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Promethazine (Promethazine Hydrochloride) - Summary

 
 



BOXED WARNING

WARNING: PROMETHAZINE HCl INJECTION 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 INJECTION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl INJECTION HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl INJECTION BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

 

PROMETHAZINE SUMMARY

Promethazine HCl Injection, USP

Promethazine HCl Injection USP is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration.

Promethazine HCl Injection is indicated for the following conditions:

  1. Amelioration of allergic reactions to blood or plasma.

  2. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.

  3. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.

  4. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.

  5. Active treatment of motion sickness.

  6. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.

  7. As an adjunct to analgesics for the control of postoperative pain.

  8. Preoperative, postoperative, and obstetric (during labor) sedation.

  9. Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.


See all Promethazine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Promethazine

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. [2012]
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 psychomotor functions...

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.

A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. [2010.03.24]
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) 2010 Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to 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 surgery.

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.

Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department [Not yet recruiting]
Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.

Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine [Recruiting]

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 vomiting.

more trials >>

Reports of Suspected Promethazine Side Effects

Completed Suicide (42)Toxicity TO Various Agents (33)Respiratory Arrest (17)Cardiac Arrest (17)Headache (11)Somnolence (11)Nausea (11)Overdose (10)Dizziness (10)Drug Ineffective (9)more >>


Page last updated: 2013-02-10

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