Tadalafil Dosing for BPH Treatment
The recommended dose of tadalafil for the treatment of Benign Prostatic Hyperplasia (BPH) is 5 mg once daily, taken at approximately the same time each day. 1, 2
Evidence-Based Dosing Recommendation
The American Urological Association (AUA) guidelines provide a moderate recommendation (Evidence Level: Grade B) supporting the use of 5 mg daily tadalafil for patients with lower urinary tract symptoms (LUTS) associated with BPH, regardless of whether they have concurrent erectile dysfunction (ED). 1
This dosing recommendation is further supported by:
- FDA labeling that specifically states "The recommended dose of tadalafil tablets for once daily use for benign prostatic hyperplasia is 5 mg, taken at approximately the same time every day." 2
- Multiple randomized controlled trials demonstrating efficacy at this dose 3, 4, 5
Mechanism and Efficacy
Tadalafil, a phosphodiesterase-5 (PDE5) inhibitor, improves LUTS/BPH symptoms through mechanisms that are only partially understood. Clinical trials show:
- Significant improvement in International Prostate Symptom Score (IPSS) compared to placebo, with a mean change of -1.97 points (95% CI: -2.24 to -1.70) 3
- Improvements in both storage and voiding symptoms 3, 6
- Clinically meaningful improvement (defined as ≥3-point IPSS reduction) in approximately 69% of patients 5
- Rapid onset of action, with more than half of responders achieving clinically meaningful improvement after just 1 week of therapy 5
Important Clinical Considerations
Timing of Administration
- Tadalafil may be taken without regard to food 2
- Should be taken at approximately the same time each day 2
- Unlike tadalafil for ED, the once-daily dosing for BPH is not timed around sexual activity 2
Dose Adjustments
Renal impairment:
- For moderate renal impairment (CrCl 30-50 mL/min): Start with 2.5 mg daily; may increase to 5 mg based on individual response
- For severe renal impairment (CrCl <30 mL/min) or hemodialysis: Not recommended for once-daily use 2
Hepatic impairment:
- Mild to moderate impairment (Child-Pugh Class A or B): Use with caution
- Severe impairment (Child-Pugh Class C): Not recommended 2
Combination Therapy Considerations
- Important: Tadalafil should not be combined with alpha-blockers for LUTS/BPH as this combination offers no advantages in symptom improvement over either agent alone and may increase side effect risk 1
- When BPH therapy is initiated with tadalafil and finasteride, the recommended tadalafil dose remains 5 mg daily for up to 26 weeks 2
Safety Profile
- Generally well-tolerated with a favorable safety profile 3
- Common adverse events (≥2%) include increased erection, dyspepsia, back pain, headache, nasopharyngitis, and upper respiratory tract infection 4
- No significant changes in post-void residual volume have been observed with treatment 4
Patient Selection
Tadalafil is particularly beneficial for patients with concurrent BPH and ED, as it effectively treats both conditions simultaneously 6, 7. It may also provide additional cardiovascular benefits by improving endothelial function, as measured by brachial-ankle pulse wave velocity 7.
Monitoring
While not specifically required by guidelines, monitoring symptom improvement using validated tools like IPSS is reasonable to assess treatment response.