Rifampicin pharmacokinetics in children under the Revised National Tuberculosis Control Programme, India, 2009

OBJECTIVE: To evaluate serum levels of rifampicin (RMP) in children with tuberculosis (TB) at doses administered according to India's Revised National Tuberculosis Control Programme (RNTCP) 2009 report. METHOD: Prospective, open label, non-randomised single-dose study in 20 children aged 5-12 years. SETTING: The out-patient chest clinic of a tertiary care hospital, New Delhi, India. RESULTS: The median RMP dose administered was 9.56 mg/kg (range 9-12.64). Peak RMP concentration (Cm) attained was 6.24 mu g/ml (range 5.44-7.61) at time to C-max of 3.5 h (range 3-4). RMP levels were significantly lower at 2,3 and 4 h in children administered <10 mg/kg than those who received >= 10 mg/kg (P < 0.05). A positive correlation between the RMP dose administered and C-max was observed (r(2) = 0.748). RMP C-max was <8 mu g/ml in all patients, a level considered too low for therapeutic efficacy. CONCLUSIONS: Low serum concentrations of RMP were attained in children under the RNTCP 2009 weight band system. Peak RMP levels appear to be lower and the single dose elimination half-life shorter in children than in adults. To optimise treatment outcomes, revisions in RMP dose in children should take into consideration age-related differences in pharmacokinetics.