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Prozac Generic Name & Formulations
Legal Class
Rx
General Description
Fluoxetine (as HCl) 10mg, 20mg, 40mg; caps.
Pharmacological Class
SSRI.
How Supplied
Caps 10mg—100; 20mg—30, 100, 2000; 40mg—30; Tabs 60mg—30; Soln—contact supplier
Manufacturer
Generic Availability
YES
Prozac Indications
Indications
Panic disorder. Obsessive-compulsive disorder (OCD).
Prozac 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.
Prozac 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).
Prozac Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Prozac 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. 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.
Prozac Pharmacokinetics
See Literature
Prozac 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. Caution with concomitant triptans, tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort, linezolid, IV methylene blue; may cause serotonin syndrome. 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.
Prozac 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.
Prozac Clinical Trials
See Literature
Prozac Note
Not Applicable
Prozac Patient Counseling
See Literature
Prozac Generic Name & Formulations
Legal Class
Rx
General Description
Fluoxetine (as HCl) 10mg, 20mg, 40mg; caps.
Pharmacological Class
SSRI.
How Supplied
Caps 10mg—100; 20mg—30, 100, 2000; 40mg—30; Tabs 60mg—30; Soln—contact supplier
Manufacturer
Generic Availability
YES
Prozac 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).
Prozac 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.
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.
Prozac 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).
Prozac Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Prozac 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. 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.
Prozac Pharmacokinetics
See Literature
Prozac 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. Caution with concomitant triptans, tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's wort, linezolid, IV methylene blue; may cause serotonin syndrome. 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.
Prozac 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.
Prozac Clinical Trials
See Literature
Prozac Note
Not Applicable
Prozac Patient Counseling
See Literature
