Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P)
Zydus Pharmaceuticals USA Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
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 year 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.).
Chlorpromazine hydrochloride injection, USP 25 mg/mL is available in the following packages: 1 mL single-dose vial packaged in 25s (NDC 70710-1849-7) 2 mL single-dose vial packaged in 25s (NDC 70710-1850-7) Storage Protect from light, or discoloration may occur. Slight yellowing will not alter potency. Discard if markedly discolored. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from freezing. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc., a t 1-877-993-8779 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.
Abbreviated New Drug Application
CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE INJECTION ZYDUS PHARMACEUTICALS USA INC. ---------- CHLORPROMAZINE HYDROCHLORIDE INJECTION, USP 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 times 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 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 g/mol Chlorpromazine hydrochloride injection, USP is a sterile aqueous clear colorless to yellow color 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 to 5.4. 17 19 2 CLINICAL PHARMACOLOGY The precise mechanism wher Прочитать полный документ