Pharmacokinetics and safety of single oral doses of amlodipine in patients with and without hepatic impairment: an open study.

An open study was conducted to assess the pharmacokinetics, cardiovascular effects and safety of a single oral dose of amlodipine 5 mg in 12 patients with hepatic impairment and eight healthy convalescing subjects. Cmax values were found to be similar in both groups although Tmax was shorter, and T1/2 was longer, in patients with hepatic insufficiency. AUCs were also higher in hepatic patients although these differences were not significantly different. No side-effects or cardiovascular/ECG changes were observed in either group. Three patients with hepatic failure experienced mild laboratory abnormalities which were of doubtful clinical significance.