SUMMARY
Prochlorperazine Edisylate Injection, USP
Rx only
Prochlorperazine Edisylate Injection, an antiemetic and antipsychotic, is a sterile solution intended for intramuscular or intravenous administration.
Each mL contains prochlorperazine 5 mg as the edisylate, monobasic sodium phosphate monohydrate 5 mg, sodium tartrate dihydrate 12 mg, saccharin sodium 0.9 mg and benzyl alcohol 7.5 mg in Water for Injection. pH 4.2-6.2.
Prochlorperazine Edisylate (prochlorperazine) is indicated for the following:
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.
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NEWS HIGHLIGHTS
Published Studies Related to Prochlorperazine Injection
A randomized controlled trial of prochlorperazine versus metoclopramide for treatment of acute migraine. [2008.10]
STUDY OBJECTIVE: We compare prochlorperazine 10 mg intravenously versus metoclopramide 20 mg intravenously for the emergency department (ED) treatment of acute migraine... CONCLUSION: Either prochlorperazine 10 mg intravenously or metoclopramide 20 mg intravenously, combined with diphenhydramine 25 mg intravenously, is an efficacious treatment for ED patients with acute migraine. Three quarters of subjects in both arms would want the same medication for their next migraine.
Droperidol vs. prochlorperazine for benign headaches in the emergency department. [2001.09]
OBJECTIVE: To compare the efficacy of droperidol with that of prochlorperazine for the treatment of benign headaches in emergency department (ED) patients... CONCLUSIONS: Droperidol was more effective than prochlorperazine in relieving pain associated with benign headaches.
The prophylactic antiemetic efficacy of prochlorperazine and ondansetron in nasal septal surgery: a randomized double-blind comparison. [1996.10]
A prospective, randomized placebo-controlled study was undertaken to compare the effects on heart rate and blood pressure during surgery and on the incidence of nausea, vomiting and headache after surgery of i.m.
Intramuscular prochlorperazine versus metoclopramide as single-agent therapy for the treatment of acute migraine headache. [1996.05]
To compare the efficacy of intramuscular prochlorperazine and metoclopramide in the short-term treatment of migraine headache in the emergency department 86 eligible adult patients with moderate to severe migraine headache were evaluated prospectively at a university-affiliated community hospital...
Comparison of ondansetron and prochlorperazine for the prevention of nausea and vomiting after adenotonsillectomy. [1996.03]
This study has compared the incidences of nausea, vomiting and headache after ondansetron 0.06 mg kg-1 i.v., prochlorperazine 0.2 mg kg-1 i.m...
Clinical Trials Related to Prochlorperazine Injection
StaccatoŽ Prochlorperazine for Inhalation [Completed]
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department [Completed]
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR
imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is
improvement in pain scales between the groups.
Staccato Prochlorperazine in Patients With Migraine Headache [Completed]
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department [Recruiting]
This study will compare the effect of prochlorperazine and ondansetron for the treatment of
nausea and vomiting in the emergency department.
StaccatoŽ Prochlorperazine for Inhalation in Migraine [Completed]
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine
headaches. In October 2005, we completed a 75 patient, multi-center, double-blind
placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe
acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been
initiated to assess the efficacy and safety in outpatients with migraine headache with or
without aura.
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