BOX WARNING
WARNING:
PROMETHAZINE HYDROCHLORIDE 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 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.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
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SUMMARY
Promethazine is a neuroleptic drug and a first-generation antihistamine of the phenothiazine family.
Promethazine hydrochloride and phenylephrine hydrochloride syrup is indicated for the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
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NEWS HIGHLIGHTS
Clinical Trials Related to Promethazine VC (Promethazine / Phenylephrine)
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: 2012-08-31
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