Propiverin

Generic name
Propiverin
Brand name
ATC Code
G04BD06
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Propiverin

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
  ≤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;

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Urinary incontinence and / or increased frequency and urge in patients with neurogenic detrusor hyperactivity due to spinal cord damage
  • Oral
    • 1 year up to 18 years
      • 0.8 mg/kg/day in 2 - 3 doses. Max: 30 mg/day.

      • Propiverine should be titrated for a few days. The maintenance dose should be determined individually for the patient depending on the effect or tolerability.
Urinary incontinence and / or increased frequency and urge in patients with overactive bladder
  • Oral
    • 5 years up to 18 years
      • 0.8 mg/kg/day in 2 - 3 doses. Max: 30 mg/day.

      • Propiverin should be titrated for a few days. The maintenance dose should be determined individually for the patient depending on the effect or tolerability.

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]

 

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.]

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.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

UROLOGICALS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

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

References

  1. Apogepha, SmPC Mictonetten® 5 mg (3000576.00.00), 03/2016
  2. APOGEPHA Arzneimittel GmbH, SmPC Mictonetten® 10 mg (95056.00.00), 08/2019
  3. 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
  4. Schulte-Baukloh H., et al., Urodynamic effects of propiverine in children and adolescents with neurogenic bladder, 2012
  5. Kim, W. et al., Efficacy and Safety of Propiverine in Children with Overactive Bladder, 2012
  6. Siegmund, W. et al., Pharmacokinetics and Pharmacodynamics of Propiverine in Children Aged between 5 and 10 Years with Symptoms of Overactive Bladder, 2010
  7. Marschall-Kehrel, D. et al., Treatment with Propiverine in Children Suffering from Nonneurogenic Overactive Bladder and Urinary Incontinence, 2009
  8. Madersbacher, H. et al., Propiverine vs oxybutynin for treating neurogenic detrusor overactivity in children and adolescents, 2009
  9. Grigoleit, U. et al., Efficacy, Tolerability and Safety of Propiverine Hydrochloride in Children and Adolescents with Congenital or Traumatic Neurogenic Detrusor Overactivity, 2006
  10. Otto-Unger, G. et al., Treatment of the unstable bladder in children with the anticholinergic agent propiverin hydrochloride (mictonorm/mictonets), 1985

Changes

Therapeutic Drug Monitoring


Overdose