PROCHLORPERAZINE MALEATE
Prochlorperazine maleate is indicated for the control of severe nausea and vomiting and the treatment of schizophrenia. It is also approved for the short-term management of generalized non-psychotic anxiety; however, it is not considered first-line therapy because it carries risks, such as tardive dyskinesia, not associated with alternatives like benzodiazepines. When used for anxiety, prochlorperazine should not exceed a dosage of 20 mg per day or a duration of 12 weeks to mitigate the risk of irreversible tardive dyskinesia. It has not been shown effective for behavioral complications in patients with mental retardation or for anxiety associated with other non-psychotic conditions.
How PROCHLORPERAZINE MALEATE Works
Prochlorperazine is a piperazine phenothiazine derivative that primarily acts as a dopamine D2 receptor antagonist. Its antiemetic properties are derived from its ability to block dopamine receptors in the chemoreceptor trigger zone (CTZ) of the medulla. Its antipsychotic effects are attributed to the blockade of postsynaptic dopamine receptors in the mesolimbic and mesocortical pathways of the brain. Additionally, prochlorperazine exhibits alpha-adrenergic and anticholinergic blocking activity.
Details
- Status
- Prescription
- First Approved
- 1996-07-11
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PROCHLORPERAZINE MALEATE Approval History
What PROCHLORPERAZINE MALEATE Treats
4 indicationsPROCHLORPERAZINE MALEATE is approved for 4 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea
- Vomiting
- Schizophrenia
- Anxiety
PROCHLORPERAZINE MALEATE Boxed Warning
BOXED WARNING 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...
BOXED WARNING 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 ).
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROCHLORPERAZINE MALEATE FDA Label Details
ProIndications & Usage
FDA Label (PDF)INDICATIONS & USAGE 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...
BOXED WARNING 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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.