If you are:
FDB Only When Necessary: INSUFF HUMAN DATA; BASED ON PHARMACOLOGY DEV TOX POSSIBLE
Absolute Contraindication: POTENTIAL FOR SERIOUS ADVERSE EFFECTS BASED ON DRUG PHARMACOLOGY
An adult over 60:
management or monitoring precaution: General-Increased sensitivity to effects and may require lower dose regimen. Renal-May need to reduce the dose for CrCL< 60 mL/min.
Giving Droxia to a child under 12:
management or monitoring precaution: Safety and efficacy not established.