Prochlorperazine edisylate injection
Other products: Prochlorperazine
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From MedlinePlus, U.S. National Library of Medicine
Boxed 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 Edisylate Injection, USP is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
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Preparation and administration
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DOSAGE & ADMINISTRATION NOTE ON INJECTION: For intramuscular administration, inject deeply into the upper, outer quadrant of the buttock. Subcutaneous administration is not advisable because of local irritation. Stability This solution should be protected from light. Slight yellowish discoloration will not alter potency.
If markedly discolored, solution should be discarded. Compatibility It is recommended that Prochlorperazine Edisylate Injection not be mixed with other agents in the syringe. Adults (For children's dosage and administration, see below.) 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.
Begin with lowest recommended dosage. IM Dosage Initially 5 mg to 10 mg (1 to 2 mL) injected deeply into the upper, outer quadrant of the buttock. If necessary, repeat every 3 or 4 hours. Total IM dosage should not exceed 40 mg per day. IV Dosage 2.5 mg to 10 mg (0.5 to 2 mL) by slow IV injection or infusion at a rate not to exceed 5 mg per minute.
Prochlorperazine Edisylate Injection may be administered either undiluted or diluted in isotonic solution. A single dose of the drug should not exceed 10 mg; total IV dosage should not exceed 40 mg per day. When administered IV, do not use bolus injection. Hypotension is a possibility if the drug is given by IV injection or infusion.
Subcutaneous administration is not advisable because of local irritation. ADULT SURGERY (FOR SEVERE NAUSEA AND VOMITING) Total parenteral dosage should not exceed 40 mg per day. Hypotension is a possibility if the drug is given by IV injection or infusion. IM Dosage 5 mg to 10 mg (1 to 2 mL) 1 to 2 hours before induction of anesthesia (repeat once in 30 minutes, if necessary), or to control acute symptoms during and after surgery (repeat once if necessary).
IV Dosage 5 mg to 10 mg (1 to 2 mL) as a slow IV injection or infusion 15 to 30 minutes before induction of anesthesia, or to control acute symptoms during or after surgery. Repeat once if necessary. Prochlorperazine may be administered either undiluted or diluted in isotonic solution, but a single dose of the drug should not exceed 10 mg.
Control is usually obtained with one dose. After control is achieved, switch the patient to an oral form of the drug at the same dosage level or higher. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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- Prochlorperazine edisylate injection
Contraindications
Do not use in patients with known hypersensitivity to phenothiazines. 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 pediatric patients under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
BLikelihood score B: Uncommon but likely cause of clinically apparent liver injury.
Prochlorperazine is a phenothiazine used primarily as an antiemetic agent. In rare instances, prochlorperazine can cause clinically apparent acute and chronic cholestatic liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Breastfeeding (LactMed)
Based on minimal excretion of other phenothiazine derivatives, it appears that occasional short-term use of prochlorperazine for the treatment of nausea and vomiting poses little risk to the breastfed infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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