PROCHLORPERAZINE MALEATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

PROCHLORPERAZINE MALEATE

Composition:

PROCHLORPERAZINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 out

Product summary:

Prochlorperazine Maleate Tablets, USP are available containing 5 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: NDC 43063-353-06 bottles of 6 tablets 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. *Levophed ® is a registered trademark of Abbott Laboratories. **Neo-Synephrine ® is a registered trademark of Abbott Laboratories. ***Dilantin ® is a registered trademark of Parke-Davis. †Amipaque ® is a registered trademark of Sanofi Pharmaceuticals. ‡Benadryl ® is a registered trademark of Parke-Davis. Revised: 11/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
REFERENCE LABEL SET ID: 27948FFA-7C8A-4B43-A5FB-59F868F36264
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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 prochlorpe