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:

Gland Pharma Limited

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 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°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.   Manufactured by: Gland Pharma Limited Hyderabad - 502307, INDIA Issued: May 2021

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FLUPHENAZINE DECANOATE - FLUPHENAZINE DECANOATE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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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 sterile,
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, wi