Fluoxetine

What it is and how it works

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.

Indications

Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies ]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies ]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies ]. • Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies ]. Fluoxetine capsules 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 patient, 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.

Dosage and administration (summary)

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 Episode s 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 use…

Contraindications

When using fluoxetine 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 fluoxetine or within 5 weeks of stopping treatment with fluoxetine. Do not use fluoxetine capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders.

Warnings and precautions

When using fluoxetine 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 fluoxetine, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue fluoxetine and serotonergic agents and initiate supportive treatment.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth…

Storage and supply

How Supplied Fluoxetine capsules USP, 10 mg* White to off white powder filled in size "4" hard gelatin capsules with green opaque cap and green opaque body imprinted "C28" Bottles of 30 NDC 72241-007-22 Bottles of 100 NDC 72241-007-05 Bottles of 500 NDC 72241-007-10 Bottles of 1,000 NDC 72241-007-11 Fluoxetine Capsules USP, 20 mg* White to off whit…

Source: Fluoxetine (Fluoxetine) — US FDA prescribing information, 2024-07-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.