Fluoxetine Hydrochloride

Pronunciation

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

Warning(s)

  • Suicidality
  • Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo 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.1 470 471 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 was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.1 470 471

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.1 470 471

  • 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.1 470 471 476 (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

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

Uses for Fluoxetine Hydrochloride

Major Depressive Disorder

Acute and maintenance treatment of major depressive disorder.1 2 3 4 15 16 60 61 63 65 66 67 68 69 70 71 72 73 74 80 122 171 176 209 210 345 406 407 413

APA states that effectiveness of antidepressants is generally comparable between and within classes of medications, including SSRIs, SNRIs, TCAs, MAO inhibitors, and other antidepressants (e.g., bupropion, mirtazapine, trazodone).a Choose antidepressant based mainly on patient preference; nature of prior response to medication; safety, tolerability, and anticipated adverse effects; concurrent psychiatric and medical conditions; and specific properties of the medication (e.g., half-life, actions on CYP isoenzymes, other drug interactions).a For most patients, an SSRI, SNRI, mirtazapine, or bupropion is considered optimal.a Consult APA’s Practice Guidelines for the Treatment of Patients with Major Depressive Disorder for additional information.a

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Obsessive-Compulsive Disorder (OCD)

Acute and maintenance treatment 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

Acute and maintenance treatment 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

Acute treatment 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 I disorder (bipolar depression).1 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, lamotrigine).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

Myoclonus

Has been used for management of intention myoclonus, including postanoxic action myoclonus and progressive action myoclonus in a limited number of patients.125

Premature Ejaculation

Like some other SSRIs, has been used for the treatment of premature ejaculation.393 394

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.1 (See Contraindications and also see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.)

  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 470 471 476 (See Worsening of Depression and Suicidality Risk under Cautions.)

  • Sustained therapy may be required; periodically reassess need for continued therapy.1

  • Avoid abrupt discontinuance.1 Taper dosage gradually and monitor for withdrawal symptoms.1 If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage, then resume more gradual dosage reductions.1 (See Withdrawal of Therapy under Cautions.)

  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 480 481 482 491 (See Pregnancy 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

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

Consider prolonged elimination half-life of fluoxetine and norfluoxetine (active metabolite) 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, should increase dosage after 1 week to 20 mg daily.1

Manufacturer states that both the initial and target dosage 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, should increase dosage 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

Optimal duration not established.1 If used for prolonged period, use minimum effective dosage and periodically reassess need for continued therapy.1 441

Adults

Major Depressive Disorder
Oral

As conventional capsules, tablets, or solution: Initially, 20 mg daily (in the morning).1 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 daily (in the morning).1 If no improvement is apparent after several weeks, dosage may be increased.1

Usual dosage: 20–60 mg daily; dosages ≤80 mg daily were well tolerated in clinical studies.1

Optimal duration not established.1 If used for prolonged period, use minimum effective dosage and periodically reassess need for continued therapy.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

Efficacy was maintained for periods of ≤12 months following 2 months of acute treatment in patients receiving 60 mg daily as conventional fluoxetine capsules.1 410 Most clinicians recommend continuing antidepressant therapy, including fluoxetine, for at least 6–12 months before attempting to discontinue therapy.355 410 If used for extended periods, periodically reassess need for continued therapy.1

Anorexia Nervosa
Oral

40 mg daily in weight-restored patients has been used.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

Optimal duration not established.1 435 If used for prolonged period, periodically reassess need for continued therapy.1

Bipolar Disorder
Monotherapy for Acute Depressive Episodes
Oral

20–60 mg daily in conjunction with a mood-stabilizing agent (e.g., lithium, lamotrigine).384 404

Combination Therapy for Acute Depressive Episodes
Oral

Fluoxetine/olanzapine (Symbyax): Initially, fluoxetine 25 mg and olanzapine 6 mg (Symbyax 6/25) once daily in the evening.448

Fluoxetine 25 mg and olanzapine 3–6 mg (Symbyax 3/25 or Symbyax 6/25) once daily in the evening as initial and maintenance therapy in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, those with a combination of factors that may slow metabolism of the drugs(s) (e.g., female gender, geriatric age, nonsmoking status), or those who may be pharmacodynamically sensitive to olanzapine; when indicated, escalate dosage with caution.448

In other patients, increase dosages of fluoxetine/olanzapine 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 >18 mg of olanzapine and 75 mg of fluoxetine not evaluated in clinical studies.1 448

When used with olanzapine as the single-ingredient components, administer the drugs once daily in the evening, usually initiating therapy with 5 mg of olanzapine and 20 mg of fluoxetine.1 May adjust dosage within the dosage ranges of 20–50 mg for fluoxetine and 5–12.5 mg for olanzapine.1 Use an initial dosage of 2.5–5 mg of olanzapine with fluoxetine 20 mg in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, those with a combination of factors that may slow metabolism of the drugs(s) (e.g., female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine; when indicated, escalate dosage increases with caution.1

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 has been used 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 dosage 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

Reduction in dosage and/or frequency not routinely necessary.1 Supplemental doses after hemodialysis not necessary.4 50

Geriatric Patients

Consider reducing dosage 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 are contraindicated within 5 weeks after discontinuance of fluoxetine.2 298 365 366 (See Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions and also see Interactions.)

  • Concurrent pimozide therapy.1

  • Concurrent thioridazine therapy.1 Thioridazine is contraindicated within 5 weeks after discontinuance of fluoxetine.1

Warnings/Precautions

Warnings

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.1 470 471 476 512 However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.1 470 471 476 514

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.1 470 471 476 512 (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.1 470 476 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.1 470 471 476 If decision is made to discontinue therapy, taper fluoxetine dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 470 (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 470

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) or nonpsychiatric disorders.1 470

Sensitivity Reactions

Allergic Reactions and Rash

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 or other possibly allergic manifestations for which an alternative etiology cannot be identified occur, discontinue therapy.1 2 22 217

Other Warnings and Precautions

Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions reported with SSRIs and SNRIs alone, including fluoxetine, but particularly with concurrent administration of other serotonergic drugs (e.g., 5-HT1 receptor agonists [triptans]), drugs that impair serotonin metabolism (e.g., MAO inhibitors), or antipsychotics or other dopamine antagonists.1 248 492 517 518 519 526 529 530 531 (See Contraindications under Cautions and also see Interactions.)

Symptoms of serotonin syndrome 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).1 492 517 518 519 529 530 531

Severe serotonin syndrome may resemble NMS, which is characterized by hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuations in vital signs, and mental status changes.1 517 518 519 529 530 531

Monitor patients receiving fluoxetine for the development of serotonin syndrome or NMS-like signs and symptoms.1 517 529 530 531 If such signs and symptoms occur, immediately discontinue treatment with fluoxetine and any concurrently administered serotonergic or antidopaminergic agents, including antipsychotic agents, and initiate supportive and symptomatic treatment.1 517 529 530

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

Bipolar Disorder

May unmask bipolar disorder.1 470 (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.1 470

Seizures

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

Altered Appetite and Weight

Possible anorexia and substantial weight loss, which may be undesirable in underweight or bulimic patients.1 2 15 60 61 63 65 66 67 69 72 122 161 176 Monitor weight change during fluoxetine therapy.1 (See Pediatric Use under Cautions.)

Abnormal Bleeding

Possible increased risk of bleeding with SSRIs, including fluoxetine, and SNRIs;1 events ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.1 329 452 453 454 455 456 458 Concomitant use of aspirin, NSAIAs, warfarin, or other anticoagulants may increase risk.1 (See Drugs Affecting Hemostasis and Specific Drugs under Interactions.)

Hyponatremia or SIADH

Treatment with SSRIs, including fluoxetine, and SNRIs may result in hyponatremia;1 90 280 524 527 528 529 530 531 in many cases, SIADH is apparent cause.1 90 280 281 529 530 531 Increased risk in patients who are volume depleted, elderly, or taking diuretics.1 90 281 524 529 530 531 Consider drug discontinuance and initiate appropriate medical intervention in patients with symptomatic hyponatremia.1 529 530 531

Anxiety and Insomnia

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

Concomitant Illnesses

Limited experience; use with caution in patients with concomitant illnesses affecting metabolism or hemodynamic response.1

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

May alter glycemic control in patients with diabetes mellitus.1 Hypoglycemia has occurred during fluoxetine therapy and hyperglycemia has developed following discontinuance of drug.1 Adjust insulin and/or oral antidiabetic agent dosage as necessary when initiating or discontinuing fluoxetine therapy.1

Mydriasis reported; use with caution in patients with elevated IOP or those at risk of acute narrow-angle glaucoma.1

Cognitive/Motor Impairment

Potential impairment of judgment, thinking, and motor skills.1 (See Advice to Patients.)

Long Elimination Half-Life

Because of the long elimination half-lives of fluoxetine and its major active metabolite, norfluoxetine, changes in dosage will take several weeks to be fully reflected in plasma concentrations, which affects dosage titration and withdrawal from treatment.1 2 3 48 50 52 53 56 217 Consider these potential consequences when drug discontinuance is required or when prescribing concurrent drugs that may interact with fluoxetine and norfluoxetine following fluoxetine discontinuance.1

Withdrawal of Therapy

Withdrawal effects (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances [e.g., paresthesias, such as electric shock sensations], anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania) reported following discontinuance of serotonergic antidepressants, particularly when discontinuance was abrupt.1 Events generally self-limiting, but serious cases reported.1

Taper dosage gradually; monitor patients for withdrawal symptoms when discontinuing therapy.1 If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage then resume more gradual dosage reductions.1

Use of Fixed Combinations

When fluoxetine is used in fixed combination with olanzapine, consider cautions, precautions, contraindications, and interactions associated with each drug.1 448

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT not systematically evaluated.1 4 Prolonged seizures reported rarely.1

Specific Populations

Pregnancy

Category C.1

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

Conflicting findings from available studies evaluating possible risk of persistent pulmonary hypertension of the newborn (PPHN) following in utero exposure to SSRIs; currently unclear whether SSRI use during pregnancy can cause PPHN.1 600 602 603 604 605 606 610

Consult joint APA and ACOG guidelines (at ) for additional information on management of depression in women prior to conception and during pregnancy, including treatment algorithms.600 608

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

Lactation

Distributed into milk; use not recommended.1

Pediatric Use

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

Safety and efficacy of fluoxetine in fixed combination with olanzapine not established in pediatric patients <18 years of age.1 448

Decreased appetite and weight loss observed with the use of SSRIs, including fluoxetine; monitor weight and growth regularly in children and adolescents treated with fluoxetine.1 (See Altered Appetite and Weight under Cautions.)

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment compared with placebo 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).1 470 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.1 470 512

Carefully consider these findings when assessing potential benefits and risks of fluoxetine in a child or adolescent for any clinical use.1 470 471 476 512 (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1 However, increased sensitivity cannot be ruled out.1

SNRIs and SSRIs, including fluoxetine, have been associated with clinically important hyponatremia in geriatric patients, who may be at greater risk for this adverse effect.1 90 281 524 525 529 530 531 (See Hyponatremia or SIADH under Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.470 471 (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 dosage and/or frequency.1 2 51 (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Anxiety, nervousness, insomnia, somnolence, asthenia, tremor, anorexia, nausea, dyspepsia, diarrhea, vasodilation, dry mouth, decreased libido, abnormal ejaculation, impotence, rash, sweating, abnormal dreams, flu syndrome, pharyngitis, sinusitis, yawning.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

When used in fixed combination with olanzapine, consider interactions associated with each drug in the fixed combination.448

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions) with serotonergic agents.1 283 299 300 301 303 492 Avoid such use, or use with caution.1 200 299 492 (See Contraindications and see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.)If serotonin syndrome or NMS occurs, immediately discontinue fluoxetine and any concurrently administered serotonergic agents or antidopaminergic agents and initiate supportive and symptomatic treatment.1

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: clinically important pharmacokinetic interaction unlikely.1

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis; use with caution.1 452 487 488 (See Abnormal Bleeding under Cautions.)

Protein-bound Drugs

Fluoxetine displaces and is displaced by protein-bound drugs.1 366 Monitor for possible adverse effects if used concomitantly with other protein-bound drugs.217

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 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, other SSRIs (e.g., citalopram, escitalopram, fluvoxamine, paroxetine, sertraline) or SNRIs (e.g., desvenlafaxine, duloxetine, milnacipran, venlafaxine)

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1

Concomitant use not recommended1

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

Antipsychotic agents (e.g., clozapine, haloperidol, olanzapine, pimozide, risperidone, thioridazine)

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1

Clozapine: Increased plasma clozapine concentrations1 366 396

Haloperidol: Increased plasma haloperidol concentrations;1 366 severe extrapyramidal symptoms have occurred118

Olanzapine: Increase in peak plasma olanzapine concentrations and decreased olanzapine clearance; unlikely to be clinically important1 533

Pimozide: Possible increased risk of QTc interval prolongation.1 Bradycardia, altered mental status (e.g., stupor, inability to think clearly), and/or hypersalivation reported rarely with concomitant use477 478 479

Risperidone: Possible increased risperidone plasma concentrations; tardive dyskinesia reported368

Thioridazine: Increased plasma thioridazine concentrations;365 serious ventricular arrhythmias and sudden death are possible1 365 366

If serotonin syndrome or NMS occurs, immediately discontinue fluoxetine and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment1

Clozapine: Use with caution, monitor closely, and consider decreasing clozapine dosage367

Olanzapine: No dosage adjustment necessary1

Pimozide: Concomitant use contraindicated1

Thioridazine: Concomitant use is contraindicated; an interval of >5 weeks should elapse between discontinuance of fluoxetine and initiation of thioridazine1

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

Diuretics

Increased risk of hyponatremia

Dopamine antagonists

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1

If serotonin syndrome or NMS occurs, immediately discontinue fluoxetine and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment1

5-HT1 receptor agonists (triptans)

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1 492

Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated1 366 492

If serotonin syndrome or NMS occurs, immediately discontinue fluoxetine and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment1

Isoniazid

Potential for serotonin syndrome304

Isoniazid has some MAO-inhibiting activity304

Linezolid

Potentially life-threatening serotonin syndrome or NMS-like reactions1 493 494 511 517 534 535 536 537 538 539

Do not use concurrently;493 consider availability of alternative anti-infectives and weigh benefit of linezolid against risk of serotonin syndrome493

If emergency use of linezolid is considered necessary, immediately discontinue fluoxetine; monitor closely for symptoms of CNS toxicity for 5 weeks or until 24 hours after the last linezolid dose, whichever comes first493

If nonemergency use of linezolid is planned, withhold fluoxetine for at least 5 weeks prior to initiating linezolid;493 fluoxetine may be resumed 24 hours after last linezolid dose493

Do not initiate fluoxetine in patients receiving linezolid; when necessary, initiate 24 hours after last linezolid dose493

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 serious, sometimes fatal serotonin syndrome or NMS-like reactions1 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

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 (no longer commercially available in US)

Possible serotonin syndrome492

Use with caution492

Stimulants (e.g., methylphenidate)

Potential serotonin syndrome392

Do not exceed maximum fluoxetine dosage of 20 mg daily392

Tramadol

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1

Use with caution1

If serotonin syndrome or NMS occurs, immediately discontinue fluoxetine and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment1

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

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1 2 3 100 303

Concomitant use not recommended1

Warfarin

Possible increased risk of bleeding1

Carefully monitor patients receiving warfarin during initiation and discontinuance of fluoxetine therapy1

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 delayed-release capsules, tablets, and oral solution are bioequivalent.1 495 542

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

Special Populations

In patients receiving hemodialysis, chronic administration produced steady-state plasma fluoxetine and norfluoxetine (active metabolite) concentrations comparable with those observed in patients with normal renal function.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 of fluoxetine.1

Elimination half-life of norfluoxetine 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 those of healthy individuals.1 51

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

Stability

Storage

Oral

Capsules, Conventional and Delayed-release

15–30°C; protect from light.1

Solution

20–25°C; protect from light.542

Tablets

20–25°C; protect from light.495

Actions

  • 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

  • Importance of providing copy of written patient information (medication guide) each time fluoxetine is dispensed.1 470 471 476 Importance of advising patients to read the patient information before taking fluoxetine and each time the prescription is filled.1

  • 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.1 470 471 476 (See Worsening of Depression and Suicidality Risk under Cautions.)

  • Importance of instructing patients not to take fluoxetine with an MAO inhibitor or within 14 days of stopping the MAO inhibitor, and not to take an MAO inhibitor within 5 weeks of stopping fluoxetine therapy.1

  • Importance of informing patients of potential risk of serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions, particularly with concurrent use of fluoxetine and 5-HT1 receptor agonists (also called triptans), tramadol, tryptophan, other serotonergic agents, or antipsychotic agents.1 492 Importance of immediately contacting clinician if signs and symptoms of these syndromes develop (e.g., restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, muscle stiffness, increased BP, diarrhea, coma, nausea, vomiting, confusion).1 492

  • Risk of allergic reactions and rash.1 Importance of advising patients to notify their clinician if they develop a rash or hives.1 Importance of also advising patients of the signs and symptoms associated with severe allergic reactions (e.g., swelling of the face, eyes, mouth; difficulty breathing) and to seek immediate medical attention if they experience these symptoms.1

  • Importance of informing patients that if they receive diuretics, or are otherwise volume-depleted, or are elderly, that they may be at greater risk of developing hyponatremia during fluoxetine 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 patients being aware that withdrawal effects may occur when stopping fluoxetine, especially with abrupt discontinuance of the drug.1

  • Risk of cognitive and motor impairment; importance of avoiding certain activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., Symbyax, Sarafem) and OTC drugs or herbal supplements 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 also informing clinicians if patients plan to discontinue any medications while receiving fluoxetine therapy.1

  • Importance of advising patients about the risk of bleeding or bruising associated with concomitant use of fluoxetine with aspirin or other NSAIAs, warfarin, or other drugs that affect coagulation.1 Importance of advising patients to inform their clinician if they experience any increased or unusual bruising or bleeding while receiving fluoxetine.1

  • 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)*

Fluoxetine Hydrochloride Capsules

Prozac Pulvules

Dista

Sarafem Pulvules

Lilly

20 mg (of fluoxetine)*

Fluoxetine Hydrochloride Capsules

Prozac Pulvules

Dista

Sarafem Pulvules

Lilly

40 mg (of fluoxetine)*

Fluoxetine Hydrochloride Capsules

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*

Fluoxetine Hydrochloride Oral Solution

Tablets

10 mg (of fluoxetine)*

Fluoxetine Hydrochloride Tablets

Sarafem

Warner Chilcott

15 mg (of fluoxetine)*

Sarafem

Warner Chilcott

20 mg (of fluoxetine)*

Fluoxetine Hydrochloride Tablets

Sarafem

Warner Chilcott

60 mg (of fluoxetine)*

Fluoxetine Hydrochloride Tablets

Fluoxetine Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

25 mg (of fluoxetine) with Olanzapine 3 mg

Symbyax (combination)

Lilly

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 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

FLUoxetine HCl 10MG Capsules (TEVA PHARMACEUTICALS USA): 30/$14.99 or 90/$26.97

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

FLUoxetine HCl 20MG Capsules (TEVA PHARMACEUTICALS USA): 30/$24.99 or 90/$50.97

FLUoxetine HCl 20MG/5ML Solution (PHARMACEUTICAL ASSOCIATES): 120/$19.99 or 360/$39.97

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

FLUoxetine HCl 40MG Capsules (PAR): 30/$40.99 or 90/$119.97

FLUoxetine HCl 90MG Delayed-release Capsules (DR.REDDY'S LABORATORIES): 4/$123.99 or 8/$245.97

FLUoxetine HCl (PMDD) 20MG Capsules (SANDOZ): 28/$39.99 or 84/$99.97

Prozac 10MG Capsules (DISTA): 30/$214.00 or 90/$592.96

PROzac 20MG Capsules (DISTA): 30/$218.99 or 90/$630.95

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

PROzac 40MG Capsules (DISTA): 30/$420.01 or 90/$1,218.94

PROzac Weekly 90MG Delayed-release Capsules (LILLY): 4/$153.99 or 12/$425.95

Sarafem 10MG Tablets (WARNER CHILCOTT PROF PROD DIV): 7/$66.99 or 21/$183.97

Sarafem 20MG Tablets (WARNER CHILCOTT PROF PROD DIV): 7/$66.99 or 21/$181.97

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

Symbyax 12-25MG Capsules (LILLY): 30/$719.99 or 90/$2,110.00

Symbyax 12-50MG Capsules (LILLY): 30/$651.97 or 90/$1,864.88

Symbyax 3-25MG Capsules (LILLY): 30/$345.99 or 90/$1,003.96

Symbyax 6-25MG Capsules (LILLY): 30/$453.99 or 90/$1,342.99

Symbyax 6-50MG Capsules (LILLY): 30/$480.97 or 90/$1,390.93

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 15, 2013. 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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