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:

Proficient Rx LP

INN (International Name):

PROCHLORPERAZINE MALEATE

Composition:

PROCHLORPERAZINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-psychotic conditions in w

Product summary:

Prochlorperazine maleate tablets USP are supplied as: 5 mg (as free base) tablets - yellow, round, film-coated; unscored on both sides, debossed “93” on one side and debossed “9643” on the other side, in bottles of 15 (NDC 63187-877-15), 30 (NDC 63187-877-30), 60 (NDC 63187-877-60) and 90 (NDC 63187-877-90). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. * 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. Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev. K 11/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET, FILM COATED
PROFICIENT RX LP
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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 and has the following structural formula:
C
H ClN S•2C H O M.W. 606.09
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 malea