Uses
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Psychotic Disorders
Symptomatic management of psychotic disorders (i.e., schizophrenia).
Nonpsychotic Anxiety
Short-term management of nonpsychotic anxiety in patients with generalized anxiety disorder.
Not established whether prochlorperazine is useful for the management of other nonpsychotic conditions in which anxiety or manifestations that mimic anxiety are evident (e.g., physical illness, organic mental conditions, agitated depression, character pathologies).
Because of the risks of toxicity, use only as an alternative to other less toxic anxiolytic agents (e.g., benzodiazepines) in most patients.
Nausea and Vomiting
Management of severe nausea and vomiting of various etiologies (e.g., postoperative, acute migraine, toxins, radiation, or cytotoxic drugs).
Not effective in preventing vertigo or motion sickness, or for the management of emesis caused by the action of drugs on the nodose ganglion or locally on the GI tract.
Use not recommended for the prevention and treatment of nausea and vomiting associated with pregnancy except in cases of severe nausea and vomiting so serious and intractable that pharmacologic intervention is required and the potential benefits justify the possible risks to the fetus. (See Fetal/Neonatal Morbidity under Cautions.)
Other Uses
Has not been shown to be effective for the management of behavioral complications in patients with mental retardation.
Dosage and Administration
General
- Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.
- Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued. (See Tardive Dyskinesia under Cautions.)
Psychotic Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
- Symptomatic relief of psychotic disorders may be seen in many patients during the first 2 days of therapy; however, optimum antipsychotic effect usually requires prolonged administration of the drug.
- For prompt control of severe psychotic symptoms, administer IM; after symptoms are controlled, oral therapy should replace parenteral therapy at the same dosage level or higher.
Administration
Prochlorperazine edisylate is administered orally, by deep IM injection, by direct IV injection, or by IV infusion.
Prochlorperazine maleate is administered orally.
Prochlorperazine is administered rectally.
Sub-Q administration is not recommended because of local irritation.
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
May be administered undiluted or diluted in isotonic solution.
To minimize hypotension following IV administration, patient should remain in supine position under observation for ≥30 minutes. (See Hypotension under Cautions.)
Rate of Administration
Administer by IV infusion or by direct IV injection at a rate not exceeding 5 mg/minute.
Do not administer as a rapid (“bolus”) injection.
IM Administration
Administer by deep IM injection into the upper outer quadrant of the gluteus maximus.
If possible, avoid IM administration in geriatric patients who are thin or debilitated with reduced muscle mass (injections may be painful and absorption may be erratic or unpredictable).
Dosage
Available as prochlorperazine, prochlorperazine edisylate, or prochlorperazine maleate; dosage expressed in terms of prochlorperazine.
Pediatric Patients
Children should receive the lowest possible effective dosage, and parents should be instructed not to exceed the prescribed dosage.
Use not recommended in children <2 years of age or those weighing <9 kg.
Prescriptions for 2.5-mg pediatric suppositories should be written as “2 ½ mg” to avoid confusion with 25-mg adult suppositories.
Psychotic Disorders
Oral or Rectal
Children 2–12 years of age: Initially, 2.5 mg 2 or 3 times daily. Dosage may be increased according to patient’s therapeutic response and tolerance, but usually should not exceed 20 and 25 mg daily for children 2–5 and 6–12 years of age, respectively.
Dosage for children <2 years of age or those weighing <9 kg not established.
IM
Children <12 years of age: 0.13 mg/kg for prompt control of severe psychotic symptoms. Generally, most pediatric patients respond after 1 dose, and oral therapy should replace parenteral therapy at the same dosage level or higher.
Nausea and Vomiting
Oral or Rectal
Dosage for Treatment of Severe Nausea and Vomiting in Children ≥2 Years of Age
| Weight (kg) |
Daily Dosage |
| ≤9 |
Use not recommended |
| 9.1–13.2 |
2.5 mg once or twice daily |
| 13.6–17.7 |
2.5 mg 2 or 3 times daily |
| 18.2–38.6 |
2.5 mg 3 times daily or 5 mg twice daily |
Alternatively, in children ≥2 years of age and weighing >9 kg: 0.4 mg/kg or 10 mg/m2 daily given in 3 or 4 divided doses.
Generally, it is not necessary to continue therapy for >24 hours.
IM
Children ≥2 years of age and weighing >9 kg: 0.13 mg/kg. Generally, a single dose is sufficient to control nausea and vomiting in most patients.
Adults
Psychotic Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Oral
5 or 10 mg (as conventional tablets or oral solution) 3 or 4 times daily in office patients and outpatients with relatively mild symptomatology.
Initially, 10 mg (as conventional tablets or oral solution) 3 or 4 times daily for hospitalized or well-supervised patients with moderate to severe symptomatology. Gradually increase dosage every 2 or 3 days until symptoms are controlled or adverse effects become troublesome. Although some patients exhibit optimum response with 50–75 mg daily, dosages up to 150 mg daily may be required in severely disturbed patients.
IM
10–20 mg for prompt control in patients with severe symptomatology; may be necessary to repeat the initial dose every 1–4 hours to control symptoms in some patients. Generally, not more than 3 or 4 doses are required.
10–20 mg every 4–6 hours, if prolonged parenteral therapy is required.
After the patient’s symptoms are controlled, oral therapy should replace parenteral therapy at the same dosage level or higher.
Nonpsychotic Anxiety
Oral
5 mg (as conventional tablets or oral solution) 3 or 4 times daily for ≤12 weeks.
Alternatively, a dosage of 15 mg (as extended-release capsules) once daily upon arising or 10 mg (as extended-release capsules) every 12 hours may be used.
Nausea and Vomiting
Oral
Usually, 5 or 10 mg (as conventional tablets or oral solution) 3 or 4 times daily.
Alternatively, 15 mg (as extended-release capsules) once daily upon arising or 10 mg (as extended-release capsules) every 12 hours may be used; some patients subsequently may require a dosage of 30 mg (using the appropriate number of 10- or 15-mg extended-release capsules) once daily in the morning.
Dosages >40 mg daily should be used only in resistant cases.
Rectal
25 mg twice daily.
IV
2.5–10 mg.
For control of severe nausea and vomiting during surgery: 5–10 mg given 15–30 minutes before induction of anesthesia. If necessary, repeat initial dose once before surgery.
To control acute symptoms during or after surgery, usually 5–10 mg, repeated once, if necessary; single IV doses of the drug should not exceed 10 mg.
IM
Initially, 5–10 mg; if necessary, initial dose may be repeated every 3 or 4 hours, but total dosage should not exceed 40 mg daily.
For control of severe nausea and vomiting during surgery: 5–10 mg given 1–2 hours before induction of anesthesia. If necessary, dose may be repeated once, 30 minutes after the initial dose.
To control acute symptoms during or after surgery: 5–10 mg, repeated once in 30 minutes, if necessary.
Prescribing Limits
Pediatric Patients
Psychotic Disorders
Oral or Rectal
Maximum 10 mg daily for the first day.
Subsequently, maximum 20 and 25 mg daily for children 2–5 and 6–12 years of age, respectively.
Nausea and Vomiting
Oral or Rectal
Maximum Dosage for Treatment of Severe Nausea and Vomiting in Children ≥2 Years of Age
| Weight (kg) |
Maximum Daily Dosage |
| ≤9 |
Use not recommended |
| 9.1–13.2 |
Maximum 7.5 mg daily |
| 13.6–17.7 |
Maximum 10 mg daily |
| 18.2–38.6 |
Maximum 15 mg daily |
Adults
Nonpsychotic Anxiety
Oral
Maximum 20 mg daily; do not administer for >12 weeks.
Nausea and Vomiting
Oral
Dosages >40 mg daily should be used only in resistant cases.
IV
Maximum 10 mg as a single dose. Maximum 40 mg daily (total daily dosage).
IM
Maximum 40 mg daily (total daily dosage).
Special Populations
Geriatric Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Generally, select dose at lower end of recommended range; increase dosage gradually and monitor closely. (See Geriatric Use under Cautions.)
Debilitated or Emaciated Patients
Increase dosage gradually.
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