What is the recommended dosing regimen for Cialis (tadalafil) in patients with Benign Prostatic Hyperplasia (BPH)?

Tadalafil Dosing for Benign Prostatic Hyperplasia

For BPH treatment, tadalafil should be initiated at 5 mg once daily, taken at approximately the same time each day, with no titration required—this is a fixed dose, not a titration regimen. 1

Standard Dosing Regimen

• The FDA-approved dose for BPH is tadalafil 5 mg once daily, which is the only recommended dose for this indication 1
• No dose titration is performed for BPH—unlike erectile dysfunction where doses can be adjusted between 2.5-5 mg for daily use, BPH treatment uses a fixed 5 mg dose 1
• The medication should be taken at approximately the same time every day, without regard to timing of sexual activity or food intake 1

Combination Therapy Considerations

• When initiating therapy for BPH with both tadalafil and finasteride, the recommended dose remains 5 mg once daily for up to 26 weeks 1
• Tadalafil 5 mg should NOT be combined with alpha-blockers for BPH treatment, as the 2021 AUA guidelines explicitly state this combination offers no advantages in symptom improvement over either agent alone 2
• If a patient is already on alpha-blocker therapy and tadalafil is being added for erectile dysfunction (not BPH), the patient must be stable on alpha-blocker therapy first, and tadalafil should be initiated at the lowest dose 1

Efficacy Expectations

• Tadalafil 5 mg produces modest symptom improvement, with a mean IPSS reduction of approximately -1.74 points compared to placebo (tadalafil: -5.4 points vs placebo: -3.6 points) 2
• The percentage of treatment responders (defined as ≥3 point IPSS change) shows relative effects of 1.13 to 1.80, suggesting tadalafil probably increases response rates compared to placebo 2
• Tadalafil is most appropriate for men with concomitant erectile dysfunction, as it can address both conditions simultaneously 2
• The medication does not significantly improve maximum urinary flow rate (Qmax) or post-void residual volume in most patients 3, 4

Dose Adjustments for Special Populations

Renal Impairment

• Creatinine clearance 30-50 mL/min: Start with 2.5 mg once daily for BPH; may increase to 5 mg based on individual response 1
• Creatinine clearance <30 mL/min or hemodialysis: Tadalafil for once-daily use is NOT recommended for BPH 1

Hepatic Impairment

• Mild to moderate hepatic impairment (Child-Pugh Class A or B): Use with caution, as once-daily tadalafil has not been extensively evaluated in this population 1
• Severe hepatic impairment (Child-Pugh Class C): Tadalafil is NOT recommended 1

Clinical Context and Positioning

• Tadalafil represents a treatment option primarily for men who desire treatment of both BPH/LUTS and erectile dysfunction 2
• The 2021 AUA guidelines provide a moderate recommendation (Evidence Level Grade B) for discussing tadalafil 5 mg daily as a treatment option for patients with LUTS/BPH irrespective of comorbid ED 2
• Alpha-blockers remain first-line therapy for BPH, producing superior symptom relief (4-6 point IPSS improvement) compared to tadalafil 5
• The 2023 European Association of Urology guidelines support tadalafil 5 mg once daily for improving LUTS and erectile dysfunction based on systematic reviews and meta-analyses 2

Safety Profile

• Common adverse effects include facial flushing (most common), headache, and dizziness, typically mild to moderate in intensity 6, 4
• Tadalafil does not cause significant hypotensive events when used alone for BPH 6
• The medication avoids sexual adverse events associated with alpha-blockers (ejaculatory dysfunction) and 5-alpha-reductase inhibitors (erectile dysfunction, decreased libido) 3
• Tablets should not be split; the entire dose must be taken 1

Important Caveats

• There is no titration protocol for BPH—clinicians should not attempt to adjust the dose as they might for erectile dysfunction 1
• The modest efficacy compared to alpha-blockers means tadalafil should be reserved for specific clinical scenarios rather than used as routine first-line therapy 2
• Patients planning cataract surgery should be counseled about intraoperative floppy iris syndrome risk with alpha-blockers, making tadalafil a potential alternative in this population 5