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Rifampicin pharmacokinetics in children under the Revised National Tuberculosis Control Programme, India, 2009
1Department of Pharmacology, Maulana Azad Medical College, Lok Nayak Hospital, New Delhi, India.
Insights
Serum rifampicin (RMP) levels in children treated for tuberculosis (TB) were found to be low under India
Area of Science:
- Pharmacology
- Pediatric Tuberculosis
- Drug Dosing
Background:
- Tuberculosis (TB) remains a significant health concern in children.
- Accurate dosing of anti-TB drugs like rifampicin (RMP) is crucial for effective treatment.
- Current dosing guidelines may not adequately account for pediatric pharmacokinetic differences.
Purpose of the Study:
- To evaluate serum rifampicin (RMP) concentrations in children with TB.
- To assess RMP levels achieved with doses recommended by India's Revised National Tuberculosis Control Programme (RNTCP) 2009.
- To compare pediatric RMP pharmacokinetics with adult data.
Main Methods:
- Prospective, open-label, single-dose study.
- Involved 20 children aged 5-12 years treated at a tertiary care hospital in New Delhi.
- Serum RMP levels were measured at various time points post-administration.
Main Results:
- The median RMP dose administered was 9.56 mg/kg.
- Peak serum RMP concentration (Cmax) was 6.24 μg/ml, attained at 3.5 hours.
- RMP levels were significantly lower in children receiving <10 mg/kg compared to those receiving ⩾10 mg/kg (P < 0.05).
- A positive correlation was observed between RMP dose and Cmax (r(2) = 0.748).
- All patients had Cmax <8 μg/ml, considered sub-therapeutic.
Conclusions:
- Children under the RNTCP 2009 dosing system achieved low serum RMP concentrations.
- Pediatric RMP peak levels and elimination half-life appear shorter than in adults.
- RMP dosing in children requires revision to account for age-related pharmacokinetic variations for optimal treatment outcomes.
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 (Cmax) attained was 6.24 μg/ml (range 5.44-7.61) at time to Cmax 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 Cmax was observed (r(2) = 0.748). RMP Cmax was <8 μg/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.
