CHLORPROMAZINE HYDROCHLORIDE- chlorpromazine tablet, sugar coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Sun Pharmaceutical Industries Inc

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance. Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous

Sommarju tal-prodott:

Chlorpromazine hydrochloride tablets, USP, 10 mg are round shaped, red colored, biconvex, sugar coated tablets, imprinted with ‘509 ’ on one side and no print on reverse side. Chlorpromazine hydrochloride tablets, USP, 25 mg are round shaped, light yellow colored, biconvex, sugar coated tablets, imprinted with ‘510 ’ on one side and no print on reverse side. Chlorpromazine hydrochloride tablets, USP, 50 mg are round shaped, white colored, biconvex, sugar coated tablets, imprinted with ‘511 ’ on one side and no print on reverse side. THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine hydrochloride tablets, USP, 100 mg are round shaped, white colored, biconvex, sugar coated tablets, imprinted with ‘512 ’ on one side and no print on reverse side. Chlorpromazine hydrochloride tablets, USP, 200 mg are round shaped, white colored, biconvex, sugar coated tablets, imprinted with ‘513 ’ on one side and no print on reverse side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. These containers are not for household use. If dispensed for outpatient use, a well closed, light-resistant, child-resistant containers should be utilized. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information, call Sun Pharmaceutical Industries Inc. at 1-800-818-4555. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 MADE IN INDIA

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE TABLET, SUGAR COATED
SUN PHARMACEUTICAL INDUSTRIES INC
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CHLORPROMAZINE HYDROCHLORIDE TABLETS, USP
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, USP, 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:
C
H
ClN S. HCl
M.W. 355.33 g/mol
Chlorpromazine hydrochloride occurs as white or slightly creamy white,
crystalline
17
19
2
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 hydrochloride, USP.
Inactive ingredients: calcium sulfate dihydrat