מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CHLORPROMAZINE HYDROCHLORIDE (UNII: 9WP59609J6) (CHLORPROMAZINE - UNII:U42B7VYA4P)
Major Pharmaceuticals
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
Chlorpromazine Hydrochloride Tablets USP, 10 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B” with black ink on one side and plain on the other side. They are available as follows: Chlorpromazine Hydrochloride Tablets USP, 25 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B2” with black ink on one side and plain on the other side. They are available as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6893-61 Chlorpromazine Hydrochloride Tablets USP, 50 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B3” with black ink on one side and plain on the other side. They are available as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6894-61 THESE TABLET STRENGTHS LISTED BELOW ARE FOR USE ONLY IN SEVERE NEUROPSYCHIATRIC CONDITIONS. Chlorpromazine Hydrochloride Tablets USP, 100 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B4” with black ink on one side and plain on the other side. They are available as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6895-61 Chlorpromazine Hydrochloride Tablets USP, 200 mg are available as white colored, round shaped, biconvex film-coated tablets, imprinted “B5” with black ink on one side and plain on the other side. They are available as follows: Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6896-61 Store at 20° to 25°C (68° to 77°F); excursions permitted between 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 out of reach of children. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI 48152 USA Refer to package label for Distributor's NDC Number Rev. 12-2019-01
Abbreviated New Drug Application
CHLORPROMAZINE HYDROCHLORIDE- CHLORPROMAZINE HYDROCHLORIDE TABLET, FILM COATED MAJOR PHARMACEUTICALS ---------- CHLORPROMAZINE HYDROCHLORIDE TABLETS, USP (10 MG, 25 MG, 50 MG, 100 MG & 200 MG) 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, USP is a white to almost white crystalline powder. It is very soluble in water, freely soluble in ethanol (96%). Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: hypromellose, l קרא את המסמך השלם