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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.


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NEWS HIGHLIGHTS

Media Articles Related to Promethazine

promethazine and codeine, Phenergan with Codeine
Source: MedicineNet Common Cold Specialty [2009.10.13]
Title: promethazine and codeine, Phenergan with Codeine
Category: Medications
Created: 3/26/1998 2:30:00 PM
Last Editorial Review: 10/13/2009

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Published Studies Related to Promethazine

Influence of promethazine on cardiac repolarisation: a double-blind, midazolam-controlled study. [2009.06]
Drugs used in anaesthesia may provoke torsadogenic changes in cardiac repolarisation. The aim of this study was to assess the effect of promethazine on the parameters of ventricular repolarisation: QTc interval and transmural dispersion of repolarisation... In conclusion, promethazine induces significant QTc prolongation but the lack of influence on transmural dispersion of repolarisation makes the risk of its torsadogenic action very low.

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.

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.

Rapid tranquillisation in psychiatric emergency settings in Brazil: pragmatic randomised controlled trial of intramuscular haloperidol versus intramuscular haloperidol plus promethazine. [2007.10.27]
OBJECTIVE: To determine whether haloperidol alone results in swifter and safer tranquillisation and sedation than haloperidol plus promethazine... CONCLUSIONS: Haloperidol plus promethazine is a better option than haloperidol alone in terms of speed of onset of action and safety. Enough data are now available to change guidelines that continue to recommend treatments that leave people exposed to longer periods of aggression than necessary and patients vulnerable to distressing and unsafe adverse effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN83261243 [controlled-trials.com].

Effects of ethanol and promethazine on awareness of errors and judgements of performance. [2006.09]
Ethanol may affect detection and processing of errors in performance tasks, and thus influence the speed accuracy trade-off. In this double-blind study, 11 volunteers, (seven female, four male) took part in four sessions in which they received ethanol (Eth; mean blood alcohol concentration at 60 min: 87.3, SD: 18.4), placebo (Pla), promethazine 20mg (P20) and 30 mg (P30) in randomized order.

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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.

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.

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department [Completed]
This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED [Recruiting]

Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) [Recruiting]
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.

more trials >>

Page last updated: 2009-10-20

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