Fluoxetine

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 ) ]. …

• 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 used in patients with hepatic impairment, the elderly, and for patients with concurrent disease or on multiple concomitant medications Fluoxetine capsules 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 Major Depressive Disorder Initial Treatment Adult - Initiate fluoxetine capsu …

• Fluoxetine Capsules USP, 10 mg are white to off white powder filled in size ''4'' hard gelatin capsules with green opaque cap and green opaque body imprinted ''C28'' • Fluoxetine Capsules USP, 20 mg are white to off white powder filled in size ''2'' hard gelatin capsules with green opaque cap and yellow opaque body imprinted ''C29'' • Fluoxetine Capsules USP, 40 mg white to off white powder fill …

• Use of fluoxetine in children — The efficacy of fluoxetine
• For the treatment of Major Depressive Disorder was demonstrated in two 8- to 9-week placebo-controlled clinical trials with 315 pediatric outpatients ages 8 to ≤18 [ see Clinical Studies ]
• The efficacy of fluoxetine for the treatment of OCD was demonstrated in one 13-week placebo-controlled clinical trial with 103 pediatric outpatients ages 7 to

US fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age. The efficacy in geriatric patients has been established [ see Clinical Studies (14.1 )]. For pharmacokinetic information in geriatric patients, [see Clinical Pharmacology (12.4)]. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking fluoxetine as monotherapy or in combination with olanzapine
• When using fluoxetine and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax
• General Information Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine and to reread it each time the prescription is renewed. …

• 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. …

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): ( 2.9 , 2.10 , 4.1 , 5.2 ) • Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.7 ) • Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.7 ) • CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs ( 7.2 ) • Benzodiazepines: Diazepam – increased t ½ , alprazolam - further psychomotor performance dec …

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 ( 5.1 ) • 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. …

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 Warning and 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 …

8.1 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.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/. …

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). …

9.3 Dependence Fluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. While the premarketing clinical experience with fluoxetine did not reveal any tendency for a withdrawal syndrome or any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.