PROCHLORPERAZINE MALEATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

RedPharm Drug, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Prochlorperazine maleate tablets are indicated for the control of severe nausea and vomiting. Prochlorperazine maleate tablets are also indicated for the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine maleate tablets are 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 maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets 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

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET
REDPHARM DRUG, INC.
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BOXED WARNING
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 Structural Formula]
C20H24ClN3S•2C4H4O4 M.W. 606.10
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 prochlo