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:

Eugia US LLC

Designación común internacional (DCI):

FLUPHENAZINE DECANOATE

Composición:

FLUPHENAZINE DECANOATE 125 mg in 5 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 oc

Resumen del producto:

Fluphenazine Decanoate Injection, USP is a sterile, clear, pale yellow solution and is supplied as follows: 125 mg per 5 mL (25 mg/mL)    5 mL Multiple-Dose Vials    Packaged Individually                                                     NDC 55150-267-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light (keep in outer carton). The vial stoppers are 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. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: July 2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FLUPHENAZINE DECANOATE - FLUPHENAZINE DECANOATE INJECTION, SOLUTION
EUGIA US 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 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 USP is a yellow solid.
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 USP (equivalent to 18.5 mg fluphenazine) per mL in a sesame
oil vehicle with
12 mg benzyl alcohol as a preservative.
CLINICAL PHARMACOLOGY
The basic effects of fluphenazine decan