CHLORPROMAZINE HYDROCHLORIDE injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Eugia US LLC

طريقة التعاطي:

INTRAMUSCULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.).

ملخص المنتج:

Chlorpromazine hydrochloride injection USP, 25 mg/ mL is a clear, slightly yellow colored solution essentially free from visible particles and is available in the following packages: 25 mg per mL 1 mL ampule                                                                                           NDC 55150-318-25 packaged in carton of 25 50 mg per 2 mL (25 mg / mL) 2 mL ampule                                                                                            NDC 55150-319-25 packaged in carton of 25 Storage 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) [see USP Controlled Room Temperature]. Protect from freezing. To report SUSPECTED ADVERSE REACTIONS, contact AuroMedics Pharma LLC at 1-866-850-2876, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: October 2021

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CHLORPROMAZINE HYDROCHLORIDE - CHLORPROMAZINE
HYDROCHLORIDE INJECTION
EUGIA US LLC
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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 is not approved for the
treatment of
patients with dementia-related psychosis (_see _WARNINGS).
DESCRIPTION
Chlorpromazine hydrochloride, USP is white or slightly creamy white,
crystalline powder
chemically designated as
2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine
monohydrochloride and has the following structural formula:
Chlorpromazine hydrochloride injection, USP is a clear, slightly
yellow colored solution
intended for deep intramuscular use. Each mL contains chlorpromazine
hydrochloride
USP 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 between 3.4 to 5.4.
CLINICAL PHARMACOLOGY
The precise mechanism whereby the the