CHLORPROMAZINE- chlorpromazine hydrochloride tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

chlorpromazine hydrochloride (UNII: 9WP59609J6) (chlorpromazine - UNII:U42B7VYA4P)

Disponible des:

Mayne Pharma Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 system depr

Resumen del producto:

Chlorpromazine Hydrochloride Tablets, USP, 10 mg are available in bottles of 100 (NDC 51862-590-01). Chlorpromazine HCl Tablets, USP, 10 mg are round biconvex blue coated tablet with "590" on one side and "m" on the other. Chlorpromazine Hydrochloride Tablets, USP, 25 mg are available in bottles of 100 (NDC 51862-592-01). Chlorpromazine HCl Tablets, USP, 25 mg are round biconvex blue coated tablet with "592" on one side and "m" on the other. Chlorpromazine Hydrochloride Tablets, USP, 50 mg are available in bottles of 100 (NDC 51862-594-01). Chlorpromazine HCl Tablets, USP, 50 mg are round biconvex orange coated tablet with "594" on one side and "m" on the other. THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine Hydrochloride Tablets, USP, 100 mg are available in bottles of 100 (NDC 51862-596-01). Chlorpromazine HCl Tablets, USP, 100 mg are round biconvex purple coated tablet with "596" on one side and "m" on the other. Chlorpromazine Hydrochloride Tablets, USP, 200 mg are available in bottles of 100 (NDC 51862-598-01). Chlorpromazine HCl Tablets, USP, 200 mg are round biconvex purple coated tablet with "598" on one side and "m" on the other. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from light and moisture. This package is not for household dispensing. If dispensed for outpatient use, a well closed, light-resistant, child-resistant container should be utilized. Keep out of reach of children.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CHLORPROMAZINE- CHLORPROMAZINE HYDROCHLORIDE TABLET
MAYNE PHARMA INC.
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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: lactose monohydrate, microcrystalline cellulose,
croscarmellose
sodium, povidone, colloidal