CHLORPROMAZINE HYDROCHLORIDE tablet, sugar coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P)

MAH:

Mylan Institutional Inc.

INN:

CHLORPROMAZINE HYDROCHLORIDE

composition:

CHLORPROMAZINE HYDROCHLORIDE 10 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessiv

leaflet_short:

Chlorpromazine Hydrochloride Tablets, USP, 10 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "832" above "10" and no print on the reverse side. They are available as follows: NDC 51079-518-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Chlorpromazine Hydrochloride Tablets, USP, 25 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "832" above "25" and no print on the reverse side. They are available as follows: NDC 51079-519-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Chlorpromazine Hydrochloride Tablets, USP, 50 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "832" above "50" and no print on the reverse side. They are available as follows: NDC 51079-130-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine Hydrochloride Tablets, USP, 100 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "832" above "100" and no print on the reverse side. They are available as follows: NDC 51079-516-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Chlorpromazine Hydrochloride Tablets, USP, 200 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "832" above "200" and no print on the reverse side. They are available as follows: NDC 51079-517-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

authorization_status:

Abbreviated New Drug Application

SPC

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
SUGAR
COATED
MYLAN INSTITUTIONAL INC.
----------
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,