From the FDA Drug Label
Tadalafil tablets for Use as Needed Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours Tadalafil tablets for Once Daily Use Erectile Dysfunction Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended
The recommended dosing of tadalafil in patients with End-Stage Renal Disease (ESRD) is as follows:
- For use as needed: The maximum dose is 5 mg not more than once in every 72 hours.
- For once daily use: Tadalafil is not recommended due to increased exposure and limited clinical experience. 1 1
From the Research
For patients with end-stage renal disease (ESRD), Cialis (tadalafil) should be dosed at 5 mg twice weekly as the maximum dose, with consideration for starting at this dose based on the study by 2. This dosing is supported by a study published in 2017, which found that low-dose tadalafil (5 mg twice weekly) was effective in improving erectile function in patients with ESRD undergoing hemodialysis, with significant improvements in mean MSHQ scores and EHS scores 2. The study also found that tadalafil therapy was well-tolerated, with no significant difference in Beck's Depression Inventory scores and a significant decrease in Hamilton anxiety rate scores 2. It's essential to monitor patients for side effects, including headache, dyspepsia, back pain, and hypotension, and to note that nitrates remain absolutely contraindicated with tadalafil regardless of renal function, and caution should be exercised with alpha-blockers due to potential additive hypotensive effects. Other studies, such as 3 and 4, provide additional context on the prevalence and treatment of erectile dysfunction in patients with ESRD, but the study by 2 provides the most direct guidance on tadalafil dosing in this population. Additionally, a more recent study 4 estimated the overall pooled ED prevalence to be 71% in patients with ESRD, highlighting the importance of addressing this issue in clinical practice. However, the dosing recommendation is based on the highest quality and most recent study available, which is 2. Some studies, such as 5 and 6, provide general guidance on the management of patients with ESRD, but do not specifically address tadalafil dosing. In clinical practice, it's crucial to prioritize the patient's quality of life, morbidity, and mortality when making treatment decisions, and to consider the potential benefits and risks of tadalafil therapy in patients with ESRD. Key points to consider when prescribing tadalafil to patients with ESRD include:
- Starting with a dose of 5 mg twice weekly, as recommended by the study by 2
- Monitoring patients for side effects, including headache, dyspepsia, back pain, and hypotension
- Avoiding concomitant use of nitrates and exercising caution with alpha-blockers due to potential additive hypotensive effects
- Considering the patient's overall clinical status, including their renal function, comorbidities, and quality of life, when making treatment decisions.