FLUPHENAZINE DECANOATE injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Hikma Pharmaceuticals USA Inc.

ИНН (Международная Имя):

FLUPHENAZINE DECANOATE

состав:

FLUPHENAZINE DECANOATE 25 mg in 1 mL

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Fluphenazine Decanoate Injection, USP 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, USP 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 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.

Обзор продуктов:

Fluphenazine Decanoate Injection, USP, 25 mg/mL is available in 5 mL multiple dose vials, packaged in individual cartons. NDC 0143-9529-01. Protect from light.  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; avoid freezing and excessive heat. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

FLUPHENAZINE DECANOATE- FLUPHENAZINE DECANOATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
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 patient
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. Fluphenazine Decanoate Injection, USP is a sterile injection,
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. At the
time of manufacture, the air in the vials is replaced by nitrogen.
The chemical name of fluphenazine decanoate is
4-[3-[2-(Trifluoromethyl)-10_H_-
phenothiazin-10-yl]propyl]-1-piperazineethanol