Prolixin

Indications
Dosage
How Supplied

INDICATIONS

PROLIXIN (fluphenazine) is indicated in the management of manifestations of psychotic disorders.

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

DOSAGE AND ADMINISTRATION

PROLIXIN (fluphenazine) Elixir should be inspected prior to use. Upon standing a slight wispy precipitate or globular material may develop due to the flavoring oils separating from the solution (potency is not affected). Gentle shaking redisperses the oils and the solution becomes clear. Solutions that do not clarify should not be used.

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 or orally administered PROLIXIN (fluphenazine hydrochloride) dosage forms, conversion to the long-acting injectable PROLIXIN (fluphenazine) 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.

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

HOW SUPPLIED

PROLIXIN® Tablets (Fluphenazine Hydrochloride Tablets USP)

5 mg: each film-coated tablet is green, round, biconvex, debossed with PPP over 877

bottles of 100 NDC 0003-0877-50

10 mg: each film-coated tablet is pink, round, biconvex, debossed with PPP over 956

bottles of 100 NDC 0003-0956-50

PROLIXIN® Elixir (Fluphenazine Hydrochloride Elixir USP)

0.5 mg/mL (2.5 mg per 5 mL teaspoonful)

60 mL bottle with calibrated dropper NDC 0003-0820-30

473 mL bottle NDC 0003-0820-50

PROLIXIN (Fluphenazine Hydrochloride) is also available as an oral solution concentrate and a sterile aqueous solution for intramuscular use. See specific package inserts for complete information.

Storage

Store tablets and elixir at room temperature. Protect from light. Keep tightly closed. Tablets: Avoid excessive heat. Elixir: Avoid freezing.

APOTHECON®, A Bristol-Myers Squibb Company Princeton, NJ 08540 USA.

Last reviewed on RxList: 4/22/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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