What to do for a patient on tadalafil (Cialis) 5 mg with erectile dysfunction and no urinary symptoms?

Increase Tadalafil Dose to Optimize Erectile Function

For a patient on tadalafil 5 mg daily with persistent erectile dysfunction and no urinary symptoms, increase the dose to the maximum of 20 mg as needed or switch to 5 mg daily if not already on that regimen, as the current dose is suboptimal for treating ED alone. 1

Dosing Strategy for Erectile Dysfunction

The FDA-approved dosing for tadalafil specifically for ED differs significantly from BPH treatment 1:

• As-needed dosing: Start at 10 mg, with titration up to 20 mg or down to 5 mg based on efficacy and tolerability 1
• Daily dosing for ED: Start at 2.5 mg daily, with increase to 5 mg daily based on response 1
• The current 5 mg daily dose is FDA-approved primarily for BPH or combined ED/BPH, not ED alone 1

Why Current Dosing May Be Inadequate

Your patient is receiving a dose designed for urinary symptoms, not optimized for erectile function 2:

• Tadalafil 5 mg daily was studied and approved for men with both ED and LUTS/BPH, not ED in isolation 3, 4
• The AUA guideline specifically states tadalafil 5 mg daily "should be discussed as a treatment option" for patients with LUTS/BPH "irrespective of comorbid erectile dysfunction," indicating this dose targets urinary symptoms primarily 2
• Studies show once-daily 5 mg improves ED, but as-needed 20 mg provides superior erectile function improvement in head-to-head comparisons 4

Recommended Management Algorithm

Step 1: Verify adequate trial duration

• Ensure the patient has attempted at least 5 separate sexual encounters at the current dose before declaring treatment failure 5
• Confirm sexual stimulation is occurring, as this is necessary for tadalafil efficacy 5

Step 2: Optimize dosing for ED

• Switch to as-needed 20 mg taken prior to anticipated sexual activity (effective up to 36 hours) 1
• Alternative: Continue 5 mg daily if patient prefers spontaneous sexual activity without timing medication 5
• Maximum frequency for as-needed dosing is once per day 1

Step 3: Titrate and assess response

• The AUA recommends titrating doses to find optimal balance between efficacy and side effects 5
• Unlike sildenafil and vardenafil, tadalafil efficacy is not strictly dose-dependent between 5-20 mg, but higher doses do benefit some patients 5

Step 4: Consider adjunctive therapy if inadequate response

• Check testosterone level; if deficient, combining tadalafil with testosterone therapy may be more effective than tadalafil alone 5
• Testosterone alone is not effective monotherapy for ED 5

Critical Safety Considerations

Before dose escalation, verify 5, 1:

• No nitrate use (any form) - absolute contraindication due to potentially fatal hypotension 5
• Cardiovascular risk assessment - patient should be able to perform moderate physical activity; refer to cardiology if unable 5
• Renal function - if creatinine clearance 30-50 mL/min, maximum dose is 10 mg every 48 hours; if <30 mL/min, maximum is 5 mg every 72 hours 1
• Hepatic function - if moderate impairment (Child-Pugh A or B), maximum dose is 10 mg; severe impairment (Child-Pugh C) is contraindicated 1

Common Pitfalls to Avoid

• Don't continue suboptimal dosing - the 5 mg daily dose without urinary symptoms suggests the wrong indication is being treated 2, 1
• Don't combine with alpha-blockers - the AUA specifically recommends against combining tadalafil 5 mg daily with alpha-blockers for LUTS/BPH as it offers no advantage 2
• Don't assume treatment failure prematurely - inadequate dosing accounts for a large percentage of perceived PDE5 inhibitor failures 5
• Don't forget to counsel on timing - patients must understand sexual stimulation is required and that as-needed dosing works up to 36 hours 1

Expected Outcomes

With proper dosing optimization 5, 3:

• High-quality evidence shows 69% of men using tadalafil as-needed report successful intercourse attempts versus 33% with placebo 5
• Daily 5 mg tadalafil significantly improved erectile function in studies, but primarily in populations with concurrent LUTS 3, 4
• Most common adverse events include headache, dyspepsia, back pain, nasal congestion, and myalgia 5