What is Kentera?
Kentera is a transdermal patch (a patch that carries medicine through the skin) that contains the active substance oxybutynin.
What is Kentera used for?
Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and bladder tenesmus (sudden urge to urinate) in adults with an overactive bladder (sudden contraction of the bladder). bladder muscles).
The medicine can only be obtained with a prescription.
How is Kentera used?
The recommended dosage of Kentera is one patch applied twice a week. The patch should be applied to dry, intact skin on the abdomen, flank or buttocks immediately after taking it out of the protective sachet. A new application site should be chosen for each new patch, in order 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 certain receptors in the body, called muscarinic M1 and M3 receptors. In the bladder, this releases the muscles that push urine out. This increases the amount of urine 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 the treatment of overactive bladder.
How has Kentera been studied?
Kentera has been studied in two main studies involving a total of 881 patients, mainly women of advanced age, with overactive bladders. In one study, Kentera was compared with placebo (a substance that had no effect on the body) in 520 patients. In the other study, Kentera was compared with tolterodine capsules (another medicine used to treat urge incontinence). of 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 mean number of incontinence episodes per week was reduced by 19 (approximately three per day) with Kentera, compared with 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 per day.
What is the risk associated with Kentera?
Application site reactions (including itching around the patch application site) are the most common side effects of Kentera (seen in more than 1 in 10 patients). For the full list of 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 emptying the bladder), severe gastrointestinal disorders (stomach and bowel problems), uncontrolled angle-closure glaucoma (increased eye pressure despite treatment) or myasthenia gravis ( a disease of the nervous system and muscles causing muscle weakness) or in patients at risk for these conditions.
Why has Kentera been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the efficacy of Kentera is similar to
that of the oxybutynin tablets already on the market. The Committee decided that Kentera's benefits are greater than its risks in the symptomatic treatment of urge incontinence and / or increased urinary frequency and bladder tenesmus which may affect patients with overactive bladder syndrome. Therefore, the committee recommended the granting of the marketing authorization for Kentera.
Other information about Kentera:
On 15 June 2004, the European Commission granted Nicobrand Limited a "Marketing Authorization" for Kentera, valid throughout the European Union. The "Marketing Authorization" was renewed on 15 June 2009.
For the full version of Kentera's EPAR click here.
Last update of this summary: 06-2009.
The information on Kentera - oxybutynin 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.
