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Promethazine and Codeine (Promethazine Hydrochloride / Codeine Phosphate) - Summary

 

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BOX 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.

 

SUMMARY

PROMETHAZINE HYDROCHLORIDE, USP AND CODEINE PHOSPHATE, USP SYRUP Rx Only

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.

NEWS HIGHLIGHTS RELATED TO PROMETHAZINE AND CODEINE

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]

Effects of chronic administration of codeine and promethazine on breathlessness and exercise tolerance in patients with chronic airflow obstruction. [1987.07]

Beliefs and social norms about codeine and promethazine hydrochloride cough syrup (CPHCS) use and addiction among multi-ethnic college students. [2007.09]

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]

more>>

Clinical Trials Related to Promethazine and Codeine (Promethazine / Codeine)

Post Burn Pruritus Study in Patients Undergoing Wound Healing [Completed]

A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department [Completed]

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED [Recruiting]

Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy in Young Patients With Newly Diagnosed Cancer [Recruiting]

Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine [Not yet recruiting]

more>>

Page last updated: 2008-06-22

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