Fluoxetine

PROZAC ® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa. Acute treatment of Panic Disorder, with or without agoraphobia. PROZAC 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).

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

Indication Adult Pediatric MDD 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa 60 mg/day in am Panic Disorder 10 mg/day (initial dose) Depressive Episodes Associated with Bipolar I Disorder. 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. 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.

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

Boxed warning (suicidal thoughts and behaviors): Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24, there was a reduction in risk with antidepressant use in patients aged 65 and older. When using PROZAC and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax. 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.

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults Serotonin Syndrome Allergic Reactions and Rash Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania Seizures Altered Appetite and Weight Increased Risk of Bleeding Angle-Closure Glaucoma Hyponatremia Anxiety and Insomnia QT Prolongation Potential for Cognitive and Motor Impairment Discontinuation Adverse Reactions Sexual Dysfunction When using PROZAC and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.

As with all drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic drug inhibition or enhancement, etc.) is a possibility. Monoamine Oxidase Inhibitors (MAOIs): Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway. Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with PROZAC or when PROZAC has been recently discontinued. CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs. Benzodiazepines: Diazepam – increased t½, alprazolam - further psychomotor performance decrement due to increased levels. Antipsychotics: Potential for elevation of haloperidol and clozapine levels. Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity.

Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).