Label Changes for:
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2010
USE IN SPECIFIC POPULATIONS
- In a pharmacokinetic study conducted in 2 to 12 year-old pediatric patients, the exposure to rifapentine (i.e., AUC and Cmax observed in healthy adults.