CHLORPROMAZINE HCI injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

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 HCI INJECTION, USP is supplied in the following dosage forms. NDC 51662-1406-1 CHLORPROMAZINE HCI INJECTION, USP 50 mg/2 mL (25 mg/mL) 2 mL AMPUL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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) 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), 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 West-Ward Pharmaceuticals 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. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised November 2016 462-637-02 PIN295-WES/3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORPROMAZINE HCI- CHLORPROMAZINE HCI INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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CHLORPROMAZINE HCI INJECTION, USP 50 MG/2 ML (25 MG/ML) 2 ML AMPUL
SPL UNCLASSIFIED
Rx only
BOXED WARNING
DESCRIPTION
Chlorpromazine HCl is chemically designated as
2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine
monohydrochloride and has the following structural formula:
C17H19ClN2S • 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 known.
The principal pharmacological actions are psychotropic. It also exerts
sedative and antiemetic activity.
Chlorpromazine has actions at all levels of the central nervous
system—primarily at subcortical levels
—as well as on multiple organ systems.
Chlorpromazine has strong antiadrenergic and weaker peripheral
anticholinergic activity; ganglionic
blocking action is relatively slight. It also possesses slight
antihistaminic and antiserotonin activity.
INDICATIONS & USAGE
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