Blood Levels of Pyrazinamide in Children at Doses Administered Under the Revised National Tuberculosis Control Program.
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Date
2012-09
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Abstract
Objectives: To evaluate the blood levels, pharma-cokinetics
and pharmacodynamic indices of pyrazinamide (PZA) in
children suffering from tuberculosis, at doses administered
under the weight band system of Revised National Tuberculosis
Control Program of India (RNTCP) of India.
Design: Prospective, open-label, non-randomized single-dose
study.
Setting: 20 children in the age group 5-12 years attending outpatient
tuberculosis clinic of a tertiary hospital.
Outcome Measures: Blood levels of pyrazinamide after single
dose administration, as per the weight band system of RNTCP.
Results: Group I (n=7) included children who received
pyrazinamide within the recommended 30-35 mg/kg dose
(mean 31.9+0.8 mg/kg) and Group II (n=13) included those who
received a dose lower than 30 -35 mg/kg (mean 28.1±0.3 mg/
kg). The Cmax (95% CI of difference 2.2, 13.2; P=0.008) and AUC
(95% CI of difference 28.6, 208.1; P=0.01) were significantly
lower in Group II. The duration of time for which the
concentration was maintained above 25 μg ml-1 was 4-8 h in
Group I and 3-5.5 h in Group II (95% CI of difference 0.1, 2.0;
P=0.03). The half life, elimination rate constant, clearance and
volume of distribution were comparable in the two groups. The
ratios of Cmax and AUC to MIC (25 μg ml-1) in children were lower
than that recommended for PZA in adults.
Conclusions: Lower blood concentrations are being attained in
children receiving PZA doses under the existing weight band
system of RNTCP of India. The weight bands may need to be
revised and dose recommendations be based on
pharmacokinetic and efficacy data in children.
Description
Keywords
Children, India, Pharmacokinetics, Pyrazinamide, RNTCP, Tuberculosis
Citation
Roy V, Sahni P, Gupta P, Sethi G R, Khanna A. Blood Levels of Pyrazinamide in Children at Doses Administered Under the Revised National Tuberculosis Control Program. Indian Pediatrics. 2012 September; 49(9): 721-725.