Codituss
Codituss is the first and only codeine based combination cough suppressant in a solid oral dosage form. In a 1,500 patient survey of their cold and flu symptoms, Codituss relieves the two most common symptoms reported by patients.
Importantly, Codituss does NOT contain promethazine. Promethazine is a first generation antihistamine that can create sedation and respiratory depression that is additive to the effects of codeine. Recently, FDA has ordered new labeling for promethazine and codeine combination products after reports of pediatric deaths associated with over dose of codeine w/promethazine.
The new FDA, black box warning states:
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.
|
Codituss does not have this stringent new age restriction and can be used in patients as young as twelve years of age because Codituss does not contain promethazine.
Interviews with MCO directors found that all were aware of this black box warning.
In interviews with practicing physicians, doctors liked the proposed codeine combination because it offers advantages to the patient in terms of efficacy, safety and convenience. Improved efficacy comes from combining two effective ingredients that treat the most common cough and cold symptoms simultaneously. The solid dosage form offers the safety advantage of more accurate dosing vs. liquids. Physicians also expect that these combinations will be safer due to less sedation and reduced over dose potential. Improved convenience comes from having two medicines in one tablet and from better portability versus a liquid.
|
