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.
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.
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. 
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)
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.
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
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.