What is the recommended starting dose of vardenafil (Levitra) for erectile dysfunction?

Recommended Starting Dose of Vardenafil 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. 1

Dosing Guidelines

The FDA-approved dosing for vardenafil follows a clear algorithm:

• Standard starting dose: 10 mg
• Dose range: 5-20 mg based on efficacy and side effects
• Timing: Take approximately 60 minutes before sexual activity
• Maximum frequency: Once per day
• Food interactions: Can be taken with or without food 1

Special Population Considerations

Dose adjustments are required for certain patient populations:

Age-Related Adjustments

• Patients ≥65 years: Start with 5 mg 1

Hepatic Impairment

• Mild impairment (Child-Pugh A): No dose adjustment needed
• Moderate impairment (Child-Pugh B): Start with 5 mg; maximum dose 10 mg
• Severe impairment (Child-Pugh C): Not recommended 1

Renal Impairment

• Mild to severe renal impairment: No dose adjustment required
• Patients on dialysis: Not evaluated 1

Drug Interactions

• Potent CYP3A4 inhibitors (ritonavir, indinavir, saquinavir, atazanavir, ketoconazole 400mg daily, itraconazole 400mg daily, clarithromycin):

  • Single dose of 2.5 mg vardenafil should not be exceeded in a 24-hour period
  • For ritonavir: 2.5 mg not to be exceeded in a 72-hour period

• Moderate CYP3A4 inhibitors (erythromycin, ketoconazole 200mg daily, itraconazole 200mg daily):

  • Single dose of 5 mg vardenafil should not be exceeded in a 24-hour period 1

• Alpha-blockers: Start with 5 mg due to potential additive effects on blood pressure 1

Efficacy and Timing

Vardenafil is a potent and selective PDE5 inhibitor with demonstrated efficacy:

• Onset of action can be as early as 10 minutes after dosing 2
• Efficacy has been demonstrated for up to 8 hours after dosing 3
• Clinical trials show vardenafil significantly improves erectile function compared to placebo across various patient populations 4, 5

Important Clinical Considerations

The American Urological Association (AUA) guidelines emphasize several key points when prescribing PDE5 inhibitors:

1. Titration: Initial doses may need to be titrated up or down to find the optimal balance between efficacy and side effects 6

2. Patient education: Explain that:

   • Sexual stimulation is necessary for the medication to work
   • Multiple trials may be required to establish efficacy
   • Incorrect use (lack of sexual stimulation, taking with large meals) accounts for many treatment failures 6

3. Cardiovascular risk assessment: Evaluate cardiac risk factors before prescribing, as erectile dysfunction may be an early marker of cardiovascular disease 6

4. Contraindications: Do not use with nitrates due to risk of severe hypotension 6

Common Side Effects

The most frequently reported adverse events with vardenafil include:

• Headache
• Flushing
• Rhinitis
• Dyspepsia
• Sinusitis 4, 5

These side effects are typically mild to moderate in intensity and transient in nature.

By following these evidence-based dosing recommendations and considering patient-specific factors, vardenafil can be effectively and safely used as a first-line treatment for erectile dysfunction.