PROCHLORPERAZINE MALEATE tablet PROCHLORPERAZINE MALEATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aidarex Pharmaceuticals LLC

INN (International Name):

PROCHLORPERAZINE MALEATE

Sammensetning:

PROCHLORPERAZINE 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 5mg (Chartreuse, round, scored, film-coated, imprinted TL 113) Bottles of 6             NDC 33261-0141-06 Bottles of 20           NDC 33261-0141-20 10mg (Chartreuse, round, scored, film-coated, imprinted TL 115) Bottles of 6             NDC 33261-0550-06 Bottles of 30           NDC 33261-0550-30

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET
AIDAREX PHARMACEUTICALS LLC
----------
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 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