FLUPHENAZINE HYDROCHLORIDE solution, concentrate

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Pharmaceutical Associates, Inc.

INN (International Name):

FLUPHENAZINE HYDROCHLORIDE

Sammensætning:

FLUPHENAZINE HYDROCHLORIDE 5 mg in 1 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluphenazine hydrochloride 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.

Produkt oversigt:

Fluphenazine Hydrochloride Oral Solution USP (Concentrate), a colorless, unflavored concentrated liquid is available in the following oral dosage form: NDC 0121-0653-04: 4 fl oz (120 mL) bottle with a 1 mL safety-cap dropper calibrated at 0.1 mL and in 0.2 mL increments. 5 mg fluphenazine hydrochloride per mL. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Avoid freezing. Protect from light. Keep tightly closed.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE SOLUTION,
CONCENTRATE
PHARMACEUTICAL ASSOCIATES, INC.
----------
FLUPHENAZINE HYDROCHLORIDE ORAL
SOLUTION USP (CONCENTRATE)
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 Oral Solution USP (Concentrate) 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. Each mL of Fluphenazine Hydrochloride
Oral Solution
USP (Concentrate), for oral administration, contains fluphenazine
hydrochloride, 5 mg;
alcohol, 14%. In addition, each mL contains the following inactive
ingredients: glycerin,
purified water, and sodium benzoate. Fluphenazine hydrochloride has
the following
structure:
4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazineethanol
dihydrochloride
CLINICAL PHARMACOLOGY
Fluphe