Kentera 3.9 mg / 24 hours transdermal patch

ATC Code
G04BD04
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About this drug

Admission country
Manufacturer Nicobrand Ltd.
Narcotic drug No
Psychotropic No
Anatomical group Urogenitalsystem und sexualhormone
Therapeutic group Urologika
Pharmacological group Urologika
Chemical group Mittel bei häufiger blasenentleerung und harninkontinenz
Substance Oxybutynin

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All to know

Author

Nicobrand Ltd.

What is it?

Kentera is a transdermal patch (a patch that delivers a medicine across the skin). It contains the active substance oxybutynin.

What is it used for?

Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) in adults with an overactive bladder (when the bladder muscles contract suddenly).
The medicine can only be obtained with a prescription.

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How is it used?

The recommended dose of Kentera is one patch twice a week. The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet. A new application site should be chosen for each new patch so that the same area of skin is not used more than once within a week.

How does it 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 muscles that push urine out of the bladder to relax. This leads to an increase in the amount of urine that the bladder can hold, and to changes in the way the bladder muscles contract as the bladder fills up. This helps Kentera to prevent unwanted urination. Oxybutynin has been available as a tablet for the treatment of overactive bladder since the 1970s.

How has it been studied?

Kentera has been studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies. In one study, Kentera was compared with placebo (a dummy treatment) in 520 patients. In the other, Kentera was compared with tolterodine capsules (another medicine used to treat urge incontinence) in 361 patients. The main measure of effectiveness was the number of incontinence episodes over either three or seven days.

What benefits has it shown during the studies?

Kentera was more effective than placebo. After 12 weeks, the average number of incontinence episodes per week had decreased by 19 (about three per day) with Kentera, compared with a decrease of 15 episodes with placebo. Kentera was as effective as tolterodine, with both treatments decreasing the number of episodes by about three per day.

What is the risk associated?

The most common side effects with Kentera (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application). 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. It must not be used in patients with urinary retention (difficulty in passing urine), severe gastro-intestinal conditions (problems with the stomach and gut), uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves and muscles causing muscle weakness), or in patients at risk of these conditions.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Kentera was similar to that of the oxybutynin tablets already on the market. The Committee decided that Kentera?s benefits are greater than its risks for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. The Committee recommended that Kentera be given marketing authorisation.

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