Prochlorperazine
Generic Name: prochlorperazine
Brand Names:
Prochlorperazine
DESCRIPTION Prochlorperazine Suppositories, USP, a phenothiazine derivative is designated chemically as 2-Chloro-10-[3-(4-,methyl-1-piperazinyl)propyl] phenothiazine with the following structural formula: Each suppository contains 25 mg prochlorperazine and the following inactive ingredients: glycerin, glyceryl monostearate, hydrogenated coconut oil fatty acids, hydrogenated palm kernel oil fatty acids. Prochlorperazine
Overview
DESCRIPTION Prochlorperazine Suppositories, USP, a phenothiazine derivative is designated chemically as 2-Chloro-10-[3-(4-,methyl-1-piperazinyl)propyl] phenothiazine with the following structural formula: Each suppository contains 25 mg prochlorperazine and the following inactive ingredients: glycerin, glyceryl monostearate, hydrogenated coconut oil fatty acids, hydrogenated palm kernel oil fatty acids. Prochlorperazine
Uses
INDICATIONS AND USAGE Prochlorperazine Suppositories, USP 25 mg are indicated in the control of severe nausea and vomiting in adults.
Dosage
DOSAGE AND ADMINISTRATION Adults: Dosage should be increased more gradually in debilitated or emaciated patients. Elderly Patients: In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients. To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage. Rectal Dosage: 25 mg twice daily.
Side Effects
ADVERSE REACTIONS Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy.
Warnings
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. WARNINGS 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. Prochlorperazine Suppositories, USP is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's Syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's Syndrome. CONTRAINDICATIONS Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). Do not use in pediatric surgery. Do not use in children under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.
Storage
HOW SUPPLIED For Adults, Prochlorperazine Suppositories, USP 25 mg in boxes of 12 and 1000 as follows: Box of 12 NDC 0713-0135-12 Box of 1000 NDC 0713-0135-10 Rx only Storage: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not remove from foil until ready to use. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0135CPLNC2 Rev. 01/2025 VC7778
Frequently Asked Questions
What is Prochlorperazine used for?▼
INDICATIONS AND USAGE Prochlorperazine Suppositories, USP 25 mg are indicated in the control of severe nausea and vomiting in adults.
What are the side effects of Prochlorperazine?▼
ADVERSE REACTIONS Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established. Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy.
What are the important warnings for Prochlorperazine?▼
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. WARNINGS 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. Prochlorperazine Suppositories, USP is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye's Syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's Syndrome. CONTRAINDICATIONS Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). Do not use in pediatric surgery. Do not use in children under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.