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Free Content Low plasma concentrations of rifampicin in tuberculosis patients in Indonesia

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SETTING: Although rifampicin is a key drug in tuberculosis treatment, little is known about its quality and bioavailability in countries endemic for tuberculosis. High drug levels may lead to increased toxicity, while low drug levels may predispose to treatment failure and relapse.

OBJECTIVE: To investigate possible variations in the bioavailability of plasma rifampicin in tuberculosis patients in Indonesia.

DESIGN: Plasma concentrations of rifampicin and the rifampicin content of drug formulations in use were measured among 62 non-selected tuberculosis patients in Jakarta, Indonesia.

RESULTS: Plasma concentrations of rifampin were generally low: 70% of patients had 2-hour plasma concentrations (Cmax) below 4 mg/L. No toxic plasma concentrations of rifampicin (>20 mg/L) were found. The strongest predictive factor for the magnitude of rifampicin concentrations was the drug manufacturer. The rifampicin content of the different drug preparations used was normal (90.5–103.6% of the reference standard). No association was found between low plasma rifampicin concentrations and delayed sputum conversion or treatment failure.

CONCLUSION: The unexpectedly low plasma concentrations of rifampicin in this setting are most likely due to reduced bioavailability of local drug preparations, as the rifampicin content of the drug preparations was found to be normal. The clinical significance of these findings remains to be determined.
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Keywords: Indonesia; biological bioavailability; clinical pharmacology; rifampicin; tuberculosis treatment

Document Type: Regular Paper

Affiliations: 1: Department of Internal Medicine, University Medical Centre Nijmegen, The Netherlands 2: Department of Internal Medicine, Padjadjaran University, Bandung, Indonesia 3: Department of Pulmonary Medicine, University Medical Centre Nijmegen, The Netherlands 4: Perkumpulan Pemberantasan Tuberkulosa Indonesia (PPTI), Jl Baladewa, Jakarta, Indonesia 5: Department of Clinical Pharmacology, University Medical Centre Nijmegen, The Netherlands 6: Working Group on Infectious Diseases, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia

Publication date: June 1, 2002

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on lung health world-wide.

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