What is it?

Vivanza is a medicine that contains the active substance vardenafil. It is available as round, orange tablets (5, 10 and 20 mg).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Vivanza is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity. For Vivanza to be effective, sexual stimulation is required.
The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Vivanza is 10 mg, taken with or without food, about 25 to 60 minutes before sexual activity. If Vivanza is taken with a high fat meal, the onset of activity may be delayed. The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on the effectiveness and side effects. Patients with liver problems or severe kidney problems should start treatment on the 5 mg dose. The maximum recommended dosing frequency is one tablet per day.

How does it work?

The active ingredient of Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax. This allows blood to flow into the corpora, producing the erection. By blocking the breakdown of cGMP, Vivanza restores erectile function. Sexual stimulation is still needed to produce an erection.

How has it been studied?

Vivanza has been compared with placebo (a dummy treatment) in four main studies including 2,431 men aged 20 to 83 years. One study was carried out in diabetic men and another in men who had had their prostate gland removed. The main measure of effectiveness was the ability to get and maintain an erection. This was recorded in two questionnaires completed at home.

What benefits has it shown during the studies?

Vivanza was significantly more effective than placebo for all measures in all studies.

What is the risk associated?

The most common side effects with Vivanza (seen in more than 1 patient in 10) are headache and flushing (reddening of the skin). For the full list of all side effects reported with Vivanza, see the Package Leaflet.
Vivanza should not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients. It must not be used when sexual activity is inadvisable (e.g. in men with severe heart disease such as unstable angina or severe heart failure). It must also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION). Vivanza must not be taken with nitrates (medicines used to treat angina). Because Vivanza has not been studied in patients with severe liver or kidney disease, patients who have problems with their blood pressure, or who have had a stroke or a heart attack within the last six months, these patients must not use it.
Vivanza must not be taken with some medicines, such as ketoconazole and itraconazole (to treat fungal infections) in men over 75 years, or ritonavir or indinavir (to treat HIV infection).

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Vivanza?s benefits are greater than its risks for the treatment of men with erectile dysfunction. The Committee recommended that Vivanza be given marketing authorisation.

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