Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
Chlorpromazine Hydrochloride (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P)
Sandoz, Inc.
ORAL
PRESCRIPTION DRUG
For the management of manifestations of psychotic disorders. 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 depr
Intended for institutional use. 30 mg/mL is available in 120 mL bottles and 100 mg/mL is available in 240 mL bottles. The concentrate form is light-sensitive. For this reason, it should be protected from light and dispensed in amber bottles. Refrigeration is not required. NDC 0781-4027-53: 30 mg/mL, 120 mL bottle NDC 0781-4028-22: 100 mg/mL, 240 mL bottle 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].
Abbreviated New Drug Application
CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE CONCENTRATE SANDOZ, INC. ---------- CHLORPROMAZINE HYDROCHLORIDE ORAL CONCENTRATE, 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 is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). DESCRIPTION Chlorpromazine is 10-(3-dimethylaminopropyl)-2-chlorphenothiazine, a dimethylamine derivative of phenothiazine. It is present in an oral concentrate as the hydrochloride salt. Concentrate - Each mL of clear, colorless to pale yellow solution contains chlorpromazine hydrochloride, 30 or 100 mg. Inactive ingredients consist of citric acid anhydrous, edetate disodium, sodium benzoate, sodium citrate dihydrate, sucralose, and purified water. CLINICAL PHARMACOLOGY The precise mechanism whereby the therapeutic effects of chlorpromazine hydrochloride are produced is not known. The principal pharmacological actions Прочитать полный документ