CHLORPROMAZINE HYDROCHLORIDE tablet sugar coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Chlorpromazine Hydrochloride (UNII: 9WP59609J6) (Chlorpromazine - UNII:U42B7VYA4P)

Disponible depuis:

Avera McKennan Hospital

DCI (Dénomination commune internationale):

Chlorpromazine Hydrochloride

Composition:

Chlorpromazine Hydrochloride 10 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
SUGAR
COATED
AVERA MCKENNAN HOSPITAL
----------
CHLORPROMAZINE HYDROCHLORIDE TABLETS, 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.
Chlorpromazine hydrochloride is not approved for the treatment of
patients with dementia-related
psychosis (see WARNINGS).
DESCRIPTION
Chlorpromazine hydrochloride, a dimethylamine derivative of
phenothiazine, has a chemical formula of
2-chloro-10-[3-(dimethylamino) propyl] phenothiazine
monohydrochloride. It is available in tablets for
oral administration. It has the following structural formula:
Chlorpromazine hydrochloride occurs as white or slightly creamy white,
odorless, crystalline powder
which darkens on prolonged exposure to light.
Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100
mg, or 200 mg of chlorpromazine
HCl, USP.
Inactive ingredients: acacia, black iron oxide, calcium sulfate,
carnauba wax,