PROCHLORPERAZINE MALEATE- prochlorperazine maleate tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

PROCHLORPERAZINE MALEATE

Sammensetning:

PROCHLORPERAZINE 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Prochlorperazine Maleate Tablets, USP are available containing 5 mg or 10 mg of prochlorperazine as prochlorperazine maleate, USP. The 5 mg tablets are maroon film-coated, round, unscored tablets debossed with P1 on one side and M on the other side. They are available as follows: The 10 mg tablets are maroon film-coated, round, unscored tablets debossed with P2 on one side and M on the other side. They are available as follows: NDC: 35356-672-05 Bottles of 5 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED SEPTEMBER 2010 PCPZ:R12

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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:
C
H
CLN S•2C H O M.W. 606.10
C
H
CLN S•2C H O 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