CHLORPROMAZINE HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

CHLORPROMAZINE HYDROCHLORIDE

Composition:

CHLORPROMAZINE HYDROCHLORIDE 25 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Injection, USP 25 mg/ mL is available in the following packages: 1 mL ampul packaged in 25s (NDC 0641-1397-35) 2 mL ampul packaged in 25s (NDC 0641-1398-35) Protect from light, or discoloration may occur. Slight yellowing will not alter potency. Discard if markedly discolored. 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 freezing. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised March 2020 462-637-04 PIN295-WES/5

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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CHLORPROMAZINE HYDROCHLORIDE INJECTION, 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 Injection, USP is not approved for
the
treatment of patients with dementia-related psychosis (_see
_WARNINGS).
DESCRIPTION
Chlorpromazine HCl is chemically designated as
2-Chloro-10-[3-(dimethylamino)propyl]-
phenothiazine monohydrochloride and has the following structural
formula:
C
H
ClN S • HCl MW 355.33
Chlorpromazine Hydrochloride Injection, USP is a sterile aqueous
solution intended for
deep intramuscular use. Each mL contains chlorpromazine hydrochloride
25 mg,
ascorbic acid 2 mg, sodium metabisulfite 1 mg, sodium sulfite 1 mg and
sodium chloride
6 mg in Water for Injection. pH is 3.4-5.4.
17
19
2
CLINICAL PHARMACOLOGY
The precise mechanism whereby the therapeutic effects of
chlorpromazine are