EMA recommends changes to vancomycin prescribing information

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The European Medicines Agency (EMA) has recommended changes to prescribing information for vancomycin.

As part of a strategy to update product information of older antibacterial agents, the EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed available data on vancomycin. Based on current evidence, it concluded that the use of oral vancomycin should be limited to the treatment of Clostridium difficile infections.

The committee also stated that available data do not adequately support the use of vancomycin for staphylococcal enterocolitis or for GI decontamination in immunocompromised patients. Vancomycin infusion is still recommended for the complicated soft-tissue, bone and joint infections, pneumonia, infective endocarditis, acute bacterial meningitis, and bacteraemia associated with these infections. It can also be used prophylactically in patients at risk for bacterial endocarditis and for the treatment of dialysis-associated peritonitis.

The Committee has recommended a change in relation to dosage of vancomycin infusion. The updated recommendations are based on data which showed that previously recommended doses often resulted in suboptimal levels of vancomycin serum concentrations.

The CHMP opinion will now be forwarded to the European Commission for consideration.

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