Prochlorperazine Edisylate 5 mg/mL
Prochlorperazine Edisylate · INJECTION · FOSUN PHARMA USA INC
Prochlorperazine Edisylate is a injection containing prochlorperazine edisylate at 5 mg/mL, taken intramuscular. Manufactured by FOSUN PHARMA USA INC.
Key Facts
- Brand Name
- Prochlorperazine Edisylate
- Generic Name
- Prochlorperazine Edisylate
- NDC Code (Product)
72266-204- Manufacturer
- FOSUN PHARMA USA INC
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA214107
- Marketing Start
- 05/01/2023
Recall History
Heritage Pharmaceuticals, Inc.
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE To control severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.
Dosage & Administration
DOSAGE AND 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. 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 lowest recommended dosage. IM Dosage Initially 5 mg to 10 mg (1 …
Warnings
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 Edisylate Injection, 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. Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic drug treatment, which patients are likely to develop the syndrome. Whether anti…
Contraindications
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.
Adverse Reactions
ADVERSE REACTIONS Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see WARNINGS ). 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. Neuromuscular (Extrapyramidal) Reactions These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower …
Frequently Asked Questions
What is Prochlorperazine Edisylate used for?
Prochlorperazine Edisylate contains Prochlorperazine Edisylate. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Prochlorperazine Edisylate a controlled substance?
Prochlorperazine Edisylate is not classified as a controlled substance by the DEA.
What is the generic name for Prochlorperazine Edisylate?
The generic name for Prochlorperazine Edisylate is Prochlorperazine Edisylate. There are 4 other brand versions of Prochlorperazine Edisylate.
What is the NDC code for Prochlorperazine Edisylate 5 mg/mL?
The NDC (National Drug Code) for Prochlorperazine Edisylate 5 mg/mL is 72266-204, listed by FOSUN PHARMA USA INC.