WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoREGULATORY MATTERS
Cerrar esta carpetaSAFETY OF MEDICINES
Ver el documentoATAZANAVIRRITONAVIR - Not to be coadministered with omeprazole
Ver el documentoCELECOXIB - Increased risk of cardiovascular events
Ver el documentoDARBEPOETIN ALFA - Adverse outcomes associated with off-label dosing strategies
Ver el documentoGALANTAMINE - Ineffective and possibly unsafe in mild cognitive impairment
Ver el documentoGLUCOSAMINE - Concerns about hypercholesterolaemic effects
Ver el documentoNAPROXEN - Long-term study indicates cardiovascular risk
Ver el documentoNEVIRAPINE - Not recommended in women with CD4+ cell counts greater than 250 cells/mm3
Ver el documentoPROPOFOL - Adverse events with both low- and high-rate infusions
Ver el documentoROSUVASTATIN - More reports of rhabdomyolysis
Abrir esta carpeta y ver su contenidoDRUGS OF CURRENT INTEREST
Abrir esta carpeta y ver su contenidoFEATURE
 

ATAZANAVIRRITONAVIR - Not to be coadministered with omeprazole

Europe. The European Medicines Agency (EMEA) has issued a public statement that warns physicians against the co-administration of atazanavir (Reyataz) combined with ritonavir (RTV) and 40 mg omeprazole, a proton pump inhibitor. This warning is based on the observations from a randomized, open-label, multiple-dose drug interaction study performed in healthy volunteers. The study demonstrated a 76% reduction in atazanavir area under the concentration curve (AUC) and a 78 % reduction in atazanavir trough plasma concentration (Cmin) when atazanavir/ ritonavir (300/100 mg) was coadministered with omeprazole 40 mg. The exact mechanism for this interaction is yet to be determined. In the meantime, physicians are advised not to co-administer atazanavir/ ritonavir (300/100 mg) with any dose of omeprazole or with any other proton pump inhibitor to avoid risk of reduction in the atazanavir exposure levels in these patients.

Reference:

EMEA Public Statement, EMEA/CHMP/202649/2004, 21 December 2004. Available on the Internet at www.emea.eu.int

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