CHLORPROMAZINE HYDROCHLORIDE concentrate

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Chlorpromazine Hydrochloride (UNII: 9WP59609J6) (Chlorpromazine - UNII:U42B7VYA4P)

Commercializzato da:

Azurity Pharmaceuticals, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

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 24338-403-12: 30 mg/mL, 120 mL bottle NDC 24338-410-24: 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE
HYDROCHLORIDE CONCENTRATE
AZURITY PHARMACEUTICALS, INC.
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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 pharmaco