PROCHLORPERAZINE MALEATE- prochlorperazine maleate tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bryant Ranch Prepack

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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-psychoti

Dettagli prodotto:

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. Product: 71335-0952 NDC: 71335-0952-1 10 TABLET in a BOTTLE NDC: 71335-0952-2 30 TABLET in a BOTTLE NDC: 71335-0952-3 20 TABLET in a BOTTLE NDC: 71335-0952-4 60 TABLET in a BOTTLE NDC: 71335-0952-5 4 TABLET in a BOTTLE NDC: 71335-0952-6 5 TABLET in a BOTTLE NDC: 71335-0952-7 100 TABLET in a BOTTLE NDC: 71335-0952-8 6 TABLET in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROCHLORPERAZINE MALEATE - PROCHLORPERAZINE MALEATE TABLET
BRYANT RANCH PREPACK
----------
PROCHLORPERAZINE MALEATE TABLETS, USP
RX ONLY
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSISElderly 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 to 5 m