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. Compro® Prochlorperazine Suppositories USP is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Prochlorperazine is a clear, pale yellow, viscous liquid. It is sensitive to light, very slightly soluble in water, freely soluble in alcohol, in chloroform, and in ether.
Each suppository, for rectal administration, contains 25 mg of prochlorperazine; with glycerin, glyceryl monopalmitate, glyceryl monostearate, hydrogenated coconut oil fatty acids and hydrogenated palm kernel oil fatty acids.
Prochlorperazine 25mg suppositories are indicated in the control of severe nausea and vomiting in adults.
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Nausea and Vomiting
Source: MedicineNet Anaphylaxis Specialty [2016.02.22]
Title: Nausea and Vomiting
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 2/22/2016 12:00:00 AM
Published Studies Related to Compro (Prochlorperazine Rectal)
Indomethacin/prochlorperazine/caffeine: a review of its use in the acute treatment of migraine and in the treatment of episodic tension-type headache. [2011.04.01]
The indomethacin/prochlorperazine/caffeine fixed combination (Difmetre(R)) combines the NSAID indomethacin with the phenothiazine antiemetic prochlorperazine and caffeine. It is currently available as two oral (effervescent tablet and coated tablet) and two rectal (suppository and low-dose suppository) formulations...
Clinical Trials Related to Compro (Prochlorperazine Rectal)
Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine [Terminated]
The objective of this randomized, double blind study is to demonstrate that one dose oral
"excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to
one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in
the emergency department.
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine [Recruiting]
Opioids are commonly used to treat migraine in North American Emergency Departments. We are
comparing efficacy and adverse events of hydromorphone, an opioid, to that of
prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine
will be combined with diphenhydramine to prevent adverse events.
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department [Completed]
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl
OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure
is improvement in pain scales between the groups.
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department [Completed]
This study will compare the effect of prochlorperazine and ondansetron for the treatment of
nausea and vomiting in the emergency department.
Bioavailability of Prochlorperazine Suppositories, 25 mg [Completed]
The purpose of this study is to compare prochlorperazine plasma concentrations produced
after administration of the test formulation with those produced after administration of a
marketed reference product.
Page last updated: 2016-04-25