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Coadministration of Lansoprazole and Naproxen Does Not Affect the Pharmacokinetic Profile of Methotrexate in Adult Patients With Rheumatoid Arthritis

From TAP Pharmaceuticals Products, Inc, Lake Forest, Illinois.

Drugs prescribed for rheumatoid arthritis are often associated with gastrointestinal toxicity, and proton pump inhibitors may be coadministered for gastroprotection. In this open-label study, the effect of lansoprazole 30 mg qd and naproxen 500 mg bid on the pharmacokinetic profile of methotrexate was investigated. Twenty-seven adult rheumatoid arthritis patients on stable oral methotrexate doses (7.5-15 mg/week) for a minimum of 3 months were enrolled. Methotrexate pharmacokinetics were assessed on days –1 (methotrexate alone) and 7 (methotrexate with lansoprazole and naproxen). Pharmacokinetics of methotrexate and 7-hydroxymethotrexate were not altered by coadministration of methotrexate with lansoprazole and naproxen; point estimates and 90% confidence intervals for the peak plasma concentration and area under the plasma concentration-time curveof methotrexate and 7-hydroxymethotrexate were within the 0.80 to 1.25 boundaries. Therefore, coadministration of naproxen and lansoprazole for 7 days does not affect the pharmacokinetic profile of low doses of methotrexate.

Key Words: Lansoprazole • methotrexate • 7-hydroxymethotrexate • naproxen • interaction • pharmacokinetics • renal clearance • rheumatoid arthritis

Address for reprints: Majid Vakily, PhD, TAP Pharmaceutical Products, Inc, Department of Drug Metabolism & Pharmacokinetics, 675 North Field Drive, Lake Forest, IL 60045; e-mail: majid.vakily{at}tap.com.

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