What is the recommended treatment and dosage for erectile dysfunction (ED) using Vardenfil (Levitra)?

Vardenafil (Levitra) Treatment for Erectile Dysfunction

The recommended starting dose of vardenafil (Levitra) for most patients with erectile dysfunction is 10 mg taken orally approximately 60 minutes before sexual activity, with dose adjustments between 5-20 mg based on efficacy and side effects. 1

Dosing Guidelines

• For most patients, start with 10 mg taken approximately 60 minutes before sexual activity 1
• Maximum recommended dose is 20 mg 1
• Minimum dose is 5 mg 1
• Maximum recommended dosing frequency is once per day 1
• Can be taken with or without food 1
• Sexual stimulation is required for treatment response 1

Special Population Dosing Considerations

Age-Related Adjustments

• For patients ≥65 years of age, a starting dose of 5 mg is recommended 1

Hepatic Impairment

• Mild hepatic impairment (Child-Pugh A): No dose adjustment required 1
• Moderate hepatic impairment (Child-Pugh B): Starting dose of 5 mg recommended with maximum dose not exceeding 10 mg 1
• Severe hepatic impairment (Child-Pugh C): Not evaluated, use not recommended 1

Renal Impairment

• No dose adjustment required for mild (CLcr = 50-80 ml/min), moderate (CLcr = 30-50 ml/min), or severe (CLcr<30 ml/min) renal impairment 1
• Not evaluated in patients on renal dialysis 1

Drug Interactions

• For patients taking potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, clarithromycin):

  • Ritonavir: Single dose of 2.5 mg vardenafil should not be exceeded in a 72-hour period 1
  • Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: Single dose of 2.5 mg vardenafil should not be exceeded in a 24-hour period 1
  • Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: Single dose of 5 mg vardenafil should not be exceeded in a 24-hour period 1

• For patients taking alpha-blockers:

  • Start with 5 mg vardenafil if patient is stable on alpha-blocker therapy 1
  • Use 2.5 mg when used concomitantly with certain CYP3A4 inhibitors 1

Contraindications

• Concomitant use with nitrates is contraindicated due to risk of dangerous hypotension 2
• Patients with unstable or refractory angina should not receive treatment until cardiac condition has stabilized 2
• Patients with uncontrolled hypertension 2
• Patients with left ventricular dysfunction/CHF (NYHA class II or greater) 2
• Patients with MI or CVA within previous 2 weeks 2
• Patients with high-risk arrhythmias 2
• Patients with hypertrophic obstructive cardiomyopathies 2
• Patients with moderate-to-severe valvular disease 2

Efficacy

• Vardenafil significantly improves erectile function regardless of ED severity or etiology 3
• Vardenafil 10 or 20 mg showed significantly greater improvements in International Index of Erectile Function (IIEF) erectile function domain scores compared to placebo 4, 5
• Improvements in penetration and maintenance of erection were significantly greater with vardenafil 5-20 mg than with placebo 4, 5
• Vardenafil has similar efficacy to other PDE5 inhibitors (sildenafil, tadalafil, avanafil) in the general ED population 6
• Men with diabetes and post-prostatectomy patients have more severe ED at baseline and respond less robustly to PDE5 inhibitors including vardenafil 2, 6

Adverse Effects

• Most common adverse events are mild to moderate and transient 4, 5
• Most frequently reported adverse events include:
  • Headache 6, 5
  • Flushing 6, 5
  • Rhinitis 5, 7
  • Dyspepsia 6, 5
  • Sinusitis 5
• Myalgia has the lowest rates with vardenafil compared to other PDE5 inhibitors 6
• No reports of abnormal color vision at clinically recommended doses (5-20 mg) 4, 5

Optimizing Treatment Success

• Proper patient education is essential as incorrect use accounts for many treatment failures 2
• Explain that sexual stimulation is necessary 2
• More than one trial with the medication may be required to establish efficacy 2
• Dose should be titrated to provide optimal efficacy while minimizing adverse effects 2
• For patients who fail initial therapy, evaluate whether the trial was adequate before proceeding to alternative therapies 6

Special Considerations

• For men with testosterone deficiency who are considering ED treatment with vardenafil, combination with testosterone therapy may be more effective than vardenafil alone 2
• For men with predominantly psychogenic ED, vardenafil is still effective as first-line therapy 6