- TYLENOL WITH CODEINE NO. 3

TYLENOL WITH CODEINE NO. 3 - TAB

Posted Thursday 30 October 2008 - 09:38 AM by David Chan ( HIGH significance )

ATC Code

N02AA59

Warning

Janssen-Ortho Incorporated in collaboration with Health Canada would like to highlight new safety information regarding the use of TYLENOL with Codeine NO 2, 3, 4 and Elixir in nursing mothers and ultra-rapid metabolizers of codeine.

* Some individuals may be ultra-rapid metabolizers of codeine due to a specific CYP2D6 genotype.
* Breastfed babies of women who are ultra-rapid metabolizers are potentially at risk of dangerously high serum morphine levels due to higher-than-expected levels of morphine in the mother's breast milk.
* Mothers using codeine should be informed of signs and symptoms of morphine toxicity for themselves (constipation, oversedation) or their babies (drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone).
* Codeine-containing products should be prescribed at the lowest effective dose and for the shortest period of time.