randomized double-blind two-way crossover study. The primary endpoint, Cmin"8, was within the accepted range for bioequivalence, as were Cmaxss and AUCSS. The 90% confidence interval and the point estimator of 98.7 for Cminss were within the equivalence range of 0.8-1.25. MRT and tmax were also unchanged, while the elimination rate constant was decreased slightly by 12%, which is of no therapeutic relevance. It is concluded that co-treatment with meloxicam has no effect on the pharmacokinetics of oral digoxin.
Keywords meloxicam 0-acetyl-digoxin pharmacokinetic interactionIntroduction treatment phases of 8 days each and a washout period of 14 days. Either meloxicam 15 mg or placebo was Digoxin is often used in the treatment of cardiac disease administered once daily on days 1-8 of treatment. in rheumatic patients concomitantly receiving non-P-acetyl-digoxin was administered on days 1-7, in steroidal anti-inflammatory drugs (NSAIDs). Some divided doses of 0.4 mg, 0.3 mg and 0.3 mg on day 1; NSAIDs are known to influence digoxin pharmaco-0.2 mg, 0.2 mg and 0.1 mg on day 2 and 0.3 mg oncekinetics [1, 2]. More recently developed NSAIDs like daily on days 3-7. The drugs were administered within nimesulide or lornoxicam failed to show a major 10 min after meals. The dosing interval on days 1 and 2 interaction with digoxin [3,4], the latter produced a was 8 h. modest reduction in digoxin clearance [4].Blood samples for determination of plasma digoxin The objective of this study was to determine any concentration were taken on day 7 at 0, 15, 30, 45, 60,