High dose artesunate in combination with mefloquine: pharmacovigilance in the Venezuelan Amazon.

Authors:
Address: Amazon Center for the Investigation and Control of Tropical Diseases Simón Bolívar, Autonomous Service (SACAICET), Puerto Ayacucho, Amazon State, Venezuela. wgmetzger@yahoo.com
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abstract

Forty-six patients in a remote health post of Amazonas, Venezuela, accidentally received artesunate in a dose of 10 mg/kg/day combined with mefloquine. This corresponds to the upper limit of the therapeutic range recommended by the WHO (2-10 mg/kg/day). Side effects were retrospectively investigated and a pharmacovigilance report was written. The main side effects were vomiting and diarrhea. Four patients developed complications with signs of dehydration. It is suggested to re-assess the therapeutic range of artesunate when given in combination with mefloquine and to establish a worldwide centralized antimalarial toxicity reporting system.

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