What is the maximum recommended dose of udenafil (phosphodiesterase type 5 inhibitor)?

Maximum Recommended Dose of Udenafil

The maximum recommended dose of udenafil is 100 mg taken as needed for erectile dysfunction, with no established maximum daily dose for chronic use. 1, 2

Dosing Information

• Udenafil is a phosphodiesterase type 5 inhibitor (PDE5i) used for the treatment of erectile dysfunction 3
• Standard dosing ranges:
  • Starting dose: 100 mg taken as needed 1, 4
  • Maximum single dose: 100 mg 1, 4
  • For once-daily dosing regimens: 25-75 mg daily, with 50-75 mg showing significant efficacy 4, 5

Pharmacokinetic Properties

• Rapid absorption with peak plasma concentrations reached within 0.8-1.3 hours after administration 2
• Terminal half-life of 7.3-12.1 hours, allowing for both on-demand and once-daily dosing options 2, 5
• Area under the curve (AUC) and maximum plasma concentrations (Cmax) increase supraproportionally with increasing doses 2
• Steady state is reached after approximately 5 days of daily dosing 2

Efficacy Considerations

• Udenafil at 100 mg has demonstrated effectiveness for up to 12 hours after dosing, providing flexibility for sexual activity 1
• Once-daily dosing at 50-75 mg has shown significant improvement in erectile function over a 12-week treatment period 4
• Similar to other PDE5 inhibitors, udenafil improves erections and successful sexual intercourse rates compared to placebo 3, 1

Safety and Adverse Effects

• Most common adverse events include:
  • Flushing (most common) 4
  • Headache 3
  • Nasal congestion 3
  • Dyspepsia 3
• Adverse events are generally mild to moderate in severity and transient 1, 2
• No significant drug accumulation has been observed with multiple administrations 2

Important Contraindications and Precautions

• PDE5 inhibitors should not be used concomitantly with nitrate medications due to risk of severe hypotension 3
• For patients on sildenafil or vardenafil, nitrates should be avoided for at least 24 hours; for tadalafil, at least 48 hours 3
• Use with caution in patients with mild to moderate hepatic or renal impairment, initially at lower doses 3
• Generally not recommended in patients with severe renal or liver disease 3

Dosing in Special Populations

• Lower doses may be appropriate for:
  • Elderly patients 6
  • Patients with hepatic or renal impairment 3, 6
  • Patients taking CYP3A4 inhibitors 6

Optimizing Treatment Success

• Sexual stimulation is necessary for the medication to be effective 3
• Multiple trials may be required to establish efficacy 3
• Dose titration may be necessary to find the optimal balance between efficacy and side effects 3