PROCHLORPERAZINE MALEATE TABLETS USP
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.
Published Studies Related to Prochlorperazine
Randomized Controlled Trial of Ondansetron vs. Prochlorperazine in Adults in the Emergency Department. [2011.02]
OBJECTIVE: To compare the effectiveness of ondansetron and prochlorperazine to treat vomiting. Secondary objectives were the effectiveness of ondansetron and prochlorperazine to treat nausea and their tolerability... CONCLUSION: Prochlorperazine and ondansetron appear to be equally effective at treating vomiting in the emergency department.
Clinical outcomes of children treated with intravenous prochlorperazine for migraine in a pediatric emergency department. [2010.08]
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... CONCLUSION: There was a treatment failure rate of 14% with the use of prochlorperazine in association with diphenhydramine for severe migraine in children seen in a pediatric ED. Copyright 2010 Elsevier Inc. All rights reserved.
A prospective, randomized trial of intravenous prochlorperazine versus subcutaneous sumatriptan in acute migraine therapy in the emergency department. [2010.07]
STUDY OBJECTIVE: Intravenous (IV) prochlorperazine with diphenhydramine is superior to subcutaneous sumatriptan in the treatment of migraine patients presenting to the emergency department (ED)... CONCLUSION: IV prochlorperazine with diphenhydramine is superior to subcutaneous sumatriptan in the treatment of migraine. Copyright 2009 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.
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...
Clinical Trials Related to Prochlorperazine
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
Reports of Suspected Prochlorperazine Side Effects
Drug Ineffective (15),
Cerebrovascular Accident (13),
Rash Pruritic (12),
Blood Cholesterol Increased (11),
Rash Pustular (11), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Prochlorperazine has an overall score of 2. The effectiveness score is 6 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
Prochlorperazine review by 36 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Moderately Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || nausea|
|Dosage & duration:|| || 5mg taken 3 daily for the period of 2 days|
|Other conditions:|| || migraine|
|Other drugs taken:|| || none|
|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. |
Page last updated: 2011-12-09