Uses
Major Depressive Disorder
Management of major depressive disorder.
Efficacy in hospital settings not established.
Obsessive-Compulsive Disorder (OCD)
Management of OCD.
Premenstrual Dysphoric Disorder (PMDD)
Management of PMDD (previously late luteal phase dysphoric disorder).
Eating Disorders
Management of moderate to severe bulimia nervosa (at least 3 bulimic episodes per week for 6 months).
SSRIs usually are preferred drugs in management of bulimia because of more favorable adverse effect profile.
Also has been used for management of anorexia nervosa†.
Not recommended as the sole or primary treatment of anorexia nervosa†.
Panic Disorder
Management of panic disorder with or without agoraphobia.
Bipolar Disorder
Short-term treatment of acute depressive episodes (alone† or in combination with olanzapine) in patients with bipolar disorder (bipolar depression).
May cause manic reactions when used as monotherapy in some patients; should not be used without mood stabilizing agents (e.g., lithium).
Obesity
Has been used for the short-term treatment of exogenous obesity†.
Cataplexy
Has been used for the symptomatic management of cataplexy† in a limited number of patients with cataplexy and associated narcolepsy.
Alcohol Dependence
Has been used in the management of alcohol dependence†.
Studies of SSRIs have generally shown modest effects on alcohol consumption.
Dosage and Administration
General
- Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of fluoxetine, and at least 5 weeks to elapse between discontinuance of fluoxetine and initiation of an MAO inhibitor or thioridazine therapy.
- Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
- Sustained therapy may be required; use lowest effective dosage and periodically reassess need for continued therapy.
- Avoid abrupt discontinuance of therapy. To avoid withdrawal reactions, taper dosage gradually. (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
- Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Administration
Oral Administration
Administer conventional capsules, tablets, and solution orally once (in the morning) or twice daily (preferably in the morning and at noon) without regard to meals. If sedation occurs, the second dose may be administered at bedtime.
Administer delayed-release preparation once weekly without regard to meals.
Administer fixed-combination fluoxetine/olanzapine capsules (Symbyax®) once daily in the evening.
Dosage
Available as fluoxetine hydrochloride; dosage is expressed in terms of fluoxetine.
Consider prolonged elimination half-life of fluoxetine and norfluoxetine when titrating dosage or discontinuing therapy. Several weeks may be required before full effect of dosage alterations is realized.
Pediatric Patients
Major Depressive Disorder
Oral
Children and adolescents ≥8 years of age: initially, 10 or 20 mg daily. If therapy is initiated at 10 mg daily, it can be increased after 1 week to 20 mg daily.
Manufacturer states that both the initial and target dose in lower weight children may be 10 mg daily.
An increase in dosage to 20 mg daily may be considered after several weeks in lower weight children if insufficient clinical improvement is observed.
Obsessive-Compulsive Disorder
Oral
Children and adolescents ≥7 years of age: initially, 10 mg daily.
In adolescents and higher weight children, the dosage should be increased to 20 mg daily after 2 weeks; additional dosage increases may be considered after several more weeks if insufficient clinical improvement is observed.
In lower weight children, dosage increases may be considered after several weeks if insufficient clinical improvement is observed.
Usual dosages: 20–60 mg daily for adolescents and higher weight children or 20–30 mg daily for lower weight children.
Adults
Major Depressive Disorder
Oral
As conventional capsules, tablets, or solution: Initially, 20 mg once daily (in the morning). May initiate with lower dosage (e.g., 5 mg daily, 20 mg every 2–3 days). If no improvement is apparent after several weeks of therapy with 20 mg daily, an increase in dosage may be considered.
Usual dosage: 10–80 mg daily.
Delayed-release capsules: 90 mg once weekly, beginning 7 days after the last 20 mg daily dose as conventional capsules, tablets, or solution.
If a satisfactory response is not maintained, consider reestablishing daily dosage regimen with conventional capsules, tablets, or solution.
Optimum duration not established; may require several months of therapy or longer.
Obsessive-Compulsive Disorder
Oral
Initially, 20 mg once daily. If no improvement is apparent after several weeks, dosage may be increased.
Usual dosage: 20–60 mg daily.
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).
If the intermittent dosing regimen is used, it should be repeated with each new menstrual cycle.
Eating Disorders
Bulimia Nervosa
Oral
60 mg daily (in the morning); dosage may be decreased as necessary to minimize adverse effects. Alternatively, dosage may be titrated up to recommended initial dosage over several days.
Anorexia Nervosa
Oral
40 mg daily in weight-restored patients.†
Panic Disorder
Oral
Initially, 10 mg daily. Increase dosage after 1 week to 20 mg daily. 10–60 mg is effective; 20 mg daily most frequently used. Dosages >60 mg daily not systematically evaluated.
Bipolar Disorder
Monotherapy
Oral
20–60 mg daily in conjunction with a mood-stabilizing agent (e.g., lithium).†
Combination Therapy
Oral
Initially, 25 mg of fluoxetine and 6 mg of olanzapine once daily in the evening as a fixed-combination capsule (Symbyax® 6/25).
This dosage generally should be used as initial and maintenance therapy in patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or those with factors that may slow metabolism of the drugs(s) (e.g., female gender, geriatric age, nonsmoking status); when indicated, dosage should be escalated with caution.
In other patients, increase dosages according to patient response and tolerance as indicated. 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. Dosages exceeding 18 mg of olanzapine and 75 mg of fluoxetine not evaluated in clinical studies.
Although the manufacturer states that long-term efficacy (>8 weeks) not established, patients have received the fixed combination ≤24 weeks in clinical trials. If used for >8 weeks, periodically reassess need for continued therapy.
Cataplexy
Oral
20 mg once or twice daily in conjunction with CNS stimulant therapy (e.g., dextroamphetamine, methylphenidate).†
Alcohol Dependence
Oral
60 mg daily has been used.†
Higher than average antidepressant SSRI dosage apparently is required for reduced alcohol intake; fluoxetine 40 mg daily is comparable to placebo in efficacy.†
Prescribing Limits
Adults
Oral
Conventional capsules, tablets, or solution: Maximum 80 mg daily.
Special Populations
Dosage in Hepatic Impairment
Reduce dose and/or frequency; some clinicians recommend a 50% reduction in initial dosage for patients with well-compensated cirrhosis.
Carefully individualize dosage in substantial hepatic impairment; adjust based on tolerance and therapeutic response.
Dosage in Renal Impairment
Consider reduction in dosage and/or frequency particularly in severe renal impairment. Supplemental doses after hemodialysis not necessary.
Geriatric Patients
Consider reducing dose and/or frequency.
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