FLUPHENAZINE DECANOATE- fluphenazine decanoate injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Fresenius Kabi USA, LLC

Designación común internacional (DCI):

FLUPHENAZINE DECANOATE

Composición:

FLUPHENAZINE DECANOATE 25 mg in 1 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light (keep in outer carton). The container closure is not made with natural rubber latex. * Schooler, N.R.: The Initiation of Long-Term Pharmacotherapy in Schizophrenia: Dosage and Side Effect Comparisons between Oral and Depot Fluphenazine Pharmakopsych. 9:159-169, 1976.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FLUPHENAZINE DECANOATE - FLUPHENAZINE DECANOATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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FLUPHENAZINE DECANOATE INJECTION, USP
Rx only
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, USP 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:
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