CHLORPROMAZINE HYDROCHLORIDE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Northstar Rx LLC

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 tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "29" on other side. NDC 16714-047-01 in bottles of 100 tablets with child-resistance closure Chlorpromazine hydrochloride tablets, USP, 25 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "30" on other side. NDC 16714-048-01 in bottles of 100 tablets with child-resistance closure Chlorpromazine hydrochloride tablets, USP, 50 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "31" on other side. NDC 16714-049-01 in bottles of 100 tablets with child-resistance closure THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine hydrochloride tablets, USP, 100 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "32" on other side. NDC 16714-050-01 in bottles of 100 tablets with child-resistance closure Chlorpromazine hydrochloride tablets, USP, 200 mg tablet is brown colored, round, biconvex, film coated tablet debossed with "11" on one side and "33" on other side. NDC 16714-051-01 in bottles of 100 tablets with child-resistance closure Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Keep this and all drugs out of the reach of children. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Zydus Lifesciences Ltd., Baddi, India Rev.: 09/22

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
FILM COATED
NORTHSTAR RX LLC
----------
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, USP occurs as white to almost white
crystalline powder.
Each film coated tablet for oral administration contains 10 mg, 25 mg,
50 mg, 100 mg,
or 200 mg of chlorpromazine hydrochloride, USP.
or 200 mg of chlorpromazine hydrochloride, USP.
Inactive ingredients:
Calcium sulfate dihydrate, colloidal silicon dioxide, cr