Prochlorperazine (Prochlorperazine Maleate) - Summary

SUMMARY

PROCHLORPERAZINE MALEATE TABLETS USP

Rx only

Prochlorperazine maleate is classified as an antiemetic and antipsychotic agent.

Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 mg of prochlorperazine.

Prochlorperazine is indicated for the following:

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 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

Randomized evaluation of octreotide vs prochlorperazine for ED treatment of migraine headache. [2009.02]
Patients with headaches account for approximately 2% of all ED visits, with migraines being the most common defined primary headache syndrome. Our goals were to evaluate the efficacy of intravenous octreotide (OC) for the treatment of migraines, when compared to standard therapy with prochlorperazine... CONCLUSION: Prochlorperazine was statistically superior to octreotide in clinical success rate and decrease in pain in migraine patients but caused more restlessness and sedation.

Clinical Outcomes of Children Treated with Intravenous Prochlorperazine for Migraine in a Pediatric Emergency Department. [2009.01.14]
Background: Prochlorperazine is the only treatment that has been studied so far in a randomized controlled trial and found to reduce pain at 1 h in children with migraine who presented to an emergency department (ED). Objective: To evaluate the rate of treatment failure associated with prochlorperazine used in children with severe migraine in a pediatric ED...

Prochlorperazine vs. promethazine for headache treatment in the emergency department: a randomized controlled trial. [2008.10]
Headache is a very common medical complaint. Four to six percent of the population will have a debilitating headache in their lifetime; and 1-2% of all Emergency Department (ED) visits involve patients with headaches... Prochlorperazine was superior to promethazine in the rate of headache reduction and rate of home drowsiness, with similar rates of akathesia, nausea resolution, patient satisfaction, and headache recurrence within 5 days of discharge.

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.

Prochlorperazine vs. Promethazine for Headache Treatment in the Emergency Department: A Randomized Controlled Trial. [2008.06.04]
Headache is a very common medical complaint. Four to six percent of the population will have a debilitating headache in their lifetime; and 1-2% of all Emergency Department (ED) visits involve patients with headaches... Prochlorperazine was superior to promethazine in the rate of headache reduction and rate of home drowsiness, with similar rates of akathesia, nausea resolution, patient satisfaction, and headache recurrence within 5 days of discharge.

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Clinical Trials Related to Prochlorperazine

Staccato® 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]

Staccato® 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.

Staccato Prochlorperazine Thorough QT/QTc Study [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

Prochlorperazine review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		nausea
Dosage & duration:		5mg taken 3 daily for the period of 2 days
Other conditions:		migraine
Other drugs taken:		none
		Reported Results
Benefits:		i was experiencing nausea without vomiting. The doctor prescribed stemetil 3x daily. The first day the nausea was largely alleviated by the taking the stemetil.
Side effects:		The second day of taking stemetil i began to experience unpleasant anxiety and a cramping sensation in my muscles, particularly my arms. This worsened throughout the day and I found myself uncontrollably flexing my muscles and not being able to control it.
Comments:		My GP prescribed stemetil for the nausea associated with a migraine. 5 mg x 3 a day. After experiencing the symptoms as described above, I returned to the Doctor. He injected me with something? which counteracted the uncontrollable cramping I was experiencing.