PROCHLORPERAZINE MALEATE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

PROCHLORPERAZINE MALEATE (UNII: I1T8O1JTL6) (PROCHLORPERAZINE - UNII:YHP6YLT61T)

Доступно од:

PD-Rx Pharmaceuticals, Inc.

INN (Међународно име):

PROCHLORPERAZINE MALEATE

Састав:

PROCHLORPERAZINE 10 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). 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 Maleate Tablets, USP are available in the following strengths and package sizes: 10mg Chartreuse, round, film-coated tablet debossed with "TL" on the top and "115" on the bottom of the score line on one side and plain on the other side. Bottles of 6     NDC 43063-742-06 Bottles of 15    NDC 43063-742-15

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
PROCHLORPERAZINE MALEATE 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. Prochlorperazine maleate is not approved for the treatment of
patients with
dementia-related psychosis (see WARNINGS).
DESCRIPTION
Prochlorperazine, USP is a phenothiazine derivative, present in
prochlorperazine tablets
as the maleate. Prochlorperazine maleate is designated chemically as
2-chloro-10-[3-(4-
methyl-1 -piperazinyl)propyl] phenothiazine maleate [molecular weight
606.10] and has
the following structure
Prochlorperazine Maleate is classified as an anti-emetic and
antipsychotic agent.
Prochlorperazine maleate is white or pale yellow, practically odorless
crystalline powder.
It is practically insoluble in water and in alcohol; slightly soluble
in warm chloroform.
Each tablet, for oral administration contains prochlorperazine maleate
equivalent