Usual Adult Dose for Erectile Dysfunction

• Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.
• Maximum dose: 20 mg once a day

• Initial dose: 5 mg orally once a day

• Sexual stimulation is required for a response to treatment.
• A time interval between dosing should be considered when administering this drug concomitantly with alpha-blockers.
• Patients taking alpha-blockers should not initiate vardenafil therapy with the orally disintegrating tablet.

Usual Geriatric Dose for Erectile Dysfunction

65 years or older:

• Initial dose: 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity

Renal Dose Adjustments

• CrCl: 30 to 80 mL/min: No adjustment recommended.

Liver Dose Adjustments

• Mild hepatic dysfunction (Child-Pugh A): No adjustment recommended.
• Moderate hepatic dysfunction (Child-Pugh B): 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity. The maximum dose should not exceed 10 mg.
• Severe hepatic dysfunction (Child-Pugh C): Use should be avoided.

Dose Adjustments

The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects.

If taking potent or moderate inhibitors of CYP450 3A4, the dose should be adjusted as follows:

• Ritonavir: No more than 2.5 mg in a 72-hour period
• Indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, clarithromycin: No more than 2.5 mg in a 24-hour period
• Ketoconazole 200 mg daily, itraconazole 200 mg daily, erythromycin: No more than 5 mg in a 24-hour period

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

This drug is not indicated for use in pediatric patients.

Consult WARNINGS section for additional precautions.

Dialysis

Renal dialysis: Use should be avoided.

Other Comments

Administration advice:

• This drug can be taken with or without food.
• The 10 mg orally disintegrating tablet (ODT) provides higher systemic exposure and is not interchangeable with the 10 mg film-coated tablets.
• The ODT tablet should be taken without liquid and immediately upon removal from the blister.
• Patients who require a lower or higher dose than 10 mg should be prescribed the film-coated tablets.

• Patients treated with alpha-blockers, who have previously used vardenafil film-coated tablets, may be switched to ODT tablets at the advice of their healthcare provider.
• Patients should stop use of PDE5 inhibitors, including this drug, and seek medical attention in the event of sudden loss of vision in one or both eyes, and decrease or loss of hearing.
• Symptoms related to postural hypotension may occur, appropriate countermeasures are recommended.
• Contact the prescribing physician if other antihypertensive drugs or new medications that may interact with this drug are prescribed by another healthcare provider.
• Patients should contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with this drug, or in the case of an unwanted side effect.