PHENERGAN (PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
Each rectal suppository contains 12.5 mg or 25 mg promethazine HCl with ascorbyl palmitate, colloidal silicon dioxide, white wax, hard fat, and glyceryl monostearate. Phenergan (Promethazine HCl) Suppositories, USP are for rectal administration only.
PHENERGAN (Promethazine) is indicated for the following:
Phenergan (Promethazine HCl) Suppositories, USP are useful for:
Perennial and seasonal allergic rhinitis.
Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
Amelioration of allergic reactions to blood or plasma.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.
Preoperative, postoperative, or obstetric sedation.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.
Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.
Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
Published Studies Related to Phenergan (Promethazine)
Intravenous promethazine versus lorazepam for the treatment of peripheral vertigo
in the emergency department: A double blind, randomized clinical trial of
efficacy and safety. 
vertigo reduction compared with lorazepam in ED patients... CONCLUSION: Our study demonstrated the evidence that promethazine is superior to
Effects of single therapeutic doses of promethazine, fexofenadine and olopatadine
on psychomotor function and histamine-induced wheal- and flare-responses: a
randomized double-blind, placebo-controlled study in healthy volunteers. 
Since most first-generation antihistamines have undesirable sedative effects on
the central nervous systems (CNS), newer (second-generation) antihistamines have
been developed to improve patients' quality of life. However, there are few
reports that directly compare the antihistaminic efficacy and impairment of
Low-dose adrenaline, promethazine, and hydrocortisone in the prevention of acute adverse reactions to antivenom following snakebite: a randomised, double-blind, placebo-controlled trial. [2011.05]
CONCLUSIONS: Pretreatment with low-dose adrenaline was safe and reduced the risk of acute severe reactions to snake antivenom. This may be of particular importance in countries where adverse reactions to antivenom are common, although the need to improve the quality of available antivenom cannot be overemphasized.
A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. [2011.03]
OBJECTIVES: The objective of the study was to assess whether ondansetron has superior nausea reduction compared with metoclopramide, promethazine, or saline placebo in emergency department (ED) adults... CONCLUSIONS: Our study shows no evidence that ondansetron is superior to metoclopramide and promethazine in reducing nausea in ED adults. Early study termination may have limited detection of ondansetron's superior nausea reduction over saline. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial. [2010.05]
OBJECTIVE: To compare the effects of promethazine with those of metoclopramide for hyperemesis gravidarum... CONCLUSION: Promethazine and metoclopramide have similar therapeutic effects in patients who are hospitalized for hyperemesis gravidarum. The adverse effects profile was better with metoclopramide.
Clinical Trials Related to Phenergan (Promethazine)
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses [Completed]
The study was to determine if the drug worked to relieve nasal congestion experienced by
people with seasonal allergies.
A Dose Ranging Effect of Preoperative Diphenhydramine on Postoperative Quality of Recovery After Ambulatory Surgery [Recruiting]
Pain after ambulatory surgery remains an unsolved problem in The United States and Europe.
It is associated with delayed hospital discharge and it can result to an increased opioid
consumption with adverse side effects. The concept of multimodal analgesic technique was
introduced more than 15 years ago and several techniques have been studied over the years
including non steroidal antiinflammatory drugs (NSAIDs), acetaminophen, gabapentoids,
ketamine, local and regional anesthetic techniques. Histamine can have effects on polymodal
nociceptors and C-fibers, producing pain which is further increased by neurogenically
mediated release of substance P from afferent pain fibers. Several non-selective or H1
- selective histamine receptors antagonists have been demonstrated in animal models and
clinical pain. Chia et al demonstrated that preoperative promethazine had opioid sparing
properties without adverse sedative effects in patients undergoing abdominal hysterectomy.
Diphenhydramine is an anti-histamine drug who has been found to be effective in reducing
postoperative nausea and vomiting after ambulatory surgery but its effects on postoperative
pain and other important outcomes after ambulatory surgery such as time to meet discharge
criteria have not being studied.
The MQOR 40 is a validated instrument that was specifically design to evaluate patient
recovery after anesthesia and surgery. This instrument can be particularly valid to examine
interventions which affect different spheres of patient recovery as is the case of
diphenhydramine. The objective of this study is to determine a dose response effect of
preoperative diphenhydramine on postoperative quality of recovery after ambulatory surgery.
The use of preoperative diphenhydramine can improve patient's quality of recovery, decrease
postoperative pain, opioid consumption and opioid related side effects after ambulatory
The research question: Does a preoperative dose of diphenhydramine improve postoperative
quality of recovery after ambulatory surgery? The hypothesis of this study is that
preoperative diphenhydramine will improve postoperative pain, Postoperative nausea and
vomiting (PONV), sleep which will translate in a better overall quality of recovery.
Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea [Recruiting]
This randomized clinical trial studies lorazepam, diphenhydramine hydrochloride, and
haloperidol gel in patients with nausea. Lorazepam, diphenhydramine hydrochloride, and
haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and
Bioequivalence Between Two Oral Formulations of Diphenhydramine Hydrochloride [Completed]
The purpose of this study is to determine if two formulations of diphenhydramine
hydrochloride are bioequivalent.
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting [Recruiting]
This study is being done to determine the efficacies of two preventative drug combinations
for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this
study is to compare the efficacy of using aprepitant instead of ondansetron in combination
with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By
completing this comparison study investigators will determine the most efficacious drug
combination which will allow us to enhance the overall comfort and satisfaction of
neurosurgical patients in the immediate postoperative period.
Reports of Suspected Phenergan (Promethazine) Side Effects
Drug Ineffective (9),
Rash Pruritic (8),
Cerebrovascular Accident (8),
Eosinophilia (8), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Phenergan has an overall score of 5.50. The effectiveness score is 9 and the side effect score is 5. The scores are on ten point scale: 10 - best, 1 - worst.
Phenergan review by 42 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || Nausea|
|Dosage & duration:|| || 1 tablet by mouth every 6 hours taken once every other week for the period of 2 years|
|Other conditions:|| || Upset stomach|
|Other drugs taken:|| || Prilosec|
|Benefits:|| || The medication ease the nausea and my stomach was at ease for at more than a week. The medication relaxed the muscles in my stomach and released the gas trapped.|
|Side effects:|| || The medication made you very tired. Soon after taking the medication you fell asleep. After waking up, you feel groggy and tired. The feeling is like you didn't get enough sleep and you will feel this way all day.|
|Comments:|| || I was being treated for nausea cause by trapped gas in the stomach and intestines. |
Phenergan review by 42 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || nausea|
|Dosage & duration:|| || 1 pill taken once for the period of just once|
|Other conditions:|| || cancer|
|Other drugs taken:|| || procrit/epogen|
|Benefits:|| || Phenergan was given to combat nausea due to chemotherapy. Was given one pill in the ER to try and stop vomiting. It did ease the nausea a bit.|
|Side effects:|| || It made me feel like I couldn't sit still even though I was very weak from constant vomiting. I felt like I had bugs crawling all over my legs. I also had to keep moving my legs.|
|Comments:|| || One pill was given by mouth with water to ease nausea and vomiting. After about 20 minutes the side effects started.|
Page last updated: 2014-11-30