Mictonorm^® 15 mg and Detrunorm^® 15 mg are coated tablets for oral use containing 15 mg of Propiverine hydrochloride (Propiverine) as active ingredient.

Mictonorm Uno^® 30 mg and Detrunorm^® XL 30 mg are capsules with a modified release formulation for oral use containing 30 mg of Propiverine hydrochloride (Propiverine) as active ingredient, to be taken only once daily.

Propiverine was developed by APOGEPHA Arzneimittel GmbH, Dresden, Germany. It is one of the most frequently prescribed drugs in treatment of urinary incontinence and overactive bladder. Comparable drugs which are available on the market are Oxybutynin, Tolterodine, Solifenacin, Darifenacine, Fesoterodine and Trospium chloride.

The special property of Mictonorm^® and Detrunorm^® is the dual mode of action:

• Inhibition of calcium influx and modulation of intracellular calcium in urinary bladder smooth muscle cells causing musculotropic spasmolysis, and
• Inhibition of the efferent neurotransmission of the nervus pelvicus due to anticholinergic action.

Because of this special dual mode of action Propiverine is not only highly efficious, but also very well tolerated (1).

Efficacy

Propiverine has been shown to be efficacious in symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome or neurogenic detrusor overactivity (detrusor hyperreflexia) from spinal cord injuries, e.g. transverse lesion paraplegia.

Tolerability

Propiverine is well tolerated, specially on a long-term basis. All adverse events are dose-dependent, transient and reversible.

The adverse events which may be associated with the drug when used according to the prescribing recommendations result primarily from the anticholinergic qualities. Among the most frequent adverse events are dryness of the mouth and accommodation disorders.

Studies

Controlled clinical trials have shown the effectiveness and tolerability in treating patients with symptoms of an overactive bladder und urinary incontinence as well as in neurogenic detrusor overactivity.

A placebo-controlled, double-blind, randomized, multicenter clinical study showed Propiverine and Oxybutynin equally effective in increasing bladder capacity and lowering bladder pressure in patients with neurogenic detrusor overactivity. Propiverine was significantly better tolerated regarding anticholinergic adverse events like dryness of the mouth (2).

The efficacy of Propiverine in patients with frequency, urgency and urge incontinence was investigated in comparison to Oxybutynin and placebo in a randomized, double-blind, multicentric clinical trial. Both drugs were significantly superior compared to placebo. Propiverine was better tolerated than Oxybutynin, especially regarding dryness of the mouth (3).

Comparable efficacy, tolerability, and improvement of quality of life of Propiverine and Tolterodine in the therapy of the symptoms of idiopathic detrusor overactivity was demonstrated in double-blind, randomized, prospective, multicentric studies (4).

Cardiac (5) and ophthalmological safety (6) were proven in double-blind trials.

A double-blind, double-dummy, randomized, multicentric study showed, that Propiverine 30 mg once daily and Propiverine 15 mg twice daily significantly reduce the number of incontinence episodes/24 h. Both formulations are safe and well tolerated (7).

A randomized, double-blind, placebo-controlled trial showed the significant superiority of Propiverin over placebo in all efficacy parameters (incontinence episodes/d, micturition frequency/d, maximum voided volume) and demonstrated the convincing tolerability for the treatment of children aged five to ten years with OAB and urinary incontinence (8).

 

Because of its well documented effects in the treatment of detrusor overactivity and urinary incontincence in adults and its side effects profile, Propiverine was awarded A1 (best possible) for its "level of evidence" and A (best possible) for its "grade of recommendation" at the "International Consultation on Incontinence" in Monaco 1998, in Paris 2001, in Monaco 2004 and in Paris 2008.

Approvals for Propiverine have been issued in Bolivia, Croatia, the Czech Republic, the Dominican Republic, Germany, Greece, Guatemala, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxemburg, Malaysia, the Philippines, Portugal, the Republic of Korea, Singapore, Slovakia, Slovenia, South Africa, Thailand, Turkey, the United Arab Emirates and the United Kingdom.

APOGEPHA Arzneimittel GmbH has granted a licence to Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan) under the trademark BUP-4^® for Japan and Korea.

We would be very pleased to send you more information about Propiverine, just drop us a line.