FLUOXETINE HYDROCHLORIDE Capsule - DailyMed

These highlights do not include all the information needed to use FLUOXETINE safely and effectively. See full prescribing information for FLUOXETINE. Initial U.S. Approval: 1987 WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS See full prescribing information for complete boxed warning.

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for Major Depressive Disorder (MDD) and other psychiatric disorders (5.1).

RECENT MAJOR CHANGES

Warnings and Precautions: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions (5.2)

01/2009

INDICATIONS AND USAGE

Fluoxetine is a selective serotonin reuptake inhibitor indicated for:

• Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1)
• Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years (1.2)
• Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3)
• Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4)

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)	–

• Consider tapering the dose of fluoxetine for pregnant women during the third trimester (2.7)
• 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)

DOSAGE FORMS AND STRENGTHS

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

CONTRAINDICATIONS

• Do not use with an MAOI or within 14 days of discontinuing an MAOI due to risk of drug interaction. At least 5 weeks should be allowed after stopping fluoxetine before treatment with an MAOI (4, 7.1)
• Do not use with pimozide due to risk of drug interaction or QTc prolongation (4, 7.9)
• Do not use with thioridazine due to QTc interval prolongation or potential for elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine (4, 7.9)

WARNINGS AND PRECAUTIONS

• Clinical Worsening and Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior (5.1)
• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Have been reported with fluoxetine. Discontinue fluoxetine and initiate supportive treatment (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 drugs that affect coagulation may potentiate the risk of gastrointestinal or other bleeding (5.7)
• Hyponatremia: Has been reported with fluoxetine in association with syndrome of inappropriate antidiuretic hormone (SIADH) (5.8)
• Anxiety and Insomnia: May occur (5.9)
• Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery (5.11)
• Long Half-Life: Changes in dose will not be fully reflected in plasma for several weeks (5.12)

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)

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

• Monoamine Oxidase Inhibitors (MAOI): Fluoxetine is contraindicated for use with MAOI’s, or within 14 days of discontinuing an MAOI due to risk of drug interaction. At least 5 weeks should be allowed after stopping fluoxetine before starting treatment with an MAOI (4, 7.1)
• Pimozide: Fluoxetine is contraindicated for use with pimozide due to risk of drug interaction or QTc prolongation (4, 7.9)
• Thioridazine: Fluoxetine is contraindicated for use with thioridazine due to QTc interval prolongation or potential for elevated thioridazine plasma levels. Do not use thioridazine within 5 weeks of discontinuing fluoxetine (4, 7.9)
• Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway (7.9)
• Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued (7.9)
• 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 (7.9)
• Antipsycotics: Potential for elevation of haloperidol and clozapine levels (7.9)
• Anticonvulsants: Potential for elevated phenytoin and carbamazepine levels and clinical anticonvulsant toxicity (7.9)
• Serotonergic Drugs: Potential for Serotonin Syndrome (5.2, 7.3)
• Triptans: There have been rare postmarketing reports of Serotonin Syndrome with use of an SSRI and a triptan (5.2, 7.4)
• Tryptophan: Concomitant use with tryptophan is not recommended (5.2, 7.5)
• Drugs that Interfere with Hemostasis (e.g. NSAIDs, Aspirin, Warfarin): May potentiate the risk of bleeding (7.6)
• Drugs Tightly Bound to Plasma Proteins: May cause a shift in plasma concentrations (7.8, 7.9)

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)
• 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: 6/2010