PROCHLORPERAZINE EDISYLATE injection

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PROCHLORPERAZINE EDISYLATE (UNII: PG20W5VQZS) (PROCHLORPERAZINE - UNII:YHP6YLT61T)

Доступно од:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (Међународно име):

PROCHLORPERAZINE EDISYLATE

Састав:

PROCHLORPERAZINE 5 mg in 1 mL

Пут администрације:

INTRAMUSCULAR

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. 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.). Do not use in pediatric surgery. Do not use in pediatric patients under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.

Резиме производа:

Prochlorperazine Edisylate Injection, USP 5 mg/mL is a colorless to slightly yellowish solution. Prochlorperazine Edisylate Injection, USP is supplied as follows: Storage PROTECT FROM LIGHT . Store in the box until ready to use. Discard if markedly discolored. 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]. Manufactured by: Emcure Pharmaceuticals Ltd., Sanand, Ahmedabad - 382110, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUGS (3784) PREMIERPro Rx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Revised: 11/2020

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PROCHLORPERAZINE EDISYLATE- PROCHLORPERAZINE EDISYLATE INJECTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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RX ONLY
BOXED 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. Prochlorperazine Edisylate Injection, USP is not approved for
the treatment
of patients with dementia-related psychosis (see WARNINGS).
DESCRIPTION
Prochlorperazine edisylate,
2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine
1,2-ethanedisulfonate (1:1), has the following structural formula:
C
H
ClN S·C H O S MW 564.14
Prochlorperazine Edisylate Injection, an antiemetic and antipsychotic,
is a sterile solution
intended for intramuscular or intravenous administration.
Each mL contains prochlorperazine 5 mg as the edisylate, monobasic
sodium phosphate
monohydrate 5 mg, sodium tartrate dihydrate 12 mg, saccharin sodium
0.9 mg and
benzyl alcohol 7.5 mg in Water for Injection. pH 4.2-6.2.
CLINICAL PHARMACOLOGY
Prochlorperazine is a prop