- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The following kinetic parameters were observed in 25 children between 5 and 10 years with symptoms of an overactive bladder [10]
| Propiverine | Propiverine N-oxid |
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| ≤0.3 mg/kg | 0.3 - ≤0.45 mg/kg | ≤0.3 mg/kg | 0.3 - ≤0.45 mg/kg | |
| t1/2, ss [h] | 12.2 ± 11.2 | 14.5 ± 9.94 | 10.4 ± 7.23 | 9.80 ± 4.19 |
| Cmax, ss [ng/mL] | 68.4 ± 39.7 | 152 ± 46.5 | 535 ± 254 | 1060 ± 321 |
| tmax, ss [h]b | 1.63 (0.92–3.25) | 1.50 (1.00–5.00) | 1.88 (0.92–5.87) | 1.50 (1.00–5.00) |
a Values are expressed as mean ± SD unless specified otherwise.
b Median (range).
Cmax,ss =maximum serum concentration at steady state; t1/2 = elimination half-life; tmax,ss = time to reach the Cmax at steady state;
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Urinary incontinence and / or increased frequency and urge in patients with neurogenic detrusor hyperactivity due to spinal cord damage |
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| Urinary incontinence and / or increased frequency and urge in patients with overactive bladder |
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Renal impaiment in children > 3 months
From a single dose study in 12 patients with a creatinine clearance <30 ml/min, it was concluded that severe renal impairment does not significantly alter the elimination of propiverine and its major metabolite propiverine-N-oxide. Dose adjustment is not necessary if the total daily dose does not exceed 30 mg propiverine hydrochloride. If a higher dose needs to be administered, cautious titration of the dose is recommended, taking into account the anticholinergic effects as a marker of tolerability. [SmPC (Ger) Mictonettten]
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
loss of appetite, sleep disorders, concentration disorders [SmPC (Ger) Mictonetten 10mg überzogene Tabletten (95056.00.00) 11/17/SmPC (Ger) Mictonetten 5mg überzogene Tabletten (3000576.00.00) 03/16.]
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Like all anticholinergics, propiverine has a narrow therapeutic index and should be dosed individually. While the standard dose already shows undesirable effects in some patients and therefore the dose must be reduced (e.g. by 20%), other patients require significantly higher doses to reach a sufficient effect. It is recommended to titrate propiverine slowly for a few days until the effect or side effect occurs.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Acidifiers | ||
|---|---|---|
| G04BA01 | ||
| Drugs for urinary frequency and incontinence | ||
|---|---|---|
| G04BD04 | ||
| G04BD04 | ||
| G04BD08 | ||
| G04BD07 | ||
| G04BD09 | ||
| Drugs used in erectile dysfunction | ||
|---|---|---|
| G04BE03 | ||
| G04BE08 | ||
| Other urologicals | ||
|---|---|---|
| G04BX16 | ||
| OTHER UROLOGICALS | ||
|---|---|---|
| G04BX16 | ||
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References
- Apogepha, SmPC Mictonetten® 5 mg (3000576.00.00), 03/2016
- APOGEPHA Arzneimittel GmbH, SmPC Mictonetten® 10 mg (95056.00.00), 08/2019
- Alloussi, S. et al., Efficacy, tolerability and safety of propiverine hydrochloride in comparison to oxybutynin in children with urge incontinence due to overactive bladder, 2010
- Schulte-Baukloh H., et al., Urodynamic effects of propiverine in children and adolescents with neurogenic bladder, 2012
- Kim, W. et al., Efficacy and Safety of Propiverine in Children with Overactive Bladder, 2012
- Siegmund, W. et al., Pharmacokinetics and Pharmacodynamics of Propiverine in Children Aged between 5 and 10 Years with Symptoms of Overactive Bladder, 2010
- Marschall-Kehrel, D. et al., Treatment with Propiverine in Children Suffering from Nonneurogenic Overactive Bladder and Urinary Incontinence, 2009
- Madersbacher, H. et al., Propiverine vs oxybutynin for treating neurogenic detrusor overactivity in children and adolescents, 2009
- Grigoleit, U. et al., Efficacy, Tolerability and Safety of Propiverine Hydrochloride in Children and Adolescents with Congenital or Traumatic Neurogenic Detrusor Overactivity, 2006
- Otto-Unger, G. et al., Treatment of the unstable bladder in children with the anticholinergic agent propiverin hydrochloride (mictonorm/mictonets), 1985
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Changes
Changes
