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Meloxicam pharmacokinetics in renal impairment
Author(s) -
BoultonJones J. M.,
Geddes C. G.,
Heinzel G.,
Türck D.,
Nehmiz G.,
Bevis P. J. R.
Publication year - 1997
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.1997.tb00135.x
Subject(s) - pharmacokinetics , meloxicam , medicine , pharmacology , metabolic clearance rate
Aims The aim of the present study was to determine how the pharmacokinetics of meloxicam are affected by kidney dysfunction and consequently to define the appropriate dose for the use of meloxicam in patients with mild or moderate renal impairment. Methods Meloxicam was administered to subjects with mild (creatinine clearance 41–60 ml min −1 ) to moderate (20–40 ml min −1 ) renal impairment compared with normal renal function (>60 ml min −1 ). Thirty‐eight subjects received meloxicam 15 mg once daily over 9 days. Meloxicam plasma concentrations were determined from blood samples taken during the study and pharmacokinetic parameters calculated according to noncompartmental methods. Results Subjects with no or mild renal impairment showed sinular pharmacokinetic profiles (geometric mean AUC SS (%gCV) 55 (33%) vs 55 (38%) μg ml −1 h). Subjects with moderate renal impairment demonstrated lower total plasma meloxicam concentrations (AUC SS 35 (50%) μg ml −1 h, with corresponding higher plasma clearance ( P = 0.013) compared with subjects with no renal impairment. However, this was combined with higher meloxicam free fractions in moderately impaired subjects such that free meloxicam concentrations were similar in all three groups. Meloxicam was well tolerated with few adverse events occurring and no difference in incidence observable between groups. Conclusions On the basis of these results there is no necessity for a dosage adjustment when administering meloxicam to patients with mild to moderate renal impairment.