Summary
25 hypertensive patients with normal or impaired renal function underwent pharmacokinetic and safety studies after single and multiple dose administration of nifedipine GITS (Gastro-Intestinal Therapeutic System) 60mg tablets. Complete pharmacokinetic data were obtained from 23 of these patients. Blood pressure and heart rate changes were compatible with the known properties of the drug. Impaired renal function did not affect the maximum plasma concentrations or bioavailability of nifedipine after single or multiple dose administration of nifedipine GITS, nor was there any evidence of excessive drug accumulation in the presence of renal impairment.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Challenor VF, Waller DG, Renwick AG, et al. The trans-hepatic extraction of nifedipine. Br J Clin Pharmacol 1987; 24: 473–7.
Guengerich FP. Oxidate cleavage of carboxylic esters by cytochrome P-450. J Biol Chem 1987; 262: 8459–62.
Guengerich FP, Bocker RH. Cytochrome P-450-catalyzed dehydrogenation of 1,4-dihydropyridines. J Biol Chem 1988; 263: 8168–75.
Cederlof IO, Anderson P, Bondesson U. Nifedipine as an anti-hypertensive drug in patients with renal failure — pharmacokinetics and effects. J Intern Med 1990; 227: 329–37.
Crome P, Muller FO, Wijayawardhana P, et al. Single dose and steady-state pharmacokinetic profiles of nifedipine GITS tablets in healthy and elderly and young volunteers. Drug Invest 1993; 5: 193–9.
Doyle GD, Donohue J, Carmody M, et al. Pharmacokinetics of amlodipine in renal impairment. Eur J Clin Pharmacol 1989; 36: 205–8.
Kleinbloesem CH, van Brummelen P, van Harten J, et al. Nifedipine: influence of renal function in pharmacokinetic/pharmacodynamic relationship. Clin Pharmacol Ther 1985; 37: 563–74.
Rahn KH, van Bortel LM, Mooy JM. The use of calcium antagonists in patients with renal failure. J Hypertens 1987; 5 Suppl. 4: S67–9.
Ramsch KD, Graefe KH, Scherling D, et al. Pharmacokinetics and metabolism of calcium-blocking agents nifedipine, nitrendipine and nimodipine. Am J Nephrol 1986; 6: 73–80.
van Bortel L, Bohm R, Mooij J, et al. Total and free steady-state plasma levels and pharmacokinetics of nifedipine in patients with terminal renal failure. European Journal of Clinical Pharmacology 1989; 37: 185–9.
Iaina A, Schneider R, Stolero D, et al. Pharmacokinetics and safety of nifedipine coat core, once daily tablets in chronic renal failure. In: Andreucci & Dal Canton, editors. Current therapy in nephrology, Milan: Wichtig Editore, 1993: 127–31.
Foster TS, Hamann SR, Richards VR, et al. Nifedipine kinetics and bioavailability after single intravenous and oral doses in normal subjects. J Clin Pharmacol 1983; 23: 161–70.
Reiberg DP, Love SJ, Quercia GT, et al. Effect of food on nifedipine pharmacokinetics. Clin Pharmacol Ther 1987; 42: 72–5.
Renwick AG, LeVie J, Challenor VF, et al. Factors affecting the pharmacokinetics of nifedipine. Eur J Clin Pharmacol 1987; 32: 351–5.
Debbas NMG, Jackson SHD, Shah K, et al. The bioavailability and pharmacokinetics of slow release nifedipine during chronic dosing in volunteers. Br J Clin Pharmacol 1986; 21: 385–8.
Donnelly R, Elliot HL, Meredith PA, et al. Individual responses and concentration-effect relationships. Hypertension 1988; 12: 443–9.
Taburet AM, Singlas E, Colin JN, et al. Pharmacokinetics studies of nifedipine tablet. Correlation with antihypertensive effects Hypertension 1983; 5: II29–II33.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Schneider, R., Stolero, D., Griffel, L. et al. Pharmacokinetic Profile of Nifedipine GITS in Hypertensive Patients with Chronic Renal Impairment. Drugs 48 (Suppl 1), 16–22 (1994). https://doi.org/10.2165/00003495-199400481-00006
Published:
Issue Date:
DOI: https://doi.org/10.2165/00003495-199400481-00006