What is Vivanza?
Vivanza is a medicine that contains the active substance vardenafil. It is available as orange round tablets (5, 10 and 20 mg).
What is Vivanza used for?
Vivanza is used to treat adult men with erectile dysfunction (also called impotence), which is the "inability to achieve or maintain" an erection sufficient for satisfactory sexual activity. Sexual stimulation is required for Vivanza to take effect.
The medicine can only be obtained with a prescription.
How is Vivanza used?
The recommended dose of Vivanza is 10 mg taken with or without food, approximately 25 to 60 minutes before sexual activity. If Vivanza is taken with a high-fat meal, the effect may be delayed. Depending on the efficacy and side effects, the dose may be increased to 20 mg or reduced to 5 mg. Patients with liver problems or severe kidney problems should start treatment with a dose of 5 mg. It is not recommended to take more than one tablet per day.
How does Vivanza work?
The active substance in Vivanza, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works by blocking the phosphodiesterase enzyme which normally lowers the levels of a substance called cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, the penis produces cGMP which causes relaxation of the spongy muscles of the penis (corpora cavernosa), allowing the penis to relax. blood supply to the corpora cavernosa, which produces an erection. By blocking the reduction of cGMP, Vivanza restores erectile function. Sexual stimulation is always required to produce an erection.
How has Vivanza been studied?
There were four main studies involving Vivanza in 2 431 male patients aged 20 to 83 years, where the medicine was compared with placebo (a dummy treatment). One study was conducted in diabetic men and another in patients whose prostate had been removed. The main measure of effectiveness was the ability to get and maintain an erection, as measured by two questionnaires completed at home.
What benefit has Vivanza shown during the studies?
Vivanza was significantly more effective than placebo in all measures and in all studies.
What are the risks associated with Vivanza?
The most common side effects (seen in more than one in 10 patients) are headache and redness of the skin. For the full list of side effects reported with Vivanza, see the package leaflet.
Vivanza must not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients. It should not be used in cases where sexual activity is not recommended (eg in men who have serious heart conditions such as unstable angina or severe heart failure). The medicine should also not be taken by people who have suffered from loss of blood. vision due to problems with blood flow to the optic nerve (non-arteritic anterior ischemic optic neuropathy - NAION). Vivanza should not be taken concomitantly with nitrates (medicines used to treat angina). Since Vivanza has not been studied in patients with severe liver or kidney problems, people who have blood pressure problems or who have had a stroke or heart attack in the past six months should not use it.
Vivanza must not be taken with medicines, such as ketoconazole and itraconazole (to treat fungal infections), by men over the age of 75 or ritonavir and indinavir (to treat AIDS patients).
Why has Vivanza 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 therefore recommended the granting of the marketing authorization for Vivanza.
Learn more about Vivanza
On 4 March 2003 the European Commission issued a "marketing authorization" for Vivanza, valid throughout the European Union. The "marketing authorization" was renewed on 4 March 2008. The holder of the marketing authorization "placing on the market is Bayer Schering Pharma AG.
For the full version of Vivanza's EPAR, click here.
Last update of this summary: 07-2009.
The information on Vivanza - vardenafil published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
