What is the use of Tadalafil (Cialis) in patients with End-Stage Renal Disease (ESRD)?

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From the FDA Drug Label

  1. 7 Renal Impairment In clinical pharmacology studies using single-dose tadalafil (5 mg to 10 mg), tadalafil exposure (AUC) doubled in subjects with creatinine clearance 30 mL/min to 80 mL/min. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax and 2.7-to 4. 8-fold increase in AUC following single-dose administration of 10 mg or 20 mg tadalafil.
  • Tadalafil exposure increases in patients with end-stage renal disease (ESRD): In patients with ESRD on hemodialysis, tadalafil exposure (AUC) increases 2.7-to 4.8-fold.
  • Dose adjustment may be necessary: Although the label does not directly state the use of tadalafil in patients with ESRD, it provides information on increased exposure in these patients, which may require dose adjustment. Tadalafil can be used in patients with ESRD, but caution is advised due to increased exposure 1.

References

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