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Prolixin (Fluphenazine Decanoate) - Indications and Dosage



PROLIXIN is indicated in the management of manifestations of psychotic disorders.

PROLIXIN has not been shown effective in the management of behavioral complications in patients with mental retardation.


Depending on the severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 to 10.0 mg and should be divided and given at six- to eight-hour intervals.

The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses.

When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1.0 or 5.0 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements.

For psychotic patients who have been stabilized on a fixed daily dosage of orally administered PROLIXIN (fluphenazine hydrochloride) dosage forms, conversion to the long-acting injectable PROLIXIN Decanoate may be indicated [see package insert for PROLIXIN Decanoate (Fluphenazine Decanoate Injection) for conversion information].

For geriatric patients, the suggested starting dose is 1.0 to 2.5 mg daily, adjusted according to the response of the patient.

When the Oral Concentrate dosage form is to be used, the desired dose (measured by a calibrated device only) should be added to at least 60 mL (2 fl oz) of a suitable diluent just prior to administration to insure palatability and stability. Suggested diluents include tomato or fruit juice, milk, and uncaffeinated soft drinks. The Oral Concentrate should not be mixed with beverages containing caffeine (coffee, cola), tannics (tea), or pectinates (apple juice) because of potential incompatibility.

PROLIXIN Injection (Fluphenazine Hydrochloride Injection USP) is useful when psychotic patients are unable or unwilling to take oral therapy.


120 mL bottle with a 1 mL safety-cap dropper calibrated at 0.1 mL and in 0.2 mL increments. 5 mg fluphenazine hydrochloride per mL. NDC 0003-0801-10.

PROLIXIN (Fluphenazine Hydrochloride) is also available as a sterile aqueous solution for intramuscular use, plus tablets and elixir for oral administration. See specific package insert for complete information.


Store at room temperature; avoid freezing. Protect from light. Keep tightly closed.

Bristol-Myers Squibb Company
Princeton, NJ 08540


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