Fluoxetine 60mg Tablets

— THERAPEUTIC CATEGORIES —
  • Anxiety/OCD
  • Mood disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Fluoxetine 60mg Tablets Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Fluoxetine (as HCl) 60mg; scored tabs.

    Pharmacological Class

    SSRI.

    See Also

    How Supplied

    Caps 10mg—100; 20mg—30, 100, 2000; 40mg—30; Tabs 60mg—30; Soln—contact supplier

    How Supplied

    Prozac is available in the following capsule strengths and packages:

    • 10 mg Pulvule is available in 100-count bottles. Each Pulvule is an opaque green cap and opaque green body, imprinted with “DISTA 3104” on the cap and “Prozac 10 mg” on the body.

    • 20 mg Pulvule is available in 30-, 100-, and 2000-count bottles. Each Pulvule is an opaque green cap and opaque yellow body, imprinted with “DISTA 3105” on the cap and “Prozac 20 mg” on the body.

    • 40 mg Pulvule is available in 30-count bottles. Each Pulvule is an opaque green cap and opaque orange body, imprinted with “DISTA 3107" on the cap and “Prozac 40 mg” on the body.

    Storage

    Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

    Manufacturer

    Alvogen

    Generic Availability

    YES

    Mechanism of Action

    Although, the exact mechanism of Prozac is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

    Fluoxetine 60mg Tablets Indications

    Indications

    Panic disorder. Obsessive-compulsive disorder (OCD).

    Fluoxetine 60mg Tablets Dosage and Administration

    Adult

    Panic disorder: initially 10mg/day in AM; increase after 1 week to 20mg/day; max 60mg/day. OCD: initially 20mg daily in AM; may give doses >20mg/day in 2 divided doses (AM and noon); max 80mg/day. Both: titrate over several weeks. Hepatic impairment (reduce dose); switching to or from MAOIs: see full labeling.

    Children

    <7yrs: not established. 7–17yrs: OCD: initially 10mg/day; may increase after 2 weeks to 20mg/day; range 20–60mg/day. Lower weight children: range 20–30mg/day.

    Elderly

    Consider a lower or less frequent dosage for the elderly.

    Hepatic Impairment

    Use a lower or less frequent dosage in patients with hepatic impairment.

    Other Modifications

    Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments.

    Fluoxetine 60mg Tablets Contraindications

    Contraindications

    Concomitant MAOIs during or within at least 5 weeks of discontinuing fluoxetine. Within 14 days of discontinuing an MAOI. Concomitant linezolid or IV methylene blue. Concomitant pimozide, thioridazine (may cause QTc prolongation).

    Fluoxetine 60mg Tablets Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Boxed Warning

    Suicidal thoughts and behaviors

    • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies. 

    • Advise families and caregivers of the need for close observation and communication with the prescriber. In patients of all ages who initiate treatment, monitor closely for worsening and for emergence of suicidal thoughts and behaviors.

    • Prozac is not approved for use in children less than 7 years of age.

    Fluoxetine 60mg Tablets Warnings/Precautions

    Warnings/Precautions

    Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for serotonin syndrome; discontinue if occurs. Discontinue if unexplained allergic reaction occurs. Renal or hepatic dysfunction. History of seizures or mania/hypomania. ECT (prolonged seizures). Congenital or history of long QT syndrome and other conditions (eg, hypokalemia, hypomagnesemia, recent MI, uncompensated heart failure, bradyarrhythmias, other significant arrhythmias); monitor ECG periodically. Reevaluate periodically in long-term use. Avoid abrupt cessation. Monitor weight. Conditions that affect metabolism or hemodynamic responses. Risk for bleeding events. Angle-closure glaucoma. Volume-depleted. Hyponatremia (esp. in elderly). Sexual dysfunction. Cardiovascular disease. Diabetes. History of drug abuse. Write ℞ for smallest practical amount. Elderly (consider lower or less frequent dose). Labor & delivery. Pregnancy (avoid 3rd trimester; see full labeling for effects on neonate). Nursing mothers: monitor infants.

    Warnings/Precautions

    Suicidal Thoughts and Behaviors in Adolescents and Young Adults

    • The risk of suicidal thoughts and behaviors in children, adolescents, and young adults is unknown with long-term use (eg, beyond several months).

    • Monitor all patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months and at times of dosage changes.

    • Counsel caregivers or family members to monitor for changes in behavior and to alert the healthcare provider.

    • If depression is persistently worse or who are experiencing emergent suicidal thoughts or behaviors, consider changing the therapeutic regimen, including discontinuing treatment.

    • Prescribe Prozac for the smallest quantity of capsules consistent with good patient management.

    Serotonin Syndrome

    • See Interactions.

    • Risk of life-threatening serotonin syndrome: increased risk when Prozac is used concomitantly with other serotonergic drugs (including triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and drugs that impair metabolism of serotonin (eg, MAOIs).

    • Do not initiate in patients who are being treated with MAOIs (eg, linezolid or IV methylene blue). If concomitant use is necessary with an MAOI, discontinue Prozac before initiation of MAOI.

    • Monitor for emergence of serotonin syndrome.

    • Discontinue immediately if serotonin syndrome occurs and initiate supportive symptomatic treatment.

    Allergic Reactions and Rash

    • Discontinue Prozac upon appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified.

    Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania

    • Prior to initiating treatment, screen patients with depressive symptoms to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

    Seizures

    • Use caution in patients with a history of seizures.

    Altered Appetite and Weight

    • Monitor weight change during treatment.

    Abnormal Bleeding

    • Increased risk for bleeding reactions. Concomitant use with aspirin, NSAIDs, warfarin, and other anticoagulants known to affect platelet function may increase the risk of bleeding.

    • Advise patients about the increased risk of bleeding when Prozac is coadministered with NSAIDs, aspirin, warfarin or other drugs. 

    Angle-Closure Glaucoma 

    • Prozac may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

    Hyponatremia

    • Greater risk of developing hyponatrema with SNRIs in elderly patients, patients taking diuretics, or those who are otherwise volume-depleted.

    • Consider discontinuing treatment with Prozac in patients with symptomatic hyponatremia, and institute appropriate medical intervention.

    QT Prolongation

    • Use caution in patients with congenital or history of long QT syndrome and other conditions (eg, hypokalemia, hypomagnesemia, recent MI, uncompensated heart failure, bradyarrhythmias, other significant arrhythmias); monitor ECG periodically.

    Use in Patients with Concomitant Illness

    • Caution is advisable in using Prozac in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

    • Prozac has not been evaluated in patients with a recent history of MI or unstable heart disease.

    • Prozac may alter glycemic control in patients with diabetes. May need to adjust dose of Prozac when used in patients with diabetes.

    Potential for Cognitive and Motor Impairment

    • Use caution when operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

    Discontinuation Adverse Reactions

    • Adverse reactions upon discontinuing Prozac, SNRIs, and SSRIs are the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania.

    • Monitor for these symptoms when discontinuing treatment. Gradually reducing dose is recommended whenever possible rather than abrupt cessation. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. 

    Sexual Dysfunction

    • SSRIs, including Prozac, may cause symptoms of sexual dysfunction.

    • Prescribers should inquire about sexual function prior to initiation and about changes in sexual function during treatment.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    Risk Summary 

    • Available data from published epidemiologic studies and postmarketing reports have not identified an increased risk of major birth defects or miscarriage.

    • There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including Prozac, during pregnancy.

    Clinical Considerations

    • Disease-Associated Maternal and/or Embryo/Fetal Risk: Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

    • Fetal/Neonatal Adverse Reactions: Neonates exposed to Prozac and other SSRI or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. 

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Prozac and any potential adverse effects on the breastfed child or from the underlying maternal condition.

    Clinical Considerations

    • Monitor infants exposed to Prozac for agitation, irritability, poor feeding, and poor weight gain.

    Pediatric Considerations

    The safety and effectiveness in pediatric patients <8 years of age in major depressive disorder and <7 years of age in OCD have not been established.

    Use of Prozac in combination with olanzapine in children and adolescents: Safety and efficacy of Prozac and olanzapine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar i disorder. 

    Safety and effectiveness of Prozac and olanzapine in combination in patients less than 10 years of age have not been established.

    Hepatic Impairment Considerations

    Caution is advised when using Prozac in patients with diseases or conditions that could affect its metabolism.

    Fluoxetine 60mg Tablets Pharmacokinetics

    Absorption

    Peak plasma concentrations of 15–55 ng/mL are observed after 6 to 8 hours following a single oral 40 mg dose.

    Distribution

    In vitro plasma protein bound: ~94.5% (including albumin and α1-glycoprotein).

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life (fluoxetine): 1–3 days (acute); 4–6 days (chronic). Half-life (norfluoxetine): 4–16 days.

    Fluoxetine 60mg Tablets Interactions

    Interactions

    See Contraindications. Do not start with concomitant linezolid or IV methylene blue; if treatment is necessary, discontinue fluoxetine before starting; monitor for serotonin syndrome for 5 weeks or until 24 hours after last dose of linezolid or IV methylene blue, whichever comes first. Do not start thioridazine within at least 5 weeks of discontinuing fluoxetine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue); monitor. Avoid concomitant drugs known to prolong the QT interval (eg, ziprasidone, iloperidone, chlorpromazine, erythromycin, gatifloxacin, Class IA & III antiarrhythmics, pentamidine, methadone, and others. May potentiate protein-bound drugs (eg, warfarin, digoxin) and those metabolized by CYP2D6 (eg, tricyclics, vinblastine, flecainide). May potentiate carbamazepine, phenytoin. Monitor lithium, phenytoin, warfarin, tricyclics. Caution with benzodiazepines (eg, diazepam, alprazolam), antipsychotics (eg, clozapine, haloperidol), other CNS drugs. Increased risk of bleeding with NSAIDs, aspirin, warfarin, others that affect coagulation. Hyponatremia with diuretics.

    Fluoxetine 60mg Tablets Adverse Reactions

    Adverse Reactions

    CNS stimulation (eg, anxiety, nervousness, insomnia, abnormal dreams), anorexia, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, respiratory symptoms, rash (may be serious), somnolence, sweating, tremor, vasodilatation, yawn; mania/hypomania, weight loss, motor impairment, serum sickness, hypo- or hyperglycemia, urticaria, pruritus. Children: thirst, hyperkinesia, agitation, personality disorder, epistaxis, urinary frequency, menorrhagia.

    Fluoxetine 60mg Tablets Clinical Trials

    Clinical Trials

    Obsessive Compulsive Disorder

    Adult

    • In two 13-week, multicenter, parallel group studies (Study 1 and 2), the efficacy of Prozac was evaluated in adult outpatients with moderate to severe OCD. Patients received fixed doses of Prozac 20, 40, or 60mg/day (on a once-a-day schedule, in the morning) or placebo.

    • In Study 1, patients treated with Prozac achieved mean reductions of approximately 4 to 6 units on the Yale-Brown Obsessive Compulsive Scale (YBOCS) total score compared with a 1-unit reduction for placebo patients.

    • In Study 2, patients treated with Prozac achieved mean reductions of approximately 4 to 9 units on the YBOCS total score compared with a 1-unit reduction for placebo patients. 

    Pediatric (Children and Adolescents)

    • In one 13-week clinical trial, 103 pediatric patients received Prozac 10mg/day for 2 weeks followed by 20mg/day for 2 weeks. Treatment with Prozac achieved a statistically significantly greater mean change from baseline to endpoint than did placebo as measured by the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS). 

     

    Panic Disorder

    Two double-blind, randomized, placebo-controlled, multicenter studies evaluated the effectiveness of Prozac for the treatment of adult outpatients who had a primary diagnosis of panic disorder (DSM-IV), with or without agoraphobia. 

    In Study 1 (N=180 randomized), Prozac was initiated at 10 mg/day for the first week, after which patients were dosed in the range of 20 to 60 mg/day on the basis of clinical response and tolerability. A statistically significantly greater percentage of Prozac-treated patients were free from panic attacks at endpoint than placebo-treated patients, 42% versus 28%, respectively. 

    In Study 2 (N=214 randomized), Prozac was initiated at 10 mg/day for the first week, after which patients were dosed in a range of 20 to 60 mg/day on the basis of clinical response and tolerability. A statistically significantly greater percentage of Prozac-treated patients were free from panic attacks at endpoint than placebo-treated patients, 62% versus 44%, respectively.

    Fluoxetine 60mg Tablets Note

    Not Applicable

    Fluoxetine 60mg Tablets Patient Counseling

    See Literature

    Fluoxetine 60mg Tablets Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Fluoxetine (as HCl) 60mg; scored tabs.

    Pharmacological Class

    SSRI.

    See Also

    How Supplied

    Caps 10mg—100; 20mg—30, 100, 2000; 40mg—30; Tabs 60mg—30; Soln—contact supplier

    How Supplied

    Prozac is available in the following capsule strengths and packages:

    • 10 mg Pulvule is available in 100-count bottles. Each Pulvule is an opaque green cap and opaque green body, imprinted with “DISTA 3104” on the cap and “Prozac 10 mg” on the body.

    • 20 mg Pulvule is available in 30-, 100-, and 2000-count bottles. Each Pulvule is an opaque green cap and opaque yellow body, imprinted with “DISTA 3105” on the cap and “Prozac 20 mg” on the body.

    • 40 mg Pulvule is available in 30-count bottles. Each Pulvule is an opaque green cap and opaque orange body, imprinted with “DISTA 3107" on the cap and “Prozac 40 mg” on the body.

    Storage

    Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

    Manufacturer

    Alvogen

    Generic Availability

    YES

    Mechanism of Action

    Although, the exact mechanism of Prozac is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin.

    Fluoxetine 60mg Tablets Indications

    Indications

    Monotherapy: major depressive disorder (MDD); or bulimia nervosa. In combination with olanzapine: depressive episodes associated with bipolar disorder, or treatment resistant depression (TRD; see full labeling).

    Indications

    Monotherapy:

    • Acute and maintenance treatment of major depressive disorder (MDD)

    • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa

    In combination with olanzapine:

    • Acute treatment of depressive episodes associated with bipolar disorder

    • Treatment resistant depression (MDD in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).

    Prozac monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

    Fluoxetine 60mg Tablets Dosage and Administration

    Adult

    MDD: initially 20mg daily in AM; increase if needed after several weeks. May give doses >20mg/day in 2 divided doses (AM and noon); max 80mg/day. Bulimia: 60mg once daily in the AM; may titrate to this target dose over several days; max 60mg/day. Bipolar depression: initially olanzapine 5mg + fluoxetine 20mg once daily in the PM; range: olanzapine 5–12.5mg + fluoxetine 20–50mg. TRD: initially olanzapine 5mg + fluoxetine 20mg once daily in the PM; range: olanzapine 5–20mg + fluoxetine 20–50mg. For bipolar depression, TRD: doses > olanzapine 18mg + fluoxetine 75mg: not studied. Risk of hypotension, hepatic impairment, slow metabolizers, or sensitive to olanzapine: initially olanzapine 2.5–5mg + fluoxetine 20mg; increase cautiously. Hepatic impairment (reduce dose), dose adjustments; switching to or from MAOIs: see full labeling.

    Adult

    Major Depressive Disorder 

    Initial Treatment

    • Initially 20mg daily in the morning. Consider increasing dose after several weeks if insufficient clinical improvement is observed. May give doses above 20mg/day in 2 divided doses (AM and noon). The maximum dose should not exceed 80mg/day.

    • The full effect may be delayed until 4 weeks of treatment or longer.

    • Switching Patients to a Tricyclic Antidepressant (TCA): May need to reduce dose of TCA, and may need to temporarily monitor plasma TCA concentrations when fluoxetine is coadministered or has been recently discontinued.

    • Switching Patients To and From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders:  At least 14 days should elapse between discontinuation of an MAOI and initiating Prozac. At least 5 weeks should elapse between discontinuing Prozac and initiating MAOI. Do not initiate Prozac if the patient is being treated with linezolid or IV methylene blue because of an increased risk for serotonin syndrome.

    Bulimia Nervosa

    Initial Treatment

    • Give 60mg once daily in the morning. For certain patients, it may be advisable to titrate up to this target dose over several days.

    • Fluoxetine doses >60mg/day have not been studied. Periodically reassess to determine the need for maintenance treatment.

    • Switching Patients To and From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders:  At least 14 days should elapse between discontinuation of an MAOI and initiating Prozac. At least 5 weeks should elapse between discontinuing Prozac and initiating MAOI. Do not initiate Prozac if the patient is being treated with linezolid or IV methylene blue because of an increased risk for serotonin syndrome.

    In Combination with Olanzapine: Depressive Episodes Associated with Bipolar Disorder

    • Initially olanzapine 5mg + fluoxetine 20mg once daily in the PM.

    • Make dose adjustments, if indicated based on efficacy and tolerability within dose ranges of olanzapine 5–12.5mg + fluoxetine 20–50mg. 

    • The safety of co-administration of doses above olanzapine 18mg with fluoxetine 75mg has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.

    • Use a starting dose of olanzapine 2.5–5mg + fluoxetine 20mg for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dose.

    • Prozac monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

    • Switching Patients To and From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders:  At least 14 days should elapse between discontinuation of an MAOI and initiating Prozac. At least 5 weeks should elapse between discontinuing Prozac and initiating MAOI. Do not initiate Prozac if the patient is being treated with linezolid or IV methylene blue because of an increased risk for serotonin syndrome.

    In Combination with Olanzapine: Treatment-Resistant Depression

    • Initially olanzapine 5mg + fluoxetine 20mg once daily in the PM.

    • Make dose adjustments, if indicated based on efficacy and tolerability within dose ranges of olanzapine 5–12.5mg + fluoxetine 20–50mg. 

    • The safety of co-administration of doses above olanzapine 18mg with fluoxetine 75mg has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.

    • Use a starting dose of olanzapine 2.5–5mg + fluoxetine 20mg for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, non-smoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dose.

    • Prozac monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.

    • Switching Patients To and From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders:  At least 14 days should elapse between discontinuation of an MAOI and initiating Prozac. At least 5 weeks should elapse between discontinuing Prozac and initiating MAOI. Do not initiate Prozac if the patient is being treated with linezolid or IV methylene blue because of an increased risk for serotonin syndrome.

    Children

    MDD: <8yrs: not established. 8–18yrs: initially 10mg or 20mg/day; if started on 10mg/day, increase after 1 week to 20mg/day. Lower weight children: start at 10mg/day; may increase after several weeks to 20mg/day. Bipolar depression: <10yrs: not established. 10–17yrs: initially olanzapine 2.5mg + fluoxetine 20mg once daily in the PM; adjust as needed. Doses > olanzapine 12mg + fluoxetine 50mg: not studied.

    Children

    Major Depressive Disorder

    • <8yrs: not established. 

    • 8–18yrs: Initially 10mg or 20mg/day. After 1 week on 10mg/day, increase to 20mg/day. Due to higher plasma levels in lower weight children, the starting and target dose may be 10mg/day. Consider dose increase to 20mg/day after several weeks if insufficient clinical improvement is observed.

    • The full effect may be delayed until 4 weeks of treatment or longer.

    • Switching Patients To and From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders:  At least 14 days should elapse between discontinuation of an MAOI and initiating Prozac. At least 5 weeks should elapse between discontinuing Prozac and initiating MAOI. Do not initiate Prozac if the patient is being treated with linezolid or IV methylene blue because of an increased risk for serotonin syndrome.

    In Combination with Olanzapine: Depressive Episodes Associated with Bipolar Disorder

    • <10yrs: not established.

    • 10–17yrs: Initially olanzapine 2.5mg + fluoxetine 20mg once daily in the PM.

    • The safety of co-administration of doses above olanzapine 12mg with fluoxetine 50mg has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.

    • Switching Patients To and From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders:  At least 14 days should elapse between discontinuation of an MAOI and initiating Prozac. At least 5 weeks should elapse between discontinuing Prozac and initiating MAOI. Do not initiate Prozac if the patient is being treated with linezolid or IV methylene blue because of an increased risk for serotonin syndrome.

    Elderly

    Consider a lower or less frequent dosage for the elderly.

    Hepatic Impairment

    Use a lower or less frequent dosage in patients with hepatic impairment.

    Other Modifications

    Patients with concurrent disease or on multiple concomitant medications may require dosage adjustments.

    Fluoxetine 60mg Tablets Contraindications

    Contraindications

    Concomitant MAOIs during or within at least 5 weeks of discontinuing fluoxetine. Within 14 days of discontinuing an MAOI. Concomitant linezolid or IV methylene blue. Concomitant pimozide, thioridazine (may cause QTc prolongation).

    Fluoxetine 60mg Tablets Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Boxed Warning

    Suicidal thoughts and behaviors

    • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies. 

    • Advise families and caregivers of the need for close observation and communication with the prescriber. In patients of all ages who initiate treatment, monitor closely for worsening and for emergence of suicidal thoughts and behaviors.

    • Prozac is not approved for use in children less than 7 years of age.

    Fluoxetine 60mg Tablets Warnings/Precautions

    Warnings/Precautions

    Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for serotonin syndrome; discontinue if occurs. Discontinue if unexplained allergic reaction occurs. Renal or hepatic dysfunction. History of seizures or mania/hypomania. ECT (prolonged seizures). Congenital or history of long QT syndrome and other conditions (eg, hypokalemia, hypomagnesemia, recent MI, uncompensated heart failure, bradyarrhythmias, other significant arrhythmias); monitor ECG periodically. Reevaluate periodically in long-term use. Avoid abrupt cessation. Monitor weight. Conditions that affect metabolism or hemodynamic responses. Risk for bleeding events. Angle-closure glaucoma. Volume-depleted. Hyponatremia (esp. in elderly). Sexual dysfunction. Cardiovascular disease. Diabetes. History of drug abuse. Write ℞ for smallest practical amount. Elderly (consider lower or less frequent dose). Labor & delivery. Pregnancy (avoid 3rd trimester; see full labeling for effects on neonate). Nursing mothers: monitor infants.

    Warnings/Precautions

    Suicidal Thoughts and Behaviors in Adolescents and Young Adults

    • The risk of suicidal thoughts and behaviors in children, adolescents, and young adults is unknown with long-term use (eg, beyond several months).

    • Monitor all patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months and at times of dosage changes.

    • Counsel caregivers or family members to monitor for changes in behavior and to alert the healthcare provider.

    • If depression is persistently worse or who are experiencing emergent suicidal thoughts or behaviors, consider changing the therapeutic regimen, including discontinuing treatment.

    • Prescribe Prozac for the smallest quantity of capsules consistent with good patient management.

    Serotonin Syndrome

    • See Interactions.

    • Risk of life-threatening serotonin syndrome: increased risk when Prozac is used concomitantly with other serotonergic drugs (including triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and drugs that impair metabolism of serotonin (eg, MAOIs).

    • Do not initiate in patients who are being treated with MAOIs (eg, linezolid or IV methylene blue). If concomitant use is necessary with an MAOI, discontinue Prozac before initiation of MAOI.

    • Monitor for emergence of serotonin syndrome.

    • Discontinue immediately if serotonin syndrome occurs and initiate supportive symptomatic treatment.

    Allergic Reactions and Rash

    • Discontinue Prozac upon appearance of rash or of other possibly allergic phenomena for which an alternative etiology cannot be identified.

    Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania

    • Prior to initiating treatment, screen patients with depressive symptoms to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

    Seizures

    • Use caution in patients with a history of seizures.

    Altered Appetite and Weight

    • Monitor weight change during treatment.

    Abnormal Bleeding

    • Increased risk for bleeding reactions. Concomitant use with aspirin, NSAIDs, warfarin, and other anticoagulants known to affect platelet function may increase the risk of bleeding.

    • Advise patients about the increased risk of bleeding when Prozac is coadministered with NSAIDs, aspirin, warfarin or other drugs. 

    Angle-Closure Glaucoma 

    • Prozac may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

    Hyponatremia

    • Greater risk of developing hyponatrema with SNRIs in elderly patients, patients taking diuretics, or those who are otherwise volume-depleted.

    • Consider discontinuing treatment with Prozac in patients with symptomatic hyponatremia, and institute appropriate medical intervention.

    QT Prolongation

    • Use caution in patients with congenital or history of long QT syndrome and other conditions (eg, hypokalemia, hypomagnesemia, recent MI, uncompensated heart failure, bradyarrhythmias, other significant arrhythmias); monitor ECG periodically.

    Use in Patients with Concomitant Illness

    • Caution is advisable in using Prozac in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

    • Prozac has not been evaluated in patients with a recent history of MI or unstable heart disease.

    • Prozac may alter glycemic control in patients with diabetes. May need to adjust dose of Prozac when used in patients with diabetes.

    Potential for Cognitive and Motor Impairment

    • Use caution when operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not affect them adversely.

    Discontinuation Adverse Reactions

    • Adverse reactions upon discontinuing Prozac, SNRIs, and SSRIs are the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania.

    • Monitor for these symptoms when discontinuing treatment. Gradually reducing dose is recommended whenever possible rather than abrupt cessation. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. 

    Sexual Dysfunction

    • SSRIs, including Prozac, may cause symptoms of sexual dysfunction.

    • Prescribers should inquire about sexual function prior to initiation and about changes in sexual function during treatment.

    Pregnancy Considerations

    Pregnancy Exposure Registry 

    Risk Summary 

    • Available data from published epidemiologic studies and postmarketing reports have not identified an increased risk of major birth defects or miscarriage.

    • There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs), including Prozac, during pregnancy.

    Clinical Considerations

    • Disease-Associated Maternal and/or Embryo/Fetal Risk: Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

    • Fetal/Neonatal Adverse Reactions: Neonates exposed to Prozac and other SSRI or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. 

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Prozac and any potential adverse effects on the breastfed child or from the underlying maternal condition.

    Clinical Considerations

    • Monitor infants exposed to Prozac for agitation, irritability, poor feeding, and poor weight gain.

    Pediatric Considerations

    The safety and effectiveness in pediatric patients <8 years of age in major depressive disorder and <7 years of age in OCD have not been established.

    Use of Prozac in combination with olanzapine in children and adolescents: Safety and efficacy of Prozac and olanzapine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar i disorder. 

    Safety and effectiveness of Prozac and olanzapine in combination in patients less than 10 years of age have not been established.

    Hepatic Impairment Considerations

    Caution is advised when using Prozac in patients with diseases or conditions that could affect its metabolism.

    Fluoxetine 60mg Tablets Pharmacokinetics

    Absorption

    Peak plasma concentrations of 15–55 ng/mL are observed after 6 to 8 hours following a single oral 40 mg dose.

    Distribution

    In vitro plasma protein bound: ~94.5% (including albumin and α1-glycoprotein).

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life (fluoxetine): 1–3 days (acute); 4–6 days (chronic). Half-life (norfluoxetine): 4–16 days.

    Fluoxetine 60mg Tablets Interactions

    Interactions

    See Contraindications. Do not start with concomitant linezolid or IV methylene blue; if treatment is necessary, discontinue fluoxetine before starting; monitor for serotonin syndrome for 5 weeks or until 24 hours after last dose of linezolid or IV methylene blue, whichever comes first. Do not start thioridazine within at least 5 weeks of discontinuing fluoxetine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue); monitor. Avoid concomitant drugs known to prolong the QT interval (eg, ziprasidone, iloperidone, chlorpromazine, erythromycin, gatifloxacin, Class IA & III antiarrhythmics, pentamidine, methadone, and others. May potentiate protein-bound drugs (eg, warfarin, digoxin) and those metabolized by CYP2D6 (eg, tricyclics, vinblastine, flecainide). May potentiate carbamazepine, phenytoin. Monitor lithium, phenytoin, warfarin, tricyclics. Caution with benzodiazepines (eg, diazepam, alprazolam), antipsychotics (eg, clozapine, haloperidol), other CNS drugs. Increased risk of bleeding with NSAIDs, aspirin, warfarin, others that affect coagulation. Hyponatremia with diuretics.

    Fluoxetine 60mg Tablets Adverse Reactions

    Adverse Reactions

    CNS stimulation (eg, anxiety, nervousness, insomnia, abnormal dreams), anorexia, asthenia, diarrhea, dry mouth, dyspepsia, flu syndrome, respiratory symptoms, rash (may be serious), somnolence, sweating, tremor, vasodilatation, yawn; mania/hypomania, weight loss, motor impairment, serum sickness, hypo- or hyperglycemia, urticaria, pruritus. Children: thirst, hyperkinesia, agitation, personality disorder, epistaxis, urinary frequency, menorrhagia.

    Fluoxetine 60mg Tablets Clinical Trials

    Clinical Trials

    Major Depressive Disorder

    Daily Dosing – Adult

    • The efficacy of Prozac was studied in 5- and 6-week placebo-controlled trials with depressed adult and geriatric outpatients (≥18 years of age) whose diagnoses corresponded most closely to the DSM-III (currently DSM-IV) category of major depressive disorder (MDD). Prozac was shown to be significantly more effective than placebo as measured by the Hamilton Depression Rating Scale (HAM-D). PROZAC was also significantly more effective than placebo on the HAM-D subscores for depressed mood, sleep disturbance, and the anxiety subfactor.

    • In two 6-week controlled studies, the efficacy of Prozac 20mg was compared to placebo in 671 elderly patients with MDD. Treatment with Prozac 20mg achieved a significantly higher rate of response and remission as defined, respectively, by a 50% decrease in the HAM-D score and a total endpoint HAM-D score of ≤8.

    Daily Dosing – Pediatric (children and adolescents)

    • In two  8- to 9-week placebo-controlled trials, the efficacy of Prozac 20mg/day was evaluated in children and adolescents who were depressed and diagnosed corresponding most closely to the DSM-III-R or DSM-IV category of MDD. Both studies showed that Prozac achieved a statistically significantly greater mean change on the Childhood Depression Rating Scale-Revised (CDRS-R) total score from baseline to endpoint than did placebo.

    Maintenance Treatment

    • A study was conducted involving depressed outpatients who had responded (modified HAMD-17 score of ≤7 during each of the last 3 weeks of open-label treatment and absence of MDD by DSM-III-R criteria) by the end of an initial 12-week open-treatment phase on Prozac 20 mg/day. These patients (N=298) were randomized to continuation on double-blind Prozac 20 mg/day or placebo. At 38 weeks (50 weeks total), a statistically significantly lower relapse rate (defined as symptoms sufficient to meet a diagnosis of MDD for 2 weeks or a modified HAMD-17 score of ≥14 for 3 weeks) was observed for patients taking Prozac compared with those on placebo. 

    • An additional maintenance study was conducted involving adult outpatients meeting DSM-IV criteria for MDD who had responded (defined as having a modified HAMD-17 score of ≤9, a CGI-Severity rating of ≤2, and no longer meeting criteria for Major Depressive Disorder) for 3 consecutive weeks at the end of 13 weeks of open-label treatment with Prozac 20 mg once daily. These patients were randomized to double-blind, once-weekly continuation treatment with fluoxetine delayed-release capsules 90 mg once weekly, Prozac 20 mg once daily, or placebo. Prozac 20 mg once daily demonstrated superior efficacy (having a significantly longer time to relapse of depressive symptoms) compared with placebo for a period of 25 weeks.

     

    Bulimia Nervosa

    The efficacy of Prozac for the treatment of bulimia was demonstrated in two 8-week and one 16-week, multicenter, parallel group studies of adult outpatients meeting DSM-III-R criteria for moderate to severe bulimia. In the 8-week studies, patients received either 20 or 60 mg/day of Prozac or placebo in the morning. In the 16-week study, patients received a fixed dose of Prozac 60 mg/day.

    • Results from the 3 studies showed that treatment with Prozac 60 mg was statistically significantly superior to placebo in reducing the number of binge-eating and vomiting episodes per week. This effect was present as early as Week 1 and persisted throughout each study. The reduction in the frequency of bulimic behaviors ranged from 1 to 2 episodes per week for binge-eating and 2 to 4 episodes per week for vomiting.

    In a longer-term trial, 150 patients meeting DSM-IV criteria for Bulimia Nervosa, purging subtype, who had responded during a single-blind, 8-week acute treatment phase with Prozac 60 mg/day, were randomized to continuation of Prozac 60 mg/day or placebo, for up to 52 weeks of observation for relapse. Response during the single-blind phase was defined by having achieved at least a 50% decrease in vomiting frequency compared with baseline. Patients receiving continued Prozac 60 mg/day experienced a significantly longer time to relapse over the subsequent 52 weeks compared with those receiving placebo.

    Fluoxetine 60mg Tablets Note

    Not Applicable

    Fluoxetine 60mg Tablets Patient Counseling

    See Literature

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