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DRUG INTERACTIONS

Effect of the Proton Pump Inhibitor Omeprazole on the Pharmacokinetics of Extended-Release Formulations of Oxybutynin and Tolterodine

Roger Dmochowski, Andrew Chen, Gayatri Sathyan, Scott MacDiarmid, Shalini Gidwani and Suneel Gupta

From the Department of Urology, Vanderbilt University School of Medicine, Nashville, Tennessee (R. Dmochowski); Ortho-McNeil Pharmaceutical, Inc, Raritan, New Jersey (A. Chen); ALZA Corporation, Department of Clinical Pharmacology, Mountain View, California (G. Sathyan, S. Gidwani, S. Gupta); and Wake Forest University School of Medicine, Department of Urology, Winston-Salem, North Carolina (S. MacDiarmid).

This study assessed the effect of the proton pump inhibitor omeprazole on the bioavailability of the extended-release formulations of oxybutynin and tolterodine. Forty-four healthy volunteers received each of 4 treatments in a 4-period crossover design. The treatments consisted of osmotically controlled extended-release oxybutynin chloride tablets at 10 mg/d or extended-release tolterodine tartrate capules at 4 mg/d, with and without preceding treatment with 20 mg omeprazole daily for 4 days. Blood samples collected predose and at scheduled time points for 36 hours postdose were analyzed for oxybutynin and its active metabolite, N-desethyloxybutynin, or tolterodine and its active 5-hydroxymethyl metabolite, as appropriate. The AUC{infty} ratios for oxybutynin and its metabolite with and without prior omeprazole fell within the 80% to 125% range (accepted as the criterion for bioequivalence), as did those for tolterodine and its active moiety. The peak concentration ratios for oxybutynin and metabolite also conformed to this range; those for tolterodine did not. Increasing gastric pH with omeprazole does not substantially alter the pharmacokinetic properties of extended-release oxybutynin but may alter those of extended-release tolterodine.

Key Words: Extended-release oxybutynin • extended-release tolterodine • omeprazole • pharmacokinetics • bioequivalence

Address for reprints: Roger Dmochowski, MD, Department of Urology, Vanderbilt University School of Medicine, Medical Center North, Room A1302, Nashville, TN 37232-2765.


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