What is the recommended dosage and usage of Tadalafil (tadalafil) for erectile dysfunction and benign prostatic hyperplasia (BPH)?

Tadalafil Dosing Recommendations for Erectile Dysfunction and BPH

For erectile dysfunction, tadalafil can be prescribed as either 10 mg as needed (which may be adjusted to 5-20 mg based on efficacy and tolerability) or 5 mg once daily; for benign prostatic hyperplasia, the recommended dose is 5 mg once daily. 1

Erectile Dysfunction (ED) Dosing Options

As-Needed Dosing

• The recommended starting dose is 10 mg taken prior to anticipated sexual activity 1
• The dose may be increased to 20 mg or decreased to 5 mg based on individual response and tolerability 1
• Maximum recommended dosing frequency is once per day 1
• Tadalafil improves erectile function compared to placebo for up to 36 hours following dosing 1
• Approximately 69% of men report improved erections with tadalafil versus 33% with placebo 2

Once-Daily Dosing

• The recommended starting dose is 2.5 mg taken at approximately the same time every day 1
• May be increased to 5 mg based on individual efficacy and tolerability 1
• Once-daily dosing provides an alternative for couples who prefer spontaneous rather than scheduled sexual activity 2
• Daily dosing has been shown to significantly improve erectile function compared to placebo in clinical trials 3

Benign Prostatic Hyperplasia (BPH) Dosing

• The recommended dose is 5 mg once daily, taken at approximately the same time every day 1
• This dosage is endorsed by the American Urological Association for BPH treatment 2
• Tadalafil 5 mg daily significantly improves International Prostate Symptom Score (IPSS) compared to placebo 4
• When initiating therapy for BPH with tadalafil and finasteride, the recommended dose is 5 mg once daily for up to 26 weeks 1

Combined ED and BPH Treatment

• For patients with both ED and BPH, the recommended dose is 5 mg once daily 1
• This single dosage effectively treats both conditions simultaneously 4
• Tadalafil 5 mg significantly improved both ED and BPH-related outcomes in clinical trials 4

Special Dosing Considerations

Renal Impairment

• For as-needed use in patients with creatinine clearance 30-50 mL/min: 5 mg maximum once per day 1
• For as-needed use in patients with creatinine clearance <30 mL/min: 5 mg maximum once every 72 hours 1
• For once-daily use in patients with creatinine clearance <30 mL/min: not recommended 1
• For once-daily BPH treatment in patients with creatinine clearance 30-50 mL/min: start with 2.5 mg, may increase to 5 mg based on response 1

Hepatic Impairment

• Mild to moderate impairment (Child-Pugh Class A or B): For as-needed use, dose should not exceed 10 mg once per day 1
• Severe impairment (Child-Pugh Class C): Tadalafil use is not recommended 1

Concomitant Medications

• Nitrates: Concomitant use in any form is contraindicated 1
• Alpha-blockers: Patients should be stable on alpha-blocker therapy before initiating tadalafil, which should be started at the lowest recommended dose 1
• Clinicians should not offer the combination of daily tadalafil 5 mg with alpha-blockers for BPH treatment as it offers no advantages in symptom improvement over either agent alone 2

Common Side Effects

• Most common adverse effects include headache, flushing, rhinitis, and dyspepsia 2
• In clinical trials, tadalafil was generally well tolerated with adverse events typically being mild to moderate in intensity 5

Practical Considerations

• Tadalafil may be taken without regard to food 1
• Do not split tadalafil tablets; the entire dose should be taken 1
• Unlike the dose-response relationship observed with sildenafil, tadalafil does not show significant additional efficacy at higher doses (20 mg vs. 10 mg vs. 5 mg) 6, 2