Maximum Dose of Avanafil
The maximum dose of avanafil that has been tried and is FDA-approved is 200 mg, taken as early as approximately 15 minutes before sexual activity. 1
FDA-Approved Dosing
- The FDA label specifies that avanafil is available in 50 mg, 100 mg, and 200 mg tablets, with 200 mg being the highest approved dose 1
- The recommended starting dose is 100 mg, which can be increased to 200 mg or decreased to 50 mg based on individual efficacy and tolerability 1
- Maximum dosing frequency is once per day 1
Clinical Trial Evidence
- Clinical trials evaluated avanafil at doses of 50 mg, 100 mg, and 200 mg in over 1,300 patients, including those with diabetes mellitus and post-radical prostatectomy 2, 3
- The 200 mg dose demonstrated significantly greater efficacy than the 50 mg dose in improving erectile function domain scores and successful intercourse attempts 2
- A recent case series showed significant improvement in IIEF-5 scores with 200 mg avanafil (from 14.83±9.4 to 24.17±2.6, P<0.05) in patients with comorbidities 4
Efficacy at Maximum Dose
- Both 100 mg and 200 mg doses were significantly more effective than placebo across all primary endpoints in randomized controlled trials 2, 5
- Approximately two-thirds of sexual intercourse attempts made within 15 minutes or more than 6 hours after 200 mg administration were successful, compared to one-quarter with placebo 2
- Meta-analysis confirmed that avanafil 200 mg is effective and well-tolerated for erectile dysfunction 6
Safety Profile at 200 mg
- Extended treatment with avanafil for >52 weeks showed only 2.8% of patients discontinued due to adverse reactions, with no drug-related serious adverse events 2
- The most common adverse effects at 200 mg include headache (more likely than with 100 mg), flushing, nasal congestion, and dyspepsia 5, 6
- No adverse events were reported in a recent case series using 200 mg in patients with multiple comorbidities 4
Important Dosing Restrictions
- Do not use avanafil with strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin, etc.) 1
- With moderate CYP3A4 inhibitors (erythromycin, diltiazem, fluconazole), maximum dose is 50 mg, not to exceed once every 24 hours 1
- When co-administered with alpha-blockers, start at 50 mg after patients are stable on alpha-blocker therapy 1
Critical Safety Consideration
- In patients who have taken avanafil, at least 12 hours should elapse before nitrate administration in life-threatening emergencies, and only under close medical supervision 1