Abstract
This open study evaluated the influence of renal function on the pharmacokinetics of ranitidine (50 mg iv infusion given over 6 min). Five groups, each of 8 subjects, 1 with normal renal function and 4 with different degrees of renal impairment were studied.
Renal function was assessed in each patient by 51Cr-EDTA (glomerular filtration rate, GFR), creatinine clearance (GFR) and N-methylnicotinamide clearance (reflecting glomerular and tubular function). Sixteen blood samples (5 ml) taken up to 48 h post dose from each subject were analysed for plasma ranitidine concentrations by reversed phase HPLC.
Patient groups with renal impairment had significantly increased AUC∞ and t1/2 with corresponding decreases in CLp and λz when compared with normal subjects. There was also a significant increase in tmax but not in Cmax. There was a high linear correlation between the degree of renal impairment and ranitidine clearance.
In patients with GFR ≤ 20 ml min−1, the AUC∞ mean ratio (compared with normal subjects) was up to 4.6 while for patients with GFR 20–50 ml min−1, the average AUC∞ ratio was 2.6. It is recommended that the dose of ranitidine is halved in patients with GFR ≤ 20 ml min−1.
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Dixon, J.S., Borg-Costanzi, J.M., Langley, S.J. et al. The effect of renal function on the pharmacokinetics of ranitidine. Eur J Clin Pharmacol 46, 167–171 (1994). https://doi.org/10.1007/BF00199883
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DOI: https://doi.org/10.1007/BF00199883