Influence of manufacturer lot number on pharmacokinetic manipulation of gentamicin serum concentrations.
A prospective, randomized trial was performed to study the impact of lot variation on pharmacokinetic manipulation of serum gentamicin concentrations. Twenty patients receiving gentamicin were randomized prospectively into two groups. Group I patients had blood samples obtained before and after two doses during their hospital regimen using gentamicin from the same lot number. Group II patients had the samples obtained around two doses using different lot numbers of gentamicin. Pharmacokinetic parameters were calculated assuming a one-compartment model and were compared between the initial and subsequent set of serum concentrations. For Group I, the gentamicin distribution volume (Vd) did not differ (mean change, -0.007 L/kg, or mean absolute percentage change, 20.8%). Group II also did not have a significant mean change in Vd (0.023 L/kg, or mean absolute percentage change, 18.7%). The gentamicin Vd did not appear to change over time whether gentamicin was administered using identical or differing lot numbers.
D000328:Adult; D001682:Biological Availability; D004345:Drug Industry; D005260:Female; D005839:Gentamicins / Q000097:blood / Q000592:standards*; D006801:Humans; D007700:Kinetics; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011897:Random Allocation
D005839:Gentamicins