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 VC SYRUP
(PROMETHAZINE HYDROCHLORIDE, USP AND PHENYLEPHRINE HYDROCHLORIDE, USP)
Promethazine hydrochloride, a phenothiazine derivative. Phenylephrine hydrochloride is a sympathomimetic amine salt. Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; phenylephrine hydrochloride 5 mg.
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)
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.
Does Thiamine Help Vomiting and Nausea in Pregnancy? [Recruiting]
There are different treatments for nausea and vomiting in pregnancy. According to the ACOG
recommendations, promethazine is the first line of parenteral treatment after oral treatment
had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find
out whether thiamine helps the vomiting and nausea as well, by comparing the response to
thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.
Study to Evaluate Diphenhydramine in Children and Adolescents [Recruiting]
To characterize the pharmacokinetics of diphenhydramine in two pediatric populations:
children, ages 2 to < 12 years, and adolescents, ages 12 to < 18 years.
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Page last updated: 2009-01-21
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