The pharmacokinetics of amlodipine was studied in 27 subjects with renal function ranging from normal to dialysis-dependent. Amlodipine (as a single 5-mg capsule) was administered once daily for 14 days and its plasma concentrations were measured by gas chromatography during and after treatment. Renal impairment had little or no effect on the pharmacokinetics of amlodipine. The elimination half-life was of the order of 50 h, similar to previously observed values, and did not vary with differences in renal function. Steady-state predose concentrations were observed after the ninth dose. Accumulation of amlodipine to steady-state levels was not significantly different from that expected on theoretical grounds and did not significantly change with renal function. These results suggest that once-daily administration of amlodipine is suitable for all degrees of renal function and that dosage adjustment is not necessary in renal impairment.

译文

在27名肾功能从正常到透析依赖的受试者中研究了氨氯地平的药代动力学。每天给药一次氨氯地平 (作为单个5 mg胶囊),持续14天,并在治疗期间和治疗后通过气相色谱法测量其血浆浓度。肾功能损害对氨氯地平的药代动力学几乎没有影响。消除半衰期约为50小时,与先前观察到的值相似,并且没有随肾功能的差异而变化。第9次给药后观察到稳态给药前浓度。氨氯地平积累到稳态水平与理论上的预期无显着差异,并且随肾功能无显着变化。这些结果表明,每天一次氨氯地平适用于所有程度的肾功能,并且在肾功能不全时无需调整剂量。

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