Composition

Each film-coated tablet of PowerBox 5 mg contains:

• Vardenafil HCl equivalent to 5 mg of vardenafil.
• Excipient: S.Q. for one film-coated tablet.

Indications

PowerBox is indicated for the treatment of erectile dysfunction in men.

Dosage & Administration

For most patients:

The recommended starting dose of PowerBox is 10 mg taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is one per day. PowerBox can be taken with or without food. Sexual stimulation is required for a response to treatment.

Geriatrics:

A starting dose of 5 mg should be considered in patients 65 years of age.

Hepatic impairment:

• For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of PowerBox is required.
• For patient with moderate hepatic impairment (Child-Pugh B), starting dose of 5 mg PowerBox is recommended, the maximum dose should not exceed 10 mg.
• For patients with severe hepatic impairment (Child-Pugh C), vardenafil has not been evaluated; therefore PowerBox should not be taken.

Renal impairment:

For patients with mild (CLcr = 50 – 80 ml/min), moderate (CLcr= 30-50 ml/min), or severe (CLcr < 30 ml/min) renal impairment, no dose adjustment is required. Vardenafil has not been evaluated in patients on renal dialysis.