Müller F O, Schall R, de Vaal A C, Groenewoud G, Hundt H K, Middle M V
FARMOVS Institute for Clinical Pharmacology and Drug Development, Department of Pharmacology, University of the Orange Free State, Republic of South Africa.
Eur J Clin Pharmacol. 1995;48(3-4):247-51. doi: 10.1007/BF00198306.
Fifteen healthy male volunteers participated in an open, multiple-dose study to investigate a possible interaction between furosemide and meloxicam, a new non-steroidal anti-inflammatory agent (NSAID). The study comprised three treatment periods. First, furosemide (40 mg) was administered as a single oral daily dose for 3 days. A wash-out day was followed by the administration of meloxicam (15 mg) as a single oral daily dose for 10 days. Thereafter, meloxicam and furosemide were administered concomitantly at the same doses as described above, for 3 days. The effect of concomitant ingestion of meloxicam and furosemide on furosemide-induced diuresis, urine and serum electrolytes, and furosemide pharmacokinetics was determined, after both single and repeated administration of furosemide. Estimates of the "(furosemide+meloxicam)/(furosemide alone)" mean ratio of the variable AUC(0-infinity) for plasma furosemide and the cumulative sodium excretion (0-8 h) were 97.4% (90% confidence interval 89.7-106%) and 88% (90% confidence interval 82-94%), respectively. The study results indicate that meloxicam does not affect the pharmacokinetics of furosemide in healthy volunteers, nor does it affect furosemide-induced diuresis or serum electrolytes. The cumulative urinary electrolyte excretion after concomitant administration of meloxicam and furosemide is somewhat lower than after administration of furosemide alone, in particular for the period 0-8 h after administration of furosemide. This effect of meloxicam on furosemide dynamics is small, and is probably not clinically relevant in healthy volunteers under the dosing regime studied.
15名健康男性志愿者参与了一项开放性多剂量研究,以调查速尿与一种新型非甾体抗炎药(NSAID)美洛昔康之间可能存在的相互作用。该研究包括三个治疗阶段。首先,速尿(40毫克)以每日单次口服剂量给药3天。经过1天的洗脱期后,美洛昔康(15毫克)以每日单次口服剂量给药10天。此后,美洛昔康和速尿以上述相同剂量同时给药3天。在速尿单次和重复给药后,测定了美洛昔康和速尿同时摄入对速尿诱导的利尿、尿液和血清电解质以及速尿药代动力学的影响。血浆速尿的可变AUC(0至无穷大)以及累积钠排泄量(0至8小时)的“(速尿+美洛昔康)/(单独使用速尿)”平均比值估计分别为97.4%(90%置信区间89.7 - 106%)和88%(90%置信区间82 - 94%)。研究结果表明,美洛昔康不影响健康志愿者中速尿的药代动力学,也不影响速尿诱导的利尿或血清电解质。美洛昔康和速尿同时给药后的累积尿电解质排泄量略低于单独使用速尿后的排泄量,特别是在速尿给药后0至8小时期间。美洛昔康对速尿动力学的这种影响较小,在所研究的给药方案下,对健康志愿者可能不具有临床相关性。