Fluphenazine

What it is used for

Fluphenazine Hydrochloride Injection, USP is indicated in the management of manifestations of psychotic disorders.

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

How to take it

The average well tolerated starting dose for adult psychotic patients is 1.25 mg (0.5 mL) intramuscularly. Depending on the severity and duration of symptoms, initial total daily dosage may range from 2.5 to 10 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 parenteral dose for fluphenazine has been found to be approximately 1/3 to 1/2 the oral dose. Treatment may be instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Dosages exceeding 10 mg daily should be used with caution.

When symptoms are controlled, oral maintenance therapy can generally be instituted often with single daily doses. Continued treatment by the oral route, if possible, 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Who should not take it

Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

If you are pregnant or breastfeeding

Non-teratogenic Effects

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Fluphenazine Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Leukopenia, Neutropenia and Agranulocytosis

In clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.

Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Fluphenazine Hydrochloride Injection, USP at the first sign of a decline in WBC in the absence of other causative factors.

Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000 mm 3 ) should discontinue Fluphenazine Hydrochloride Injection, USP and have their WBC followed until recovery.