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Blood levels of pyrazinamide in children at doses administered under the Revised National Tuberculosis Control

V Roy1, P Sahni, P Gupta

  • 1Department of Pharmacology, Maulana Azad Medical College and Associated Hospitals, Bahadurshah Zafar Marg, New Delhi 110 002, India. roy.vandana@gmail.com

Indian Pediatrics
|February 10, 2012
PubMed

Insights

Pediatric tuberculosis treatment may be suboptimal, as children receiving pyrazinamide (PZA) under India's RNTCP weight band system achieved lower blood concentrations. Dosing adjustments based on pharmacokinetic data are recommended for improved efficacy.

Area of Science:

  • Pharmacology and Therapeutics
  • Pediatric Infectious Diseases
  • Tuberculosis Research

Background:

  • Pyrazinamide (PZA) is a crucial first-line anti-tuberculosis drug.
  • Accurate dosing in pediatric populations is essential for effective treatment and preventing drug resistance.
  • The Revised National Tuberculosis Control Program (RNTCP) in India utilizes a weight band system for PZA dosage.

Purpose of the Study:

  • To assess pyrazinamide (PZA) blood concentrations, pharmacokinetics, and pharmacodynamics in children with tuberculosis.
  • To evaluate PZA doses administered according to the RNTCP weight band system in India.
  • To determine if current dosing achieves therapeutic levels in pediatric TB patients.

Main Methods:

  • A prospective, open-label, non-randomized single-dose study was conducted.
  • Twenty children aged 5-12 years with tuberculosis were enrolled from a tertiary hospital's outpatient clinic.
  • Blood PZA levels were measured post-administration according to RNTCP weight bands.

Main Results:

  • Children receiving lower PZA doses (mean 28.1 mg/kg) had significantly lower peak concentrations (Cmax) and area under the curve (AUC) compared to those within the recommended range (mean 31.9 mg/kg).
  • The duration of PZA concentration above the minimum inhibitory concentration (MIC) of 25 µg/mL was shorter in the lower-dose group (3-5.5 hours) versus the recommended-dose group (4-8 hours).
  • Key pharmacokinetic parameters like half-life and clearance were similar between groups, but ratios of Cmax and AUC to MIC were below adult recommendations.

Conclusions:

  • The current RNTCP weight band system for PZA may result in sub-therapeutic blood concentrations in children.
  • Revising weight bands and basing PZA dosage recommendations on pediatric pharmacokinetic and efficacy data is warranted.
  • Optimizing PZA dosing in children is critical for successful tuberculosis treatment outcomes.
Abstract

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