Fluoxetine

FLUOXETINE- fluoxetine hydrochloride capsule
RedPharm Drug, Inc.

BOXED WARNING

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 [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.

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use fluoxetine capsules, USP safely and effectively. See full prescribing information for fluoxetine capsules, USP.
FLUOXETINE capsules, USP for oral use
Initial U.S. Approval: 1987

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants (5.1).
Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1).

When using fluoxetine and olanzapine in combination, also refer to Boxed Warning section of the package insert for Symbyax.

RECENT MAJOR CHANGES

Warnings and Precautions: Serotonin Syndrome (5.2) 01/2017

INDICATIONS AND USAGE

Fluoxetine capsules are a selective serotonin reuptake inhibitor indicated for:

Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) (1)
Acute and maintenance treatment of Bulimia Nervosa (1)
Acute treatment of Panic Disorder, with or without agoraphobia (1)

Fluoxetine capsules and olanzapine in combination for treatment of:

Acute Depressive Episodes Associated with Bipolar I Disorder (1)

DOSAGE AND ADMINISTRATION

Indication
Adult
Pediatric
MDD (2.1)
20 mg/day in am (initial dose)
10 to 20 mg/day (initial dose)
OCD (2.2)
20 mg/day in am (initial dose)
10 mg/day (initial dose)
Bulimia Nervosa (2.3)
60 mg/day in am
Panic Disorder (2.4)
10 mg/day (initial dose)
Depressive Episodes
Associated with Bipolar I
Disorder (2.5)
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)

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 (2.7)

Fluoxetine capsules and olanzapine in combination:

Dosage adjustments should be made with the individual components according to efficacy and tolerability (2.5)
Fluoxetine monotherapy is not indicated for the treatment of Depressive Episodes associated with Bipolar I Disorder (2.5)
Safety of the coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in adults. (2.5)
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 (2.5)

DOSAGE FORMS AND STRENGTHS

Capsules: 10 mg, 20 mg, and 40 mg (3)

CONTRAINDICATIONS

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 within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluoxetine in a patient who is being treated with linezolid or intravenous methylene blue (4.1)
Pimozide: Do not use. Risk of QT prolongation and drug interaction (4.2, 5.11, 7.7, 7.8)
Thioridazine: Do not use. Risk of QT interval prolongation and elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine. Do not use thioridazine within 5 weeks of discontinuing fluoxetine (4.2, 5.11, 7.7, 7.8)
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax (4)

WARNINGS AND PRECAUTIONS

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 (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort). If such symptoms occur, discontinue fluoxetine and initiate supportive treatment. If concomitant use of fluoxetine 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. (5.2) 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 (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort). If such symptoms occur, discontinue fluoxetine and initiate supportive treatment. If concomitant use of fluoxetine 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. (5.2)
Allergic Reactions and Rash: Discontinue upon appearance of rash or allergic phenomena (5.3)
Activation of Mania/Hypomania: Screen for Bipolar Disorder and monitor for mania/hypomania (5.4)
Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold (5.5)
Altered Appetite and Weight: Significant weight loss has occurred (5.6)
Abnormal 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 (5.7)
Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.8)
Hyponatremia: Has been reported with fluoxetine in association with syndrome of inappropriate antidiuretic hormone (SIADH). Consider discontinuing if symptomatic hyponatremia occurs (5.9)
Anxiety and Insomnia: May occur (5.10)
QT Prolongation: QT prolongation and ventricular arrhythmia including Torsades de Pointes have been reported with fluoxetine use. Use with caution in conditions that predispose to arrhythmias or increased fluoxetine exposure. Use cautiously in patients with risk factors for QT prolongation (4.2, 5.11)
Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery (5.13)
Long Half-Life: Changes in dose will not be fully reflected in plasma for several weeks (5.14)
Fluoxetine and Olanzapine in Combination: When using Fluoxetine and olanzapine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax (5.16)

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 (6.1)
Fluoxetine and olanzapine in combination – Also refer to the Adverse Reactions section of the package insert for Symbyax (6)
To report SUSPECTED ADVERSE REACTIONS, contact Vensun Pharmaceuticals, Inc. at 1-800-385-1540 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

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 t½, alprazolam — further psychomotor performance decrement due to increased levels (7.7)
Antipsychotics: Potential for elevation of haloperidol and clozapine levels (7.7)
Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity (7.7)
Serotonergic Drugs: (2.9, 2.10, 4.1, 5.2)
Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding (7.4)
Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations (7.6, 7.7)
Olanzapine: When used in combination with fluoxetine, also refer to the Drug Interactions section of the package insert for Symbyax (7.7)
Drugs that Prolong the QT Interval: Do not use fluoxetine with thioridazine or pimozide. Use with caution in combination with other drugs that prolong the QT interval (4.2, 5.11, 7.7, 7.8)

USE IN SPECIFIC POPULATIONS

Pregnancy: Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risks to the fetus (8.1)
Nursing Mothers: Breast feeding is not recommended (8.3)
Pediatric Use: Safety and effectiveness of fluoxetine in patients <8 years of age with Major Depressive Disorder and <7 years of age with OCD have not been established. Safety and effectiveness of fluoxetine and olanzapine in combination in patients <10 years of age for depressive episodes associated with Bipolar I Disorder have not been established. (8.4)
Hepatic Impairment: Lower or less frequent dosing may be appropriate in patients with cirrhosis (8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2017

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