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Fluoxetine

Brand and Other Names: PROZAC
Mechanism of Action:

Although the exact mechanism of PROZAC is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

Indications:

PROZAC is a selective serotonin reuptake inhibitor indicated for:

  • Acute and maintenance treatment of Major Depressive Disorder (MDD)
  • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD)
  • Acute and maintenance treatment of Bulimia Nervosa
  • Acute treatment of Panic Disorder, with or without agoraphobia

PROZAC and olanzapine in combination for treatment of:

  • Acute Depressive Episodes Associated with Bipolar I Disorder
  • Treatment Resistant Depression
Route: Oral
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.
  • PROZAC and olanzapine in combination:
  • Dosage adjustments should be made with the individual components according to efficacy and tolerability.
  • Fluoxetine monotherapy is not indicated for the treatment of Depressive Episodes associated with Bipolar I Disorder or treatment resistant depression.
  • Safety of the coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults.
  • Safety of the coadministration of doses above 12 mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17.

See package insert for complete information.

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.

PROZAC and olanzapine in combination – Also refer to the Adverse Reactions section of the package insert for Symbyax.

Contraindication:

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PROZAC or within 5 weeks of stopping treatment with PROZAC. Do not use PROZAC within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start PROZAC in a patient who is being treated with linezolid or intravenous methylene blue.

Pimozide: Do not use. Risk of QT prolongation and drug interaction.

Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing PROZAC. Do not use thioridazine within 5 weeks of discontinuing PROZAC.

When using PROZAC and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.

Warnings and Precautions:
  • Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults: Monitor for clinical worsening and suicidal thinking and behavior.
  • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including PROZAC, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue PROZAC and serotonergic agents and initiate supportive treatment. If concomitant use of PROZAC with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
  • Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena .
  • Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania.
  • Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshol.
  • Altered Appetite and Weight: Significant weight loss has occurred.
  • Increased Risk of Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, warfarin, or other drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding.
  • Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
  • Hyponatremia: Has been reported with PROZAC in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs.
  • Anxiety and Insomnia: May occur.
  • QT Prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with PROZAC use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patients with risk factors for QT prolongation.
  • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery.
  • Long Half-Life: Changes in dose will not be fully reflected in plasma for several weeks.
  • PROZAC and Olanzapine in Combination: When using PROZAC and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
  • Sexual Dysfunction: PROZAC may cause symptoms of sexual dysfunction.
See package insert for full prescribing information.