BOX WARNING
PHENERGAN 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 PHENERGAN IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PHENERGAN HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PHENERGAN TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
|
| |
PHENERGAN SUMMARY
Phenergan®
(promethazine HCI)
Tablets and Suppositories
Phenergan (promethazine HCl) is an H1 receptor blocking agent.
Phenergan, either orally or by suppository, is useful for:
Perennial and seasonal allergic rhinitis.
Vasomotor 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.
Dermographism.
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 post-operative 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.
|
NEWS HIGHLIGHTSMedia Articles Related to Phenergan (Promethazine)
promethazine and codeine, Phenergan with Codeine
Source: MedicineNet Chronic Cough 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
Published Studies Related to Phenergan (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.
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.
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.
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.
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine [Not yet recruiting]
This is a non-interventional retrospective data collection study from children aged from 2 to
12 years old diagnosed with an allergy and who received a treatment consisting of an
H1-antihistamine. The period of last taken medication will be observed to evaluate the global
satisfaction of the parents and physician for this last treatment.
Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED [Recruiting]
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Phenergan has an overall score of 2. The effectiveness score is 8 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Phenergan review by 42 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | nausea |
| Dosage & duration: | | 1 pill taken once for the period of just once |
| Other conditions: | | cancer |
| Other drugs taken: | | procrit/epogen | | |
Reported Results |
| 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: 2009-10-20
|
