BOX WARNING WARNING
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC PATIENTS LESS THAN 16 YEARS OF AGE. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.
POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
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SUMMARY
Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%.
Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic.
Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride.
Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
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NEWS HIGHLIGHTS
Published Studies Related to Promethazine and Codeine (Promethazine / Codeine)
Comparison of the efficacy of paracetamol versus paracetamol, codeine and promethazine (Painstop) for premedication and analgesia for myringotomy in children. [1997.02]
This prospective double-blinded study compared the analgesic effectiveness and incidence of complications of a compound preparation Painstop (Paedpharm Pty Ltd) containing paracetamol 12 mg, codeine 0.5 mg and promethazine 0.65 mg per 1.0 ml, dosage 1.0 ml/kg, with paracetamol 20 mg/kg... Pain scores were low and similar in both groups and the need for additional analgesia was uncommon.
Effects of chronic administration of codeine and promethazine on breathlessness and exercise tolerance in patients with chronic airflow obstruction. [1987.07]
It has been reported that short-term treatment with relatively high doses of opiates or promethazine causes improvements in dyspnoea and exercise tolerance in patients with chronic airflow obstruction (CAO). This study was designed to determine whether initial benefits were sustained during chronic administration of codeine or promethazine and to compare the two drugs in terms of their efficacy and possible mechanisms of action...
Beliefs and social norms about codeine and promethazine hydrochloride cough syrup (CPHCS) use and addiction among multi-ethnic college students. [2007.09]
In this study a qualitative approach is used to investigate relevant beliefs and norms concerning the consumption, initiation, and perceived addiction of codeine and promethazine hydrochloride cough syrup (CPHCS) among 61 college-age students who identified themselves as current CPHCS users.A majority of students believed that their friends felt codeine promethazine use was "normal" and "cool" among college students their age, and that reinforcing factors, such as peer pressure and curiosity, contributed to initial CPHCS use.
Beliefs and social norms about codeine and promethazine hydrochloride cough syrup (CPHCS) onset and perceived addiction among urban Houstonian adolescents: an addiction trend in the city of lean. [2003]
In the current study, we used a qualitative approach to investigate relevant beliefs and norms associated with codeine and promethazine hydrochloride cough syrup (CPHCS) consumption, initiation, and perceived addiction among 48 alternative school students who identified themselves as current CPHCS users...
Clinical Trials Related to Promethazine and Codeine (Promethazine / Codeine)
Post Burn Pruritus Study in Patients Undergoing Wound Healing [Completed]
The purpose of this study is to see if a drug called ondansetron (Zofran) controls itching
from healing burn wounds as well or better than the usual drug used, diphenhydramine
(Benadryl).
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.
Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy in Young Patients With Newly Diagnosed Cancer [Recruiting]
RATIONALE: Diphenhydramine, lorazepam, and dexamethasone may help lessen or prevent nausea
and vomiting in patients treated with chemotherapy. It is not yet known whether
diphenhydramine, lorazepam, and dexamethasone are more effective than standard therapy in
treating nausea and vomiting caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying diphenhydramine, lorazepam, and
dexamethasone to see how well they work compared with standard therapy in treating nausea and
vomiting caused by chemotherapy in young patients with newly diagnosed cancer.
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Page last updated: 2008-06-22
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