FLUPHENAZINE DECANOATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUPHENAZINE DECANOATE (UNII: FMU62K1L3C) (FLUPHENAZINE - UNII:S79426A41Z)

Available from:

Par Pharmaceutical, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation. Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics. Fluphenazine Decanoate Injection is contraindicated in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate. Fluphenazine Decanoate Injection is not intended for use in children under 12 years of age. Fluphenazine Decanoate Injection is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.

Product summary:

Fluphenazine Decanoate Injection, USP NDC 42023-129-89: 25 mg/mL in 5 mL multiple dose, flip-top vial individually packaged. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Retain vial in carton until ready for use. Vial stoppers do not contain natural rubber latex. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUPHENAZINE DECANOATE- FLUPHENAZINE DECANOATE INJECTION, SOLUTION
PAR PHARMACEUTICAL, INC.
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FLUPHENAZINE DECANOATE INJECTION, USP
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS -
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an
increased risk of death. Analyses of seventeen placebo-controlled
trials (modal duration of 10
weeks), largely in patients taking atypical antipsychotic drugs,
revealed a risk of death in drug
treated patients of between 1.6 to 1.7 times the risk of death in
placebo-treated patients. Over the
course of a typical 10-week controlled trial, the rate of death in
drug-treated patients was about
4.5%, compared to a rate of about 2.6% in the placebo group. Although
the causes of death were
varied, most of the deaths appeared to be either cardiovascular (e.g.,
heart failure, sudden death)
or infectious (e.g., pneumonia) in nature. Observational studies
suggest that, similar to atypical
antipsychotic drugs, treatment with conventional antipsychotic drugs
may increase mortality. The
extent to which the findings of increased mortality in observational
studies may be attributed to the
antipsychotic drug as opposed to some characteristic(s) of the
patients is not clear. Fluphenazine
decanoate injection is not approved for the treatment of patients with
dementia-related psychosis
_(see _WARNINGS).
DESCRIPTION
Fluphenazine decanoate is the decanoate ester of a trifluoromethyl
phenothiazine derivative. It is a
highly potent behavior modifier with a markedly extended duration of
effect and has the following
structural formula:
IMAG E- 1
Fluphenazine Decanoate Injection, USP is available as a clear, pale
yellow solution for intramuscular
(IM) or subcutaneous (SC) use providing 25 mg fluphenazine decanoate
per mL in a sesame oil vehicle
with 12 mg benzyl alcohol as a preservative.
CLINICAL PHARMACOLOGY
The basic effects of fluphenazine decanoate appear to be no different
from those of fluphenazine
hydrochloride, with the e