FLUPHENAZINE HYDROCHLORIDE elixir

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

FLUPHENAZINE HYDROCHLORIDE (UNII: ZOU145W1XL) (Fluphenazine - UNII:S79426A41Z)

متاح من:

ATLANTIC BIOLOGICALS CORP.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Fluphenazine hydrochloride elixir is indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride 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, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross sensitivity to phenothiazine derivatives may occur.

ملخص المنتج:

Fluphenazine Hydrochloride Elixir USP 0.5 mg/mL (2.5 mg per 5 mL teaspoonful), available as an orange-colored, raspberry flavored elixir and is supplied in the following sizes: 60 mL bottle with calibrated dropper NDC 0121-0654-02 473 mL bottle NDC 0121-0654-16 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Avoid freezing. Dispense in tight, light-resistant containers only.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE ELIXIR
ATLANTIC BIOLOGICALS CORP.
----------
FLUPHENAZINE HYDROCHLORIDE
ELIXIR USP
RX ONLY
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
Hydrochloride Elixir USP is not approved for the treatment of patients
with dementia-related
psychosis (_see _WARNINGS).
DESCRIPTION
Fluphenazine hydrochloride is a trifluoromethyl phenothiazine
derivative intended for the management
of schizophrenia. Fluphenazine hydrochloride is described chemically
as 4-[3-[2-
(Trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazineethanol
dihydrochloride and its molecular
formula is C
H F N OS • 2HCl.
The structural formula is shown below:
MW = 510.44
Each mL of fluphenazine hydrochloride elixir for oral administration,
contains 0.5 mg fluphenazine
hydrochloride and alcohol 14% (v/v). Inactive ingredients: colorant
(FD&C Yellow No. 6), flavor,
glycerin, purified water, sodium benzoate, and sucrose. The