CHLORPROMAZINE HYDROCHLORIDE tablet, coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Lannett Company, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 nervo

Resumen del producto:

Chlorpromazine Hydrochloride Tablets, USP, 10 mg are brown-coated, round tablet, debossed with “61” on one side and “LCI” on the other side. NDC-0527-2961-37, bottles of 100 Chlorpromazine Hydrochloride Tablets, USP, 25 mg are brown-coated, round tablet, debossed with “62” on one side and “LCI” on the other side. NDC-0527-2962-37, bottles of 100 NDC-0527-2962-43, bottles of 1000 Chlorpromazine Hydrochloride Tablets, USP, 50 mg are brown-coated, round tablet, debossed with “LCI” and “63” on one side and plain on the other side. NDC-0527-2963-37, bottles of 100 NDC-0527-2963-43, bottles of 1000 THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine Hydrochloride Tablets, USP, 100 mg are brown-coated, round tablet, debossed with “LCI” and “64” on one side and plain on the other side. NDC-0527-2964-37, bottles of 100 NDC-0527-2964-43, bottles of 1000 Chlorpromazine Hydrochloride Tablets, USP, 200 mg are brown-coated, round tablet, debossed with “LCI” and “65” on one side and plain on the other side. NDC-0527-2965-37, bottles of 100 NDC-0527-2965-43, bottles of 1000 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 light and moisture. This package is not for household dispensing. If dispensed for outpatient use, a well closed, light-resistant, child-resistant container should be utilized. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET,
COATED
LANNETT COMPANY, INC.
----------
CHLORPROMAZINE HYDROCHLORIDE TABLETS, 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 hydrochloride, a dimethylamine derivative of
phenothiazine, has a chemical formula of
2-chloro-10-[3-(dimethylamino) propyl] phenothiazine
monohydrochloride. It is available in tablets for
oral administration. It has the following structural formula:
Chlorpromazine hydrochloride occurs as white or slightly creamy white,
odorless, crystalline powder
which darkens on prolonged exposure to light.
Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100
mg, or 200 mg of chlorpromazine
hydrochloride, USP.
Inactive ingredients: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Yellow
No. 6,