FLUPHENAZINE DECANOATE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Mylan Institutional LLC

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in themanagement of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronicschizophrenics). Fluphenazine Decanoate Injection has not been shown effective in the management of behavioralcomplications 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.

Dettagli prodotto:

Fluphenazine Decanoate Injection, USP 25 mg/mL is available as follows: 5 mL Multiple Dose Vial……..NDC 67457-359-59 At the time of manufacture, the air in the vials is replaced by nitrogen. Each vial is individually cartoned. Storage Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Avoid freezing and excessive heat. PROTECT FROM LIGHT. *The Initiation of Long-Term Pharmacotherapy in Schizophrenia: Dosage and Side Effect Comparisons Between Oral and Depot Fluphenazine; N.R. Schooler; Pharmakopsych. 9:159-169, 1976. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India JUNE 2022

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUPHENAZINE DECANOATE- FLUPHENAZINE DECANOATE INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
----------
FLUPHENAZINE DECANOATE INJECTION, USP 25 MG/ML
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 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. Fluphenazine Decanoate is
2-4-[3-(2-trifluoromethylphenothiazin-10-yl)-
propyl]-piperazin-1 -yl]ethyl decanoate. It is a highly potent
behavior modifier with a
markedly extended duration of effect. Fluphenazine Decanoate Injection
is a sterile
solution available for intramuscular or subcutaneous administration,
providing 25 mg
fluphenazine decanoate per mL in a sesame oil vehicle with 1.2% (w/v)
benzyl alcohol as
a preservative. Fluphenazine decanoate has the following structural
formula:
CLINICAL PHARMACOLOGY