PROCHLORPERAZINE MALEATE 10 mg/1
Prochlorperazine Maleate · TABLET · Bionpharma Inc.
Prochlorperazine maleate is a prescription medication taken by mouth that helps relieve nausea, vomiting, and severe dizziness. It can also be used to manage symptoms of certain psychiatric conditions.
Key Facts
- Brand Name
- PROCHLORPERAZINE MALEATE
- Generic Name
- Prochlorperazine Maleate
- NDC Code (Product)
69452-472- Manufacturer
- Bionpharma Inc.
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA217478
- Marketing Start
- 01/31/2025
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Jubilant Cadista Pharmaceuticals, Inc.
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Prochlorperazine has …
Dosage & Administration
(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. 1.To Control Severe Nausea and Vomiting: Adjust dosage to the response of the individual. Begin with the lowest recommended dosage. Oral Dosage-Tablets: Usually one 5mg or 10mg tablet 3 or 4 times daily. Daily dosages above 40 mgs should be used only in resistant cases. 2.In Adult Psychiatric Disorders: Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen. Oral Dosage: Non-Psychotic Anxiety--Usual dosage is 5 mg 3 or4 times daily. Do not administer in…
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 maleate 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 antipsychotic drug products …
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
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 maybe 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 dosage. Should these…
Frequently Asked Questions
What is PROCHLORPERAZINE MALEATE used for?
Prochlorperazine maleate is a prescription medication taken by mouth that helps relieve nausea, vomiting, and severe dizziness. It can also be used to manage symptoms of certain psychiatric conditions.
Is PROCHLORPERAZINE MALEATE a controlled substance?
PROCHLORPERAZINE MALEATE is not classified as a controlled substance by the DEA.
What is the generic name for PROCHLORPERAZINE MALEATE?
The generic name for PROCHLORPERAZINE MALEATE is Prochlorperazine Maleate. There are 6 other brand versions of Prochlorperazine Maleate.
What is the NDC code for PROCHLORPERAZINE MALEATE 10 mg/1?
The NDC (National Drug Code) for PROCHLORPERAZINE MALEATE 10 mg/1 is 69452-472, listed by Bionpharma Inc..