
  • Panic disorder without agoraphobia
  • Premature Ejaculation
  • Premenstrual Dysphoric Disorder (PMDD)

FDA Approved Products

FLUOXETINE HYDROCHLORIDE
Manufacturer:DIRECT RX
Route:ORAL
Strength:10 mg in 1 1
Approved: 2015/11/02
NDC:61919-099
Fluoxetine
Manufacturer:RPK Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2022/04/30
NDC:53002-2305
Fluoxetine
Manufacturer:Rebel Distributors Corp
Route:ORAL
Strength:10 mg in 1 1
Approved: 2010/07/13
NDC:21695-052
Fluoxetine
Manufacturer:Rebel Distributors Corp
Route:ORAL
Strength:20 mg in 1 1
Approved: 2010/07/13
NDC:21695-053
Fluoxetine Hydrochloride
Manufacturer:ANI Pharmaceuticals, Inc.
Route:ORAL
Strength:20 mg in 5 mL
Approved: 2023/10/02
NDC:70954-600

Singapore Approved Products

No Singapore products found for this drug

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