Dose individualisation in patients with renal insufficiency: does drug labelling support optimal management?

Eur J Clin Pharmacol. 2005 Jan;60(11):807-11. doi: 10.1007/s00228-004-0852-y. Epub 2004 Dec 14.


Objective: An important information source for pharmacotherapy in populations at risk is drug labelling. We compared the recommendations for patients with renal insufficiency included in German drug labellings with evidence from the literature.

Methods: From the 120 drugs with the highest turnover in a large university hospital, all drugs with pharmacokinetics independent of renal function (n=48) and those with substantial accumulation in renal failure (n=28) were identified. For both groups of compounds, pharmacokinetic and pharmacodynamic aspects relevant for dose individualisation in those with renal insufficiency were extracted from the literature and compared with the information given in the German drug labelling.

Results: Over half of the labellings (15 of 26) of non-accumulating drugs without renal adverse drug reactions contained no dose recommendation for patients with renal insufficiency. The labelling of nephrotoxic compounds that do not accumulate included more frequently a recommendation to adapt the dose or to monitor than the labelling of drugs without nephrotoxic potential (15 of 22 versus 5 of 26, P=0.002). For over half of accumulating drugs (16 of 28), the dose given in the labelling depends primarily on creatinine clearance. The ratio between the labelling dose and the dose based on the pharmacokinetic concept to achieve identical plasma concentrations (Q0 concept) differed widely (0.4-2).

Conclusions: When renal failure had no impact on dosing, information was often missing. Such information is however important to differentiate, whether no dose adaptation is necessary or no information is available. If dose adjustment is required, application of a uniform concept is desirable.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Creatinine / metabolism
  • Dose-Response Relationship, Drug
  • Drug Labeling*
  • Drug-Related Side Effects and Adverse Reactions
  • Germany
  • Humans
  • Pharmaceutical Preparations* / administration & dosage
  • Pharmaceutical Preparations* / standards
  • Pharmacokinetics*
  • Renal Insufficiency / metabolism*


  • Pharmaceutical Preparations
  • Creatinine