What is the highest recommended dose of tadalafil (Cialis) for erectile dysfunction?

Maximum Recommended Dose of Tadalafil

The maximum recommended dose of tadalafil for erectile dysfunction is 20 mg taken as needed, not to exceed once per day in most patients. 1

Dosing Guidelines for Erectile Dysfunction

• For as-needed use: The recommended starting dose is 10 mg taken prior to anticipated sexual activity, which may be increased to 20 mg or decreased to 5 mg based on individual efficacy and tolerability 1
• For once-daily use: The recommended starting dose is 2.5 mg taken at approximately the same time every day, which may be increased to 5 mg based on individual efficacy and tolerability 1
• Unlike sildenafil, tadalafil does not show a significant dose-response relationship between 5 mg, 10 mg, and 20 mg doses in terms of efficacy 2
• Tadalafil can be taken without regard to food and timing of sexual activity 1

Special Population Considerations

Renal Impairment

• Moderate renal impairment (creatinine clearance 30-50 mL/min):
  • For as-needed use: Starting dose of 5 mg not more than once per day, maximum dose 10 mg not more than once every 48 hours 1
  • For once-daily use: Starting dose of 2.5 mg, may increase to 5 mg based on individual response 1
• Severe renal impairment (creatinine clearance <30 mL/min or on hemodialysis):
  • For as-needed use: Maximum dose is 5 mg not more than once every 72 hours 1
  • Once-daily use is not recommended 1

Hepatic Impairment

• Mild to moderate impairment (Child-Pugh Class A or B):
  • For as-needed use: Should not exceed 10 mg once per day 1
  • Once-daily use has not been extensively evaluated; caution is advised 1
• Severe impairment (Child-Pugh Class C): Not recommended 1

Efficacy and Safety

• Tadalafil significantly improves erectile function compared to placebo, with approximately 69% of men reporting improved erections versus 33% with placebo 2
• The 17.5-hour half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, making it suitable for once-daily dosing 3
• In long-term studies, tadalafil 5 mg once daily was well tolerated and effective for up to 2 years 4
• Most common adverse effects include headache, flushing, dyspepsia, back pain, myalgia, and nasal congestion 1, 3

Clinical Considerations

• Tadalafil has a longer duration of action than other PDE5 inhibitors, with effects lasting up to 36 hours after dosing 1
• In a preference study, tadalafil 20 mg was preferred to sildenafil 50 mg for initiation of ED therapy 5
• For patients with both erectile dysfunction and benign prostatic hyperplasia (BPH), the recommended dose is 5 mg once daily 1
• Concomitant use with nitrates in any form is contraindicated due to risk of severe hypotension 1

Important Cautions

• When co-administered with alpha-blockers for ED, patients should be stable on alpha-blocker therapy prior to initiating tadalafil, and tadalafil should be initiated at the lowest recommended dose 1
• The combination of low-dose daily 5 mg tadalafil with alpha-blockers for BPH treatment offers no advantages in symptom improvement over either agent alone 2
• Patients should be advised that sexual activity carries a potential cardiac risk if they have cardiovascular disease 1