Effect of multiple doses of montelukast, a cysLT(1) receptor antagonist, on digoxin pharmacokinetics in healthy volunteers

The effect of multiple oral doses of montelukast, a cysLT(1) receptor antag onist, on the pharmacokinetics of oral digoxin was studied in healthy male volunteers in a randomized double-blind two-period crossover study Subjects received 10 mg of montelukast or placebo daily for 11 days. On day 7, they received a single 0.5 mg oral dose of digoxin elixir. The pharmacokinetic parameters of digoxin (AUC(0-->24), AUC(0-->infinity), C-max, t(max), t(1/2 )) and cumulative urinary excretion over 120 hours were not affected by the multiple doses of montelukast. The 90% confidence interval for each of the se parameters fell within prespecified clinically acceptable bounds. Side e ffects were mild and transient. This suggests that concurrent administratio n of montelukast and digoxin was well tolerated. Concurrent treatment with montelukast has no effect on the pharmacokinetics of digoxin. Journal of Cl inical Pharmacology, 1999;39:941-944 (C) 1999 the American College of Clini cal Pharmacology.