DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE and
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism.
Concomitant Use with Benzodiazepines, CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough
medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
INDICATIONS AND USAGE
TUZISTRA XR is a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H1) receptor
antagonist indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold.
Limitation of Use: Not indicated for pediatric patients under 18 years of age.