PROCHLORPERAZINE MALEATE tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Preferred Pharmaceuticals, Inc.

INN (Nome Internazionale):

PROCHLORPERAZINE MALEATE

Composizione:

PROCHLORPERAZINE 10 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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PROCHLORPERAZINE MALEATE TABLETS, USP
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
equi