Reconstitution of PwB for BPaLM regimen

Pediatric Shorter oral MDR/RR PwB

9-month shorter oral MDR/RR-TB regimen

• The constitution of the IP box of the shorter oral MDR/RR-TB regimen will be the same as detailed in the Guidelines for PMDT in India - 2021, except replacement of four months of Eto with two months of Lzd in the IP, as applicable. 
• Thus, 63 tablets of Lzd (600 mg) to cover the initial nine weeks are to be added to the initial monthly PWBs in place of the entire quantity of Eto. 
• Rest of the composition of the monthly IP and CP boxes would be the same as detailed in the Guidelines for PMDT in India - 2021.
• A child-friendly formulation of Bdq (20 mg scored uncoated dispersible tablet [DT]) is now available and approved by DCGI for children and adults. 
• Indirect bioequivalence testing of Bdq 20 mg DT child friendly and Bdq 100 mg adult formulations showed that both tablets have the same bioavailability and can be used interchangeably at the same total dose