CHLORPROMAZINE HYDROCHLORIDE- chlorpromazine hydrochloride tablet, sugar coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

CHLORPROMAZINE HYDROCHLORIDE

Composition:

CHLORPROMAZINE HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Chlorpromazine Hydrochloride Tablets, USP, 10 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "201" and no print on the reverse side. Chlorpromazine Hydrochloride Tablets, USP, 25 mg are available in blistercards of 30 (NDC 0615-7737-39). Chlorpromazine HCl Tablets, USP, 25 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "202" and no print on the reverse side. Chlorpromazine Hydrochloride Tablets, USP, 50 mg are available in blistercards of 30 (NDC 0615-7683-39). Chlorpromazine HCl Tablets, USP, 50 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "203" and no print on the reverse side. THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine Hydrochloride Tablets, USP, 100 mg are available in blistercards of 30 (NDC 0615-7717-39). Chlorpromazine Hydrochloride Tablets, USP 100 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "225" and no print on the reverse side. Chlorpromazine Hydrochloride Tablets, USP, 200 mg are round, butterscotch colored, sugar coated tablets, imprinted on one side with "SZ" above "249" and no print on the reverse side. Store at controlled room temperature 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. This package is not for household dispensing. Dispense in a well closed, light-resistant container as defined in the USP. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
SUGAR
COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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 sulf