What is Kentera?
Kentera is a transdermal patch (a patch that carries the drug through the skin) that contains the active ingredient oxybutynin.
What is Kentera used for?
Kentera is used to treat urgency incontinence (sudden absence of urination control), increased urinary frequency (need to urinate frequently) and bladder tenesmus (sudden urgency to urinate) in adults with overactive bladder (sudden contraction of bladder muscles).
The medicine can only be obtained with a prescription.
How is Kentera used?
The recommended dosage of Kentera is a patch applied twice a week. The patch should be applied to the dry and intact skin of the abdomen, hip or buttocks immediately after removing it from the protective sachet. A new application site must be chosen for each new patch so as to avoid using the same area of skin more than once a week.
How does Kentera work?
The active substance in Kentera, oxybutynin, is an anticholinergic medicine. It blocks some receptors in the body, called muscarinic M1 and M3 receptors. In the bladder this causes the release of the muscles that push the urine out. This causes an increase in urine that the bladder can hold and changes the way the bladder muscles contract as the bladder fills.
This allows Kentera to prevent involuntary urination. Oxybutynin has been available on the market since the 1970s, in the form of tablets for overactive bladder treatment.
How has Kentera been studied?
Kentera has been the subject of two main studies involving a total of 881 patients, mainly women of advanced age, with overactive bladder. In one study, Kentera was compared with placebo (an ineffective substance on the body) in 520 patients. In the other study, Kentera was compared with tolterodine in capsules (another medicine used to treat urge incontinence) on 361 patients. The main measure of effectiveness was the number of incontinence episodes over a period of three or seven days.
What benefit has Kentera shown during the studies?
Kentera was more effective than placebo. After 12 weeks, the average number of incontinence episodes per week was reduced by 19 (approximately three per day) with Kentera, compared to a reduction of 15 episodes in the placebo group. Kentera was just as effective as tolterodine; both treatments reduced the number of episodes by about three a day.
What is the risk associated with Kentera?
Application site reactions (including itching around the site of patch application) are the most common side effects of Kentera (seen in more than 1 in 10 patients). For the full list of all side effects reported with Kentera, see the Package Leaflet. Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients. The medicine should not be used in patients with urinary retention (difficulty in emptying the bladder), severe gastrointestinal disorders (stomach and bowel problems), uncontrolled narrow-angle glaucoma (increased eye pressure despite treatment) or myasthenia gravis ( a disease of the nervous system and muscles that causes muscle weakness) or in patients at risk of such conditions.
Why has Kentera been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the effectiveness of Kentera is similar to
that of oxybutynin tablets already on the market. The committee decided that Kentera's benefits outweigh the risks in the symptomatic treatment of urgency incontinence and / or increased urinary frequency and bladder tenesmus that may affect patients with overactive bladder syndrome. Therefore, the committee recommended that Kentera be given marketing authorization.
More information on Kentera:
On 15 June 2004, the European Commission granted Kentico's marketing authorization to Nicobrand Limited, valid throughout the European Union. The marketing authorization was renewed on 15 June 2009.
The full EPAR for Kentera can be found here.
Last update of this summary: 06-2009.
