BOX WARNING
BOXED WARNING:
THE COMBINATION OF PROMETHAZINE HYDROCHLORIDE AND
CODEINE PHOSPHATE IS CONTRAINDICATED IN PEDIATRIC
PATIENTS LESS THAN 6 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
Promethazine is a neuroleptic drug and a first-generation antihistamine of the phenothiazine family.
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 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)
Study of Promethazine for Treatment of Diabetic Gastroparesis [Recruiting]
Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed
gastric emptying will be recruited to participate in the study. Using double-blinded
methodology, study participants will be randomly assigned to one of two treatment arms:
promethazine 12. 5 mg three times daily for 28 days or placebo three times daily for 28 days.
The primary outcome will be the change in gastroparesis symptom severity, as measured by
the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline.
Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom
scores, adverse events and treatment compliance will be assessed. It is hypothesized
promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.
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.
Effect of Hyoscine and Promethazine on Labor Pain [Completed]
It is always considered to shorten the duration of delivery without compromising the mother
and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research
is very limited, with conflicting results regarding the efficacy of these two drugs. So the
investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on
length of active phase of the first stage of labor.
Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine [Active, not recruiting]
Promethazine vs. Lorazepam for Treatment of Vertigo [Completed]
This study was a prospective, randomized, double-blind, parallel group clinical trial
designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the
treatment of peripheral vertigo in Emergency Department setting.
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Page last updated: 2008-06-22
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