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.
Hospital Saint-Antoine, Paris, France.
F
F
Darnis
R
R
Poupon
D000328:Adult; D017311:Amlodipine / Q000009:adverse effects* / Q000493:pharmacokinetics*; D005260:Female; D006207:Half-Life; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D017093:Liver Failure / Q000378:metabolism* / Q000503:physiopathology; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged
D017311:Amlodipine