Solifenacine

Generic name
Solifenacine
Brand name
ATC Code
G04BD08
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Solifenacine

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The pharmacokinetic parameters in children (2-18 years) in which the dose was adjusted for bodyweight was comparable to that in adults after correction for body weight. [SmPC]

Vd  8,6 l/kg
T1/2 45-68 hour
Tmax 4-12 hour
Cl 9,5 l/hour

 

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

Overactivity of the neurogenic detrusor
  • Oral
    • 2 years up to 18 years and 9 up to 16 kg
      • 2 mg/day in 1 dose. Max: 4 mg/day.
    • 2 years up to 18 years and 16 up to 31 kg
      • 3 mg/day in 1 dose. Max: 5 mg/day.
    • 2 years up to 18 years and 31 up to 46 kg
      • 3 mg/day in 1 dose. Max: 6 mg/day.
    • 2 years up to 18 years and 46 up to 61 kg
      • 4 mg/day in 1 dose. Max: 8 mg/day.
    • 2 years up to 18 years and ≥ 61 kg
      • 5 mg/day in 1 dose. Max: 10 mg/day.

Renal impaiment in children > 3 months

  • Creatinineklaring > 30 ml/min:  Dose adjustment not needed
  • Creatinineklaring < 30 ml/min: do not exceed the starting dose once day. Cautious treatment is indicated

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

In general, the safety profile in children is comparable to that of adults. The following side effects were observed in children: dry mouth, constipation (especially at maximum dose), abdominal pain, drowsiness, urinary tract infection and prolonged QT interval.

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

The suspension Vesicare contains propyleenglycol 20 mg/ml and ethanol 10 mg/ml

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
G04BD06
G04BD07
G04BD09
Drugs used in erectile dysfunction
G04BE03
G04BE08
Other urologicals
G04BX16
OTHER UROLOGICALS
G04BX16

Reference

  1. Astellas Pharma Europe B.V, SmPC Vesicare (RVG 116539) 18-10-2019, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose