WHO recommends and endorses the use of fixed-dose combinations and the development of appropriate new fixed-dose combinations, including modified dosage forms, non-refrigerated products and paediatric dosage forms of assured pharmaceutical quality.
Summary of evidence and Expert Committee recommendations
The EMLc Subcommittee did not endorse the inclusion of this fixed-dose combination for the treatment of tuberculosis on the EMLc.
The various fixed-dose combinations were considered as a group, as there
is no clinical evidence for any of these combinations in children. However,
it is difficult to determine the necessary appropriate combinations and
what the strengths of the components should be in FDCs for use in children
without examining further data (including pharmacokinetic data, stratified
by weight and age). The Subcommittee therefore decided to endorse the
lower strength rifampicin + isoniazid combinations (60 mg + 30 mg
and 60 mg + 60 mg) and rifampicin + isoniazid + pyrazinamide (60 mg
+ 30 mg + 150 mg) as probably useful for many children, but requested
an urgent review of all clinical evidence to support these and other