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Dosing Considerations: pms-FLUOXETINE (fluoxetine hydrochloride) is not indicated for use in children under 18 year of age (see General: Potential Association with Behavioural and Emotional Changes, Including Self-Harm under Precautions).
General: During maintenance therapy, the dosage should be kept at the lowest effective level.
Dose Adjustment: Since it may take up to four or five weeks to reach steady-state plasma levels of fluoxetine, sufficient time should be allowed to elapse before dosage is gradually increased. Higher dosages are usually associated with an increased incidence of adverse reactions.
Switching Patients to a Tricyclic Antidepressant (TCA): Dosage of a TCA may need to be reduced and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued (see Drug-Drug Interactions: Tricyclic Antidepressants under Interactions).
Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI): At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with pms-FLUOXETINE. In addition, at least 5 weeks, perhaps longer, should be allowed after stopping pms-FLUOXETINE before starting MAOI (see Monoamine Oxidase Inhibitors under Contraindications).
Discontinuation of Treatment: When dosing is stopped, active drug substances will persist in the body for weeks. This should be borne in mind when starting or stopping treatment. Dosage tapering is unnecessary in most patients.
Despite its long-half life, symptoms associated with the discontinuation of fluoxetine have been reported in clinical trials and post-marketing. Patients should be monitored for these and other symptoms when discontinuing treatment, regardless of the indication for which pms-FLUOXETINE is being prescribed. Fluoxetine has been only rarely associated with such symptoms. Plasma fluoxetine and norfluoxetine concentrations decrease gradually at the conclusion of therapy, which makes dose tapering unnecessary in most patients (See General: Potential Association with Behavioural and Emotional Changes, Including Self-Harm: Discontinuation Symptoms under Precautions; Adverse Events Leading to Discontinuation of Treatment: Adverse Events Subsequent to Discontinuation under Adverse Reactions).
Adults: Depression: Initial Adult Dosage: The usual initial dosage is 20 mg administered once daily in the morning. A gradual dose increase should be considered only after a trial period of several weeks if the expected clinical improvement does not occur. Dosage should not exceed a maximum of 60 mg per day.
Long Term: The efficacy of fluoxetine in maintaining an antidepressant response for up to 38 weeks following 12 weeks of open-label acute treatment (50 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving pms-FLUOXETINE for extended periods should be re-evaluated periodically (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Bulimia Nervosa: Adult Dosage: The recommended dosage is 60 mg per day, although studies show that lower doses may also be efficacious. Electrolyte levels should be assessed prior to initiation of treatment.
Obsessive-Compulsive Disorder: A dose range of 20 mg/day to 60 mg/day is recommended for the treatment of obsessive-compulsive disorder.
Special Patient Populations: For any indication: Use in Pregnant Women: Results of a number of epidemiological studies of pregnancy outcomes following early maternal exposure to antidepressants have been inconsistent, but there is some evidence of a possible small increase in the risk of cardiac malformations (e.g. ventricular and septal defects) associated with use of fluoxetine. The mechanism is unknown. The use of pms-FLUOXETINE during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus taking into account the risks associated with untreated depression.
Post-marketing reports indicate that some neonates exposed to fluoxetine, SSRIs or other newer anti-depressants, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see Pregnant Women: Effects on Newborns and Complications following late third trimester exposure to SSRIs under Use in Pregnancy & Lactation). When treating pregnant women with pms-FLUOXETINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering pms-FLUOXETINE in the third trimester.
Use in the Elderly: Fluoxetine was evaluated in depressed elderly patients only at a dosage of 20 mg/day. A lower or less frequent dosage may be effective and should be considered in elderly patients with concurrent disease or on multiple medications.
Use in Children: pms-FLUOXETINE is not indicated for use in children under 18 year of age (see General: Potential Association with Behavioural and Emotional Changes, Including Self-Harm under Precautions).
Debilitated Patients: A lower or less frequent dosage should be used in patients with renal and/or hepatic impairment and in those on multiple medications.
