Fluoxetine Hydrochloride (8 brand names, 4 dosage forms, 1 route)
Available dosage forms: SOLUTION, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS.
Routes of administration: ORAL.
Brand Names
- FLUOXETINE
- FLUOXETINE HYDROCHLORIDE
- OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
- PROZAC
- PROZAC WEEKLY
- SARAFEM
- SELFEMRA
- SYMBYAX
Boxed Warning
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 [see Warnings and Precautions (5.1)] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)] . Fluoxetine is not approved for use in children less than 7 years of age [see Warnings and Precautions (5.1)and Use in Specific Populations (8.4)] . When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.
Indications and Usage
Fluoxetine capsules are 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 capsules and Olanzapine in Combination are 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 capsules monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression. When using fluoxetine capsules and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.
Contraindications
When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.
Warnings and Precautions
When using fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax.
Adverse Reactions
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 [see Boxed Warningand Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Allergic Reactions and Rash [see Warnings and Precautions (5.3)] Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania [see Warnings and Precautions (5.4)] Seizures [see Warnings and Precautions (5.5)] Altered Appetite and Weight [see Warnings and Precautions (5.6)] Increased Risk of Bleeding [see Warnings and Precautions (5.7)] Angle-Closure Glaucoma [see Warnings and Precautions (5.8)] Hyponatremia [see Warnings and Precautions (5.9)] Anxiety and Insomnia [see Warnings and Precautions (5.10)] QT Prolongation [see Warnings and Precautions (5.11)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.13)] Discontinuation Adverse Reactions [see Warnings and Precautions (5.15)] Sexual Dysfunction [see Warnings and Precautions (5.17)] When using fluoxetine and olanzapine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax.
Drug Interactions
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.
Mechanism of Action
Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.
Overdosage
The following have been reported with fluoxetine overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, torsade de pointes, and cardiac arrest. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other pro-serotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a fluoxetine overdose. Consider contacting a Poison Center (1-800-221-2222) or a medical toxicologist for additional overdosage management recommendations.