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ATC codes: J04AM06
Indication
Tuberculosis ICD11 code: 1B4Z
INN
Ethambutol + isoniazid + pyrazinamide + rifampicin
Medicine type
Chemical agent
List type
Core 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.
Formulations
Oral > Solid: 275 mg + 75 mg + 400 mg + 150 mg tablet
EML status history
First added in 1999 (TRS 895)
Changed in 2007 (TRS 950)
Sex
All
Age
Adolescents and adults
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
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 potential combinations.