WHO Pharmaceuticals Newsletter 2005, No. 01
(2005; 12 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuREGULATORY MATTERS
Fermer ce répertoireSAFETY OF MEDICINES
Afficher le documentATAZANAVIRRITONAVIR - Not to be coadministered with omeprazole
Afficher le documentCELECOXIB - Increased risk of cardiovascular events
Afficher le documentDARBEPOETIN ALFA - Adverse outcomes associated with off-label dosing strategies
Afficher le documentGALANTAMINE - Ineffective and possibly unsafe in mild cognitive impairment
Afficher le documentGLUCOSAMINE - Concerns about hypercholesterolaemic effects
Afficher le documentNAPROXEN - Long-term study indicates cardiovascular risk
Afficher le documentNEVIRAPINE - Not recommended in women with CD4+ cell counts greater than 250 cells/mm3
Afficher le documentPROPOFOL - Adverse events with both low- and high-rate infusions
Afficher le documentROSUVASTATIN - More reports of rhabdomyolysis
Ouvrir ce répertoire et afficher son contenuDRUGS OF CURRENT INTEREST
Ouvrir ce répertoire et afficher son contenuFEATURE

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.


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

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