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:

Zameer Pharmaceuticals LLC

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 depressants (alcohol, barbiturates, narcotics, etc.).

Product summary:

Chlorpromazine Hydrochloride Tablets, USP, are round, light green colored, biconvex, sugar-coated tablets available in bottles of 100 in the following strengths: 10 mg: debossed with “10” on one side and “ω” on reverse side (NDC 90096-131-01) 25 mg: debossed with “25” on one side and “ω” on reverse side (NDC 90096-132-01) 50 mg: debossed with “50” on one side and “ω” on reverse side (NDC 90096-133-01) 100 mg*: debossed with “100” on one side and “ω” on reverse side (NDC 90096-134-01) 200 mg*:  debossed with “200” on one side and “ω” on reverse side (NDC 90096-135-01) *100 mg AND 200 mg TABLET STRENGTHS ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. 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. Rx only Product of India  Distributed by: Zameer Pharmaceuticals LLC. Iselin, NJ 08830 Rev. 10/2021 20768370 EM 15630

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
SUGAR COATED
ZAMEER PHARMACEUTICALS LLC
----------
CHLORPROMAZINE HYDROCHLORIDE TABLETS, USP
RX ONLY
BOXED 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 hydrochloride, USP.
Inactive ingredients: acacia, anhydrous lactose, calcium ca