What is the recommended starting dose of Vardenafil (Levitra) for patients?

Recommended Starting Dose of Vardenafil

The recommended starting dose of vardenafil (Levitra) for most patients is 10 mg taken orally approximately 60 minutes before sexual activity. 1

Dosing Guidelines

The FDA-approved dosing for vardenafil follows a specific pattern based on patient characteristics:

• Standard starting dose: 10 mg taken approximately 60 minutes before sexual activity 1
• Dose adjustment range: 5-20 mg based on efficacy and side effects 1
• Maximum frequency: Once per day 1
• Administration: Can be taken with or without food 1
• Important note: Sexual stimulation is required for treatment response 1

Special Population Considerations

Age-Related Adjustments

• Patients ≥65 years: Starting dose of 5 mg is recommended 1

Hepatic Impairment

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

Renal Impairment

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

Drug Interaction Considerations

Concomitant Medications Requiring Dose Adjustment

• Potent CYP3A4 inhibitors (ritonavir, 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 (72-hour period for ritonavir) 1

• Moderate CYP3A4 inhibitors (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

• Alpha-blockers:

  • Starting dose of 5 mg is recommended 1
  • Initiate only if patient is stable on alpha-blocker therapy 1

Important Safety Considerations

Contraindications

• Nitrate medications: Phosphodiesterase type 5 inhibitors should not be used concomitantly with nitrate medications due to risk for severe hypotension 2
• Timing considerations: Patients on sildenafil or vardenafil should avoid taking nitroglycerin for at least 24 hours (48 hours for tadalafil) 2

Efficacy Profile

Vardenafil has demonstrated significant efficacy in clinical trials:

• Approximately 68% successful sexual intercourse attempts with vardenafil versus 35% with placebo 2
• Onset of action can be as early as 10 minutes after dosing 3
• Improvement in erections is dose-related (20 mg > 10 mg > 5 mg) 2

Common Side Effects

• Headache
• Flushing
• Nasal congestion
• Dyspepsia
• These are typically mild to moderate in severity 4

By following these dosing guidelines and considering patient-specific factors, the starting dose of vardenafil can be appropriately selected to maximize efficacy while minimizing adverse effects.