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:

TYA Pharmaceuticals

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:

NDC:64725-1397-1 in a CARTON of 25 INJECTIONS Protect from light, or discoloration may occur. Slight yellowing will not alter potency. Discard if markedly discolored. Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from freezing. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. 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. HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Manufactured by: Distributed by: PHARMACEUTICALS Eatontown, NJ 07724 USA WEST-WARD Revised January 2012 462-637-00 PIN295-WES/1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE INJECTION
TYA PHARMACEUTICALS
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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.
CLINICAL PHARMACOLOGY
The precise mechanism whereby the therapeutic effects of
chlorpromazine are produced is not k