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Fluoxetine Hydrochloride

Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: N-Methyl-γ-[4-(trifluoromethyl)phenoxy]benzenepropanamine hydrochloride
Molecular Formula: C₁₇H₁₈F₃NO•HCl
CAS Number: 56296-78-7
Brands: Prozac, Prozac Weekly, Sarafem, Symbyax

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.¹ ^a ^b Fluoxetine is not approved for use in pediatric patients except for patients with major depressive disorder or obsessive-compulsive disorder.¹ (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.^a ^b
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.^a ^b ^c
Appropriately monitor and closely observe all patients who are started on fluoxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.¹ ^a ^b ^c (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

Antidepressant; a selective serotonin-reuptake inhibitor (SSRI).¹ ² ¹⁶ ²⁸ ⁵⁰ ⁵¹

Uses for Fluoxetine Hydrochloride

Major Depressive Disorder

Management of major depressive disorder.¹ ³⁴⁵ ⁴⁰⁶ ⁴⁰⁷ ⁴¹³

Efficacy in hospital settings not established.¹

Obsessive-Compulsive Disorder (OCD)

Management of OCD.¹ ⁴⁰⁸ ⁴⁰⁹ ⁴¹³

Premenstrual Dysphoric Disorder (PMDD)

Management of PMDD (previously late luteal phase dysphoric disorder).³⁶¹ ³⁶² ³⁶³ ³⁶⁴ ³⁶⁶

Eating Disorders

Management of moderate to severe bulimia nervosa (at least 3 bulimic episodes per week for 6 months).¹ ⁴¹⁰

SSRIs usually are preferred drugs in management of bulimia because of more favorable adverse effect profile.³⁶⁵

Also has been used for management of anorexia nervosa†.⁷⁷ ⁷⁸ ²⁵⁵ ³⁵⁵

Not recommended as the sole or primary treatment of anorexia nervosa†.³⁵⁵

Panic Disorder

Management of panic disorder with or without agoraphobia.¹ ⁷⁵ ¹⁷⁷ ⁴¹⁸ ⁴¹⁹ ⁴³⁵ ⁴³⁷

Bipolar Disorder

Short-term treatment of acute depressive episodes (alone† or in combination with olanzapine) in patients with bipolar disorder (bipolar depression).³ ²¹⁷ ⁴⁴⁸ ⁵⁰⁷ ⁵⁰⁸

May cause manic reactions when used as monotherapy in some patients;¹ ⁶ ⁷⁰ ⁸⁵ ⁸⁶ ⁸⁷ ⁸⁸ ²³⁰ should not be used without mood stabilizing agents (e.g., lithium).³⁸⁴

Obesity

Has been used for the short-term treatment of exogenous obesity†.¹²³ ¹⁶² ¹⁹⁵ ²²⁸

Cataplexy

Has been used for the symptomatic management of cataplexy† in a limited number of patients with cataplexy and associated narcolepsy.¹²⁹

Alcohol Dependence

Has been used in the management of alcohol dependence†.²¹⁷ ²¹⁹

Studies of SSRIs have generally shown modest effects on alcohol consumption.³⁸¹ ³⁸²

Fluoxetine Hydrochloride Dosage and Administration

General

Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of fluoxetine, and at least 5 weeks to elapse between discontinuance of fluoxetine and initiation of an MAO inhibitor or thioridazine therapy.¹
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.¹ ^a ^b ^c (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; use lowest effective dosage and periodically reassess need for continued therapy.¹
Avoid abrupt discontinuance of therapy.¹ To avoid withdrawal reactions, taper dosage gradually.¹ (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.¹ ⁴⁸⁰ ⁴⁸¹ ⁴⁸² ⁴⁹¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Administration

Oral Administration

Administer conventional capsules, tablets, and solution orally once (in the morning)¹ ² ⁷⁰ or twice daily (preferably in the morning and at noon) without regard to meals.¹ ² ⁴ ⁷ ⁵⁸ ²¹⁷ If sedation occurs, the second dose may be administered at bedtime.²¹⁷

Administer delayed-release preparation once weekly without regard to meals.¹ ² ⁴ ⁷ ⁵⁸ ⁴⁰⁰ ⁴⁰¹

Administer fixed-combination fluoxetine/olanzapine capsules (Symbyax) once daily in the evening.⁴⁴⁸

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as fluoxetine hydrochloride; dosage is expressed in terms of fluoxetine.¹

Consider prolonged elimination half-life of fluoxetine and norfluoxetine when titrating dosage or discontinuing therapy.¹ ² Several weeks may be required before full effect of dosage alterations is realized.¹ ² ³ ⁴⁸ ⁵⁰ ⁵² ⁵³ ⁵⁶

Pediatric Patients

Major Depressive Disorder

Oral

Children and adolescents ≥8 years of age: initially, 10 or 20 mg daily.¹ ³⁹⁰ ³⁹¹ ³⁹² If therapy is initiated at 10 mg daily, it can be increased after 1 week to 20 mg daily.¹

Manufacturer states that both the initial and target dose in lower weight children may be 10 mg daily.¹

An increase in dosage to 20 mg daily may be considered after several weeks in lower weight children if insufficient clinical improvement is observed.¹

Obsessive-Compulsive Disorder

Oral

Children and adolescents ≥7 years of age: initially, 10 mg daily.¹

In adolescents and higher weight children, the dosage should be increased to 20 mg daily after 2 weeks; additional dosage increases may be considered after several more weeks if insufficient clinical improvement is observed.¹

In lower weight children, dosage increases may be considered after several weeks if insufficient clinical improvement is observed.¹

Usual dosages: 20–60 mg daily for adolescents and higher weight children or 20–30 mg daily for lower weight children.¹

Adults

Major Depressive Disorder

Oral

As conventional capsules, tablets, or solution: Initially, 20 mg once daily (in the morning). May initiate with lower dosage (e.g., 5 mg daily, 20 mg every 2–3 days).² ²¹² If no improvement is apparent after several weeks of therapy with 20 mg daily, an increase in dosage may be considered.¹ ² ¹⁰

Usual dosage: 10–80 mg daily.¹

Delayed-release capsules: 90 mg once weekly, beginning 7 days after the last 20 mg daily dose as conventional capsules, tablets, or solution.¹ ⁴⁰⁰ ⁴⁰¹

If a satisfactory response is not maintained, consider reestablishing daily dosage regimen with conventional capsules, tablets, or solution.¹ ⁴⁰⁰

Optimum duration not established; may require several months of therapy or longer.¹ ²¹⁵ ²¹⁶ ²³³

Obsessive-Compulsive Disorder

Oral

Initially, 20 mg once daily.¹ If no improvement is apparent after several weeks, dosage may be increased.¹

Usual dosage: 20–60 mg daily.¹

Premenstrual Dysphoric Disorder

Oral

20 mg once daily given continuously throughout the menstrual cycle or intermittently (i.e., only during the luteal phase, starting 14 days prior to the anticipated onset of menstruation and continuing through the first full day of menses).³⁶⁶

If the intermittent dosing regimen is used, it should be repeated with each new menstrual cycle.³⁶⁶ ⁴⁰⁵

Eating Disorders

Bulimia Nervosa

Oral

60 mg daily (in the morning);¹ dosage may be decreased as necessary to minimize adverse effects.³⁵⁵ Alternatively, dosage may be titrated up to recommended initial dosage over several days.¹

Anorexia Nervosa†

Oral

40 mg daily in weight-restored patients.³⁴⁵

Panic Disorder

Oral

Initially, 10 mg daily.¹ ⁴¹⁸ Increase dosage after 1 week to 20 mg daily.¹ ⁴¹⁸ 10–60 mg is effective; 20 mg daily most frequently used.¹ ⁴⁸ Dosages >60 mg daily not systematically evaluated.¹

Bipolar Disorder

Monotherapy†

Oral

20–60 mg daily in conjunction with a mood-stabilizing agent (e.g., lithium).³⁸⁴

Combination Therapy

Oral

Initially, 25 mg of fluoxetine and 6 mg of olanzapine once daily in the evening as a fixed-combination capsule (Symbyax 6/25).⁴⁴⁸

This dosage generally should be used as initial and maintenance therapy in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or those with factors that may slow metabolism of the drugs(s) (e.g., female gender, geriatric age, nonsmoking status); when indicated, dosage should be escalated with caution.⁴⁴⁸

In other patients, increase dosages according to patient response and tolerance as indicated.⁴⁴⁸ In clinical trials, antidepressive efficacy was demonstrated at olanzapine dosages ranging from 6–12 mg daily and fluoxetine dosages ranging from 25–50 mg daily.⁴⁴⁸ ⁵⁰⁷ ⁵⁰⁸ Dosages exceeding 18 mg of olanzapine and 75 mg of fluoxetine not evaluated in clinical studies.⁴⁴⁸

Although the manufacturer states that long-term efficacy (>8 weeks) not established, patients have received the fixed combination ≤24 weeks in clinical trials.⁴⁴⁸ ⁵⁰⁷ ⁵⁰⁸ If used for >8 weeks, periodically reassess need for continued therapy.⁴⁴⁸

Cataplexy†

Oral

20 mg once or twice daily in conjunction with CNS stimulant therapy (e.g., dextroamphetamine, methylphenidate).³⁸⁰

Alcohol Dependence†

Oral

60 mg daily has been used.²⁸⁹

Higher than average antidepressant SSRI dosage apparently is required for reduced alcohol intake; fluoxetine 40 mg daily is comparable to placebo in efficacy.²⁸⁹

Prescribing Limits

Adults

Oral

Conventional capsules, tablets, or solution: Maximum 80 mg daily.¹ ² ³⁶⁶

Special Populations

Hepatic Impairment

Reduce dose and/or frequency;¹ ² ⁴ ⁵¹ some clinicians recommend a 50% reduction in initial dosage for patients with well-compensated cirrhosis.⁵¹

Carefully individualize dosage in substantial hepatic impairment; adjust based on tolerance and therapeutic response.⁵¹

Renal Impairment

Consider reduction in dosage and/or frequency particularly in severe renal impairment.¹ ² ²¹⁷ Supplemental doses after hemodialysis not necessary.⁴ ⁵⁰

Geriatric Patients

Consider reducing dose and/or frequency.¹

Cautions for Fluoxetine Hydrochloride

Contraindications

Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.¹ MAO inhibitors and thioridazine are contraindicated within 5 weeks after discontinuance of fluoxetine.² ²⁹⁸ ³⁶⁵ ³⁶⁶ (See Drug Interactions under Warnings and see Interactions.)
Concurrent pimozide therapy.¹ (See Specific Drugs under Interactions.)
Known hypersensitivity to fluoxetine or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Drug Interactions

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).¹ (See Serotonin Syndrome under Cautions and also see Interactions.)

Concomitant use with thioridazine expected to be associated with prolonged QT_c interval and serious ventricular arrhythmias (e.g., torsades de pointes-type arrhythmias) and sudden death.¹ (See Specific Drugs under Interactions.)

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT₁ receptor agonists [“triptans”]) or drugs that impair serotonin metabolism (e.g., MAO inhibitors).¹ ⁴⁹² Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).¹ ⁴⁹² (See Interactions.)

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.¹ ⁵¹² ^a ^b ^c However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.^a ^b ^c

Appropriately monitor and closely observe patients receiving fluoxetine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.¹ ⁵¹² ^a ^b ^c (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.^b ^c Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.¹ ^a ^b ^c If decision is made to discontinue therapy, taper fluoxetine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.¹ ^b (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.¹ ^b

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) or nonpsychiatric disorders.¹ ^b

Bipolar Disorder

May unmask bipolar disorder.¹ ^b (See Activation of Mania or Hypomania under Cautions.)

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.¹ ^b

Fetal/Neonatal Morbidity and Mortality

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, reported in neonates exposed to fluoxetine, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.¹ ⁴⁶¹ ⁴⁶² ⁴⁸⁰ ⁴⁸⁹ ⁴⁹⁰ ⁴⁹¹

Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial neonatal morbidity and mortality.⁴⁹³ ⁴⁹⁵

Carefully consider potential risks and benefits of treatment when used during third trimester of pregnancy.¹ ⁴⁸⁰ ⁴⁹⁰ ⁴⁹¹ Consider cautiously tapering dosage during third trimester prior to delivery.¹ ⁴⁸⁰ ⁴⁸¹ ⁴⁸² ⁴⁹¹ (See Pregnancy under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Possible anaphylactoid reactions (e.g., bronchospasm, angioedema, laryngospasm, and/or urticaria).¹

Rash and/or urticaria, sometimes associated with systemic manifestations (e.g., fever, leukocytosis, arthralgia, edema, carpal tunnel syndrome, respiratory distress, lymphadenopathy, proteinuria, mild elevation in serum aminotransferase concentrations, vasculitis, lupus-like syndrome) reported; systemic manifestations may be serious.¹ ² ²³⁴ ²⁷⁹

If rash, urticaria, and/or other manifestations of hypersensitivity for which alternative etiologies cannot be identified occur, discontinue therapy.¹ ² ²² ²¹⁷

General Precautions

Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding; use with caution.¹ ⁴⁵² ⁴⁸⁷ ⁴⁸⁸

Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.¹ ⁴⁵² ⁴⁸⁷ ⁴⁸⁸ (See Interactions.)

Nervous System Effects

Possible dose-related⁴ ⁶⁹ ²¹¹ ²¹⁷ nervousness,¹ ² ¹⁵ ⁶⁰ ⁶¹ ⁶³ ⁶⁵ ⁶⁶ ⁶⁷ ⁷⁰ ⁷¹ ⁷² ¹²² ²³⁴ anxiety,¹ ² ¹⁰ ¹⁵ ⁶¹ ⁶³ ⁶⁵ ⁶⁷ ⁷⁰ ⁷⁵ ¹²² ²³⁴ and insomnia.¹ ² ¹⁰ ¹⁵ ⁶¹ ⁶³ ⁶⁶ ⁶⁷ ⁶⁹ ⁷⁰ ⁷¹ ⁷² ⁷⁵ ¹²² ¹⁷⁶ ²³⁴

Altered Appetite and Weight

Possible anorexia and weight loss.¹ ² ¹⁵ ⁶⁰ ⁶¹ ⁶³ ⁶⁵ ⁶⁶ ⁶⁷ ⁶⁹ ⁷² ¹²² ¹⁶¹ ¹⁷⁶ Use with caution in patients who may be adversely affected (e.g., underweight patients).¹

Activation of Mania or Hypomania

Possible hypomania,⁷⁰ ⁸⁶ ²³⁴ mania,⁷⁰ ⁸⁵ ⁸⁶ ⁸⁷ ⁸⁸ ²¹⁷ ²³⁰ ²³⁴ ²⁵⁸ ²⁶⁷ ²⁶⁸ and manic reaction.¹ ⁶ ⁷⁰ ²³⁴ May be more likely in patients with bipolar disorder.⁸⁵ ¹⁹² (See Bipolar Disorder under Cautions.)

Seizures

Possible seizures;¹ ² ⁶ ¹⁵ ⁵⁶ ⁸⁹ ⁹¹ use with caution in patients with a history of seizures.¹ ² ⁹¹

Long Elimination Half-Lives

Long elimination half-lives of fluoxetine and its metabolites affect dosage titration, withdrawal, duration of adverse effects, and drug interactions.¹ ² ³ ⁴⁸ ⁵⁰ ⁵² ⁵³ ⁵⁶ ²¹⁷ Adverse effects may resolve slowly following discontinuance of the drug.¹ ² ²¹⁷

Withdrawal of Therapy

Possibly severe withdrawal reactions (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania); avoid abrupt discontinuance of therapy.¹ Taper dosage gradually (e.g., over a period of several weeks).¹ Plasma concentrations of fluoxetine and norfluoxetine decline gradually after cessation of therapy, which may minimize risk of withdrawal symptoms.¹ (See Half-life under Pharmacokinetics.)

Concomitant Illnesses

Safety in patients with recent history of MI or those with unstable heart disease not established.¹ ² ³

Use with caution in patients with concomitant illnesses affecting metabolism or hemodynamic response.¹

May alter blood glucose concentrations; adjust insulin and/or oral antidiabetic dosage as necessary when therapy is initiated or discontinued in patients with diabetes mellitus.¹

Cognitive/Physical Impairment

Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery).¹

Hyponatremia

Possible hyponatremia in older patients,¹ ⁹⁰ ²⁸¹ patients with depleted fluid volume, and those receiving diuretics.¹

Use of Fixed Combinations

When fluoxetine is used in fixed combination with olanzapine, precautions associated with olanzapine must be considered.⁴⁴⁸

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.¹ ⁴ Prolonged seizures have occurred rarely.¹

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.⁴⁹³ ⁴⁹⁴

Lactation

Distributed into milk; use not recommended.¹

Pediatric Use

Safety and efficacy not established in children <8 years of age for major depressive disorder and in children <7 years of age for OCD.¹

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).¹ ^b However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs, including fluoxetine, and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.⁵¹² No suicides occurred in these pediatric trials.¹ ⁵¹² ^b

Carefully consider these findings when assessing potential benefits and risks of fluoxetine in a child or adolescent for any clinical use.¹ ⁵¹² ^a ^b ^c (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.^a ^b (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Decreased clearance with cirrhosis; use with caution and at reduced dose and/or frequency.¹ ² ⁵¹ (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Anxiety, nervousness, insomnia, drowsiness, fatigue or asthenia, tremor, dizziness or lightheadedness, anorexia, nausea, diarrhea, vasodilation, dry mouth, abnormal vision, decreased libido, abnormal ejaculation, rash, and sweating.¹ ² ³ ⁵ ⁶ ¹⁰ ⁶¹ ⁶³ ⁷¹ ⁷² ²³⁴

Interactions for Fluoxetine Hydrochloride

Extensively metabolized;¹ ² ³ ⁵¹ ⁵³ inhibits CYP2D6¹ ³⁶⁶ ³⁸⁶ ³⁹⁹ and to much less extent CYP3A4.¹ ³⁶⁶

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (serotonin syndrome) with serotonergic agents.¹ ²⁸³ ²⁹⁹ ³⁰⁰ ³⁰¹ ³⁰³ ⁴⁹² Avoid such use, or use with caution.¹ ²⁰⁰ ²⁹⁹ ⁴⁹² (See Serotonin Syndrome under Cautions.)

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2D6 or CYP3A4: clinically important pharmacokinetic interaction unlikely.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP2D6: potential pharmacokinetic interaction.¹ Fluoxetine inhibits CYP2D6 activity, may increase plasma concentrations of drugs metabolized by CYP2D6.¹

Substrates of CYP3A4; pharmacokinetic interaction not likely to be clinically important.¹

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect coagulation; use with caution.¹ ⁴⁵² ⁴⁸⁷ ⁴⁸⁸

Specific Drugs

Drug	Interaction	Comments
Alcohol	Does not potentiate cognitive and motor effects of alcohol;⁷ ⁹⁹ ¹¹⁴ ²⁰⁶ ²⁰⁷ possible serotonergically-mediated pharmacodynamic interaction in CNS⁹⁹ ¹¹⁵ ¹³⁴ ¹³⁸ ¹⁵⁷ ¹⁷³ ²¹³ ²¹⁴	Concomitant use is not recommended¹
Amphetamine	Decreased amphetamine metabolism; potential serotonin syndrome³⁹²
Anticoagulants (e.g., warfarin)	Altered anticoagulant effects, including increased bleeding¹ ³⁶⁶	Carefully monitor patients receiving warfarin when fluoxetine is initiated or discontinued¹ ³⁶⁶
Antidiabetic agents	May alter blood glucose concentrations in patients with diabetes mellitus¹	Adjust insulin and/or antidiabetic dosages as needed when fluoxetine therapy is initiated or discontinued¹
β-Adrenergic blocking agents (e.g., metoprolol, propranolol)	Increased plasma concentrations of β-adrenergic blocking agents metabolized by CYP2D6;³⁶⁵ possible cardiac toxicity³⁶⁵	Renally eliminated β-adrenergic blocking agents (e.g., atenolol) may be a safer choice³⁶⁵
Antidepressants, tricyclic (TCAs)	Increased plasma TCA concentrations¹ ³⁶⁶	Observe patient closely for adverse effects.²²⁷ ²⁵⁹ Plasma TCA concentrations may need to be monitored and TCA dosages reduced when fluoxetine is administered concurrently or has been recently discontinued¹
Benzodiazepines	Increased plasma concentrations of diazepam and alprazolam³⁶⁶	Clinically important interaction possible in geriatric or other susceptible patients²¹⁷
Buspirone	Possible serotonin syndrome³⁰³ ³²⁴
Carbamazepine	Increased plasma concentrations of carbamazepine and its active metabolite;²⁶⁰ ²⁶¹ ²⁶² ²⁶³ ²⁶⁴ carbamazepine toxicity has been reported²⁶⁰ ²⁶¹ ²⁶³	Monitor patient and plasma carbamazepine concentrations closely when fluoxetine therapy is initiated or discontinued and adjust carbamazepine dosage accordingly²⁶² ²⁶³ ²⁶⁴
Clozapine	Increased plasma clozapine concentrations¹ ³⁶⁶ ³⁹⁶	Use with caution, monitor closely, and consider decreasing clozapine dosage³⁶⁷
Diuretics	Increased risk of hyponatremia
Haloperidol	Increased plasma haloperidol concentrations;¹ ³⁶⁶ severe extrapyramidal symptoms have occurred¹¹⁸
5-HT₁ receptor agonists (“triptans”)	Potentially life-threatening serotonin syndrome¹ ⁴⁹²	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated¹ ³⁶⁶ ⁴⁹²
Isoniazid	Potential for serotonin syndrome³⁰⁴ Isoniazid has some MAO-inhibiting activity³⁰⁴
Linezolid	Possible serotonin syndrome¹ ⁵¹¹	Use with caution¹ ⁵¹¹
Lithium	Increased or decreased serum lithium concentrations¹ ¹⁰⁷ ²⁵⁰ ³⁰³ ³²⁴ Lithium toxicity and/or serotonin syndrome has been reported¹ ¹⁰⁷ ²⁵⁰ ³⁰³ ³²⁴	Use with caution ¹ ¹⁰⁷ ³²⁴ and monitor serum lithium concentrations closely¹
MAO inhibitors	Potentially fatal serotonin syndrome¹ ³⁰⁰ ³⁰³ ³²³	Concomitant use is contraindicated¹ Allow at least 5 weeks to elapse between discontinuance of fluoxetine therapy and initiation of MAO inhibitor therapy ¹ ¹²⁰ ²⁹⁵ ²⁹⁸ and at least 2 weeks between discontinuance of MAO inhibitor therapy and initiation of fluoxetine¹ ² ²⁹⁸
NSAIAs (e.g., aspirin)	Increased risk of bleeding¹ ⁴⁵² ⁴⁸⁷ ⁴⁸⁸	Use with caution¹
Pentazocine	Adverse effects resembling serotonin syndrome³⁰³
Phenytoin	Increased plasma phenytoin concentrations and phenytoin toxicity¹
Pimozide	Possible increased risk of QT_c interval prolongation¹ Bradycardia, altered mental status (e.g., stupor, inability to think clearly), and/or hypersalivation reported rarely with concomitant use⁴⁷⁷ ⁴⁷⁸ ⁴⁷⁹	Concomitant use contraindicated¹
Protein-bound drugs	Displaces and is displaced by protein-bound drugs¹ ³⁶⁶	Monitor for possible adverse effects with concomitant use²¹⁷
Risperidone	Possible increased risperidone plasma concentrations; tardive dyskinesia reported³⁶⁸
Selegiline	Possible serotonin syndrome³⁰⁰ ³⁰³ ³¹² ³¹³	Avoid concomitant use³¹² ³¹³ Allow at least 5 weeks to elapse between discontinuance of fluoxetine therapy and initiation of selegiline ³¹³ and at least 2 weeks between discontinuance of selegiline and initiation of fluoxetine³¹² ³¹³
Sibutramine	Possible serotonin syndrome⁴⁹²	Use with caution⁴⁹²
Stimulants (e.g., methylphenidate)	Potential serotonin syndrome³⁹²	Do not exceed maximum fluoxetine dosage of 20 mg daily³⁹²

Thioridazine	Increased plasma thioridazine concentrations;³⁶⁵ serious ventricular arrhythmias and sudden death are possible¹ ³⁶⁵ ³⁶⁶	Concomitant use is contraindicated; an interval of at least 5 weeks should elapse between discontinuance of fluoxetine and initiation of thioridazine¹
Tramadol	Possible serotonin syndrome¹	Use with caution¹
Trazodone	Increased plasma trazodone concentrations and adverse effects²²⁵ ²⁵⁹	Observe patient closely for adverse effects ²²⁷ ²⁵⁹ and decrease trazodone dosage as necessary¹⁰³ ²²⁵ ²²⁷
Tryptophan and other serotonin precursors	Possible serotonin syndrome¹ ² ³ ¹⁰⁰ ³⁰³	Concomitant use not recommended¹
Warfarin	Possible increased PT and risk of bleeding¹	Use with caution¹

Fluoxetine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Oral bioavailability in humans not fully elucidated,⁴ but at least 60–80% of an oral dose appears to be absorbed.⁴ ⁷

Commercially available conventional and extended-release capsules, tablets, and oral solution are bioequivalent.¹

Onset

Antidepressant effect usually occurs within 1–4 weeks.¹ ² ⁴ ¹⁶ ⁶¹ ⁶⁹ ⁷¹ ⁷²

Maximal therapeutic effect in OCD may take 5 weeks or longer.¹ ⁴⁴¹

Therapeutic effect in PMDD usually occurs in 2–4 weeks.³⁶¹ ³⁶² ³⁶⁴

Food

Food does not appear to affect systemic bioavailability, although it may delay absorption by 1–2 hours.¹

Distribution

Extent

Crosses the blood-brain barrier in humans.¹ ⁵⁴ ⁵⁶

Crosses the placenta in animals.¹ ⁵⁴ ⁵⁶

Distributed into milk in humans.¹ ⁵⁴ ⁵⁶

Plasma Protein Binding

Approximately 95%.¹

Elimination

Metabolism

Extensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites.¹

Elimination Route

Principally by hepatic metabolism to inactive metabolites excreted by the kidney.¹

Half-life

Elimination half-life of approximately 2–3 days after a single dose and 4–6 days after chronic administration for fluoxetine.¹

Elimination half-life of norfluoxetine (active metabolite) is approximately 4–16 days after acute and chronic administration.¹

Special Populations

In patients with chronic liver disease (e.g., cirrhosis), plasma clearances of fluoxetine and norfluoxetine reportedly are decreased and elimination half-lives are increased compared with that of healthy individuals.¹ ⁵¹

In patients with renal impairment, elimination half-lives of fluoxetine and norfluoxetine not substantially altered.¹ ³ ⁴ ⁵⁰

Stability

Storage

Oral

Capsules, Solution, and Tablets

15–30°C.¹

ActionsActions

Mechanism of action as an antidepressant or as an anti-obsessive agent is unclear but presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).¹ ² ³ ⁴ ⁷ ⁸ ¹³ ¹⁸ ²¹ ²⁸ ²⁹ ³¹ ³⁷ ⁷⁶ ¹³⁸
Mechanism of action in PMDD not mediated by the drug’s antidepressant or anti-obsessive effects.³⁶¹ ³⁶² ³⁶⁴
Potent and highly selective reuptake inhibitor of serotonin.¹ ² ³ ⁴ ⁷ ⁸ ¹³ ¹⁸ ²¹ ²⁸ ²⁹ ³¹ ³⁷ ⁷⁶ ¹³⁸ Increases synaptic concentrations of serotonin in the CNS but has little or no effect on other neurotransmitters.¹ ² ³ ⁷ ⁸ ¹³ ¹⁸ ²¹ ²⁸ ²⁹ ³¹ ³⁷ ⁷⁶ ¹³⁸ ²⁰¹ ³²⁸ ³²⁹ ³³⁰
No important anticholinergic, α₁-adrenergic blocking, or antihistaminic activity at usual therapeutic dosages.¹ ² ³ ⁷ ⁸ ¹³ ¹⁸ ²¹ ³¹ ²⁰¹
Generally less sedating than most other antidepressants (e.g., TCAs, MAO inhibitors).² ³ ⁴ ⁶ ⁶¹ ¹⁷⁶ ²⁰⁷

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.¹ ^a ^b ^c FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.¹ ^a ^b ^c
Importance of informing clinicians if symptoms of hypersensitivity (e.g., rash) develop during therapy.¹
Importance of understanding that full effects of the drug may not be apparent for more than 4–5 weeks following initiation of therapy.¹ ²
Importance of avoiding certain activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.¹
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol-containing beverages or products, as well as any concomitant illnesses (e.g., bipolar disorder) or personal or family history of suicidality or bipolar disorder.¹
Importance of informing patients of risk of serotonin syndrome with concurrent use of fluoxetine and 5-HT₁ receptor agonists (“triptans”) or other serotonergic agents.¹ ⁴⁹² Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.¹ ⁴⁹²
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹
Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Fluoxetine Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	10 mg (of fluoxetine)*	Prozac Pulvules	Dista
			Sarafem Pulvules	Lilly
		20 mg (of fluoxetine)*	Prozac Pulvules	Dista
			Sarafem Pulvules	Lilly
		40 mg (of fluoxetine)*	Prozac Pulvules	Dista
	Capsules, delayed-release (containing enteric-coated pellets)	90 mg (of fluoxetine)	Prozac Weekly	Dista
	Solution	20 mg (of fluoxetine) per 5 mL*	Prozac (with alcohol 0.23%)	Dista
	Tablets	10 mg (of fluoxetine)*	Fluoxetine Hydrochloride Tablets (scored)	Par, Teva
		20 mg (of fluoxetine)*	Fluoxetine Hydrochloride Tablets	Par

Fluoxetine Hydrochloride Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	25 mg (of fluoxetine) with Olanzapine 6 mg	Symbyax	Lilly
		25 mg (of fluoxetine) with Olanzapine 12 mg	Symbyax	Lilly
		50 mg (of fluoxetine) with Olanzapine 6 mg	Symbyax	Lilly
		50 mg (of fluoxetine) with Olanzapine 12 mg	Symbyax	Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

FLUoxetine HCl 10MG Tablets (PAR): 30/$13.99 or 90/$19.97

FLUoxetine HCl 20MG/5ML Solution (TEVA PHARMACEUTICALS USA): 120/$73.01 or 360/$199.99

FLUoxetine HCl 20MG Tablets (PAR): 30/$27.99 or 90/$65.97

FLUoxetine HCl 40MG Capsules (TEVA PHARMACEUTICALS USA): 30/$40.99 or 90/$119.97

PROzac 10MG Capsules (DISTA): 30/$203.64 or 90/$557.82

PROzac 20MG Capsules (DISTA): 30/$208.27 or 90/$600.34

PROzac 20MG/5ML Solution (DISTA): 120/$252.98 or 360/$712.97

PROzac 40MG Capsules (DISTA): 30/$398.49 or 90/$1156.21

PROzac Weekly 90MG Delayed-release Capsules (LILLY): 4/$149.22 or 12/$406.5

Sarafem 10MG Tablets (WARNER CHILCOTT PROF PROD DIV): 7/$66.52 or 21/$173.18

Sarafem 20MG Tablets (WARNER CHILCOTT PROF PROD DIV): 7/$64.85 or 21/$171.3

Selfemra 10MG Capsules (TEVA PHARMACEUTICALS USA): 28/$25 or 84/$74.99

Selfemra 20MG Capsules (TEVA PHARMACEUTICALS USA): 28/$27.98 or 84/$79.95

Symbyax 12-25MG Capsules (LILLY): 30/$609.97 or 90/$1809.99

Symbyax 12-50MG Capsules (LILLY): 30/$575.96 or 90/$1636.02

Symbyax 3-25MG Capsules (LILLY): 30/$299.98 or 90/$859.97

Symbyax 6-25MG Capsules (LILLY): 30/$385.97 or 90/$1109.91

Symbyax 6-50MG Capsules (LILLY): 30/$470.97 or 90/$1370.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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