Prochlorperazine Labeling: Indicated for Severe Nausea/Vomiting and Schizophrenia
This entry reflects the Indications and Usage section of prochlorperazine's FDA labeling. Two uses are identified: control of severe nausea and vomiting, and treatment of schizophrenia. The label also includes a specific negative statement clarifying that prochlorperazine has not been shown effective in managing behavioral complications in patients with mental retardation.
No study design, sample size, patient population details, comparators, efficacy endpoints, or statistical results are reported in the abstract. Likewise, the abstract does not describe route of administration, dose, formulation (oral vs parenteral), pediatric weight or age cutoffs, or any approval date or application number. Clinicians needing those specifics should consult the full prescribing information rather than inferring them from this excerpt.
Safety, adverse event profile, contraindications, warnings, and drug interactions are not addressed in the abstract and should not be assumed. Well-known class-level concerns associated with phenothiazines are not referenced here and therefore cannot be attributed to this labeling text.
Limitations of this summary are substantial: the source material is a brief indications statement, not a clinical trial report. It supports only the general fact of labeled indications and the explicit exclusion for behavioral complications in mental retardation. Any more granular claim about efficacy, tolerability, or use setting is outside the scope of what is reported.
For practice, the takeaway is limited to recognizing the two labeled indications and the specific negative indication noted in the label. Prescribing decisions should rely on the complete prescribing information and current clinical guidance, not on this abstract alone.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Prochlorperazine Edisylate Injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia. It has not been shown effective in managing behavioral complications in patients with mental retardation. For severe nausea and vomiting, it is used in adults and children over 20 pounds or two years of age. For schizophrenia, it is used in adults and children under 12 years of age, with dosage based on body weight. Elderly patients and those who are debilitated or emaciated require lower dosages and close monitoring due to increased susceptibility to adverse effects.
For severe nausea and vomiting in adults: IM dosage is initially 5 mg to 10 mg, repeated every 3 or 4 hours as needed, not exceeding 40 mg per day. IV dosage is 2.5 mg to 10 mg by slow injection or infusion at a rate not exceeding 5 mg per minute, not exceeding 40 mg per day. For adult surgery: IM dosage is 5 mg to 10 mg 1 to 2 hours before anesthesia or during/post-surgery, repeated once if necessary. IV dosage is 5 mg to 10 mg 15 to 30 minutes before anesthesia or during/post-surgery, repeated once if necessary. For psychiatric disorders in adults: IM dosage is initially 10 mg to 20 mg, repeated every 2 to 4 hours to gain control, then switch to oral form. For children with severe nausea and vomiting or schizophrenia: IM dosage is calculated as 0.06 mg per lb of body weight, administered deeply into the buttock. Do not use in pediatric surgery. Administer intramuscularly into the upper, outer quadrant of the buttock; subcutaneous administration is not advisable. Protect from light; discard if markedly discolored. Do not mix with other agents in the syringe.
Trial data not available in label.
Warnings include increased mortality in elderly patients with dementia-related psychosis, but the label text is incomplete. Precautions: Elderly patients are more susceptible to hypotension and neuromuscular reactions; use lower dosages and monitor closely. Children are more prone to extrapyramidal reactions; use lowest effective dosage and avoid in acute illnesses or dehydration. Do not exceed prescribed dosage in children. Hypotension is possible with IV administration; avoid bolus injection. Subcutaneous administration is not advisable due to local irritation. Not for use in conditions where pediatric dosages are not established.
Not reported in label.
More on Schizophrenia
View Original Abstract ↓
PETRUSHKA decision-support tool reduced treatment discontinuation and improved symptoms in major depressive disorder
The Algorithm That Helps Doctors Pick the Right Antidepressant for You
Related in Psychiatry
From Other Specialties
