Oxybutynin

Generic name
Oxybutynin
Brand name
ATC Code
G04BD04
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Oxybutynin

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 have been observed (Autret 1993):

Age n= Dose Cmax mean (range) Tmax
5-8 years 10 0.2 mg/kg/day 9±6.6 (1.7–30.5) ng/ml 1-2 hours
10-13 years 8 0.3 mg/kg/day - (2.7-23.2) ng/ml 1-2 hours

No pharmacokinetic parameters are known for intravesical application.

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, bladder cramps, improvement of the bladder function after urethral valve ablation
  • Oral
    • < 37.5 kg
      • (Oxybutinin hydrochloride) Initially: 0.4 mg/kg/day in 3 - 4 doses.

      • Doses of up to 0.6 mg//kg/day have also been used in the literature, with a maximum of 5 mg/dose [Buyse ’98, Kaefer ‘99]

    • ≥ 37.5 kg
      • (Oxybutinin hydrochloride) 15 mg/day in 3 doses.
Urinary incontinence, overactive bladder syndrome, neurogenic bladder
  • Intravesical
    • 1 year up to 18 years
      • (Oxybutinin hydrochloride)  0.2 - 0.4 mg/kg/day in 2 - 3 doses. Max: 0.9mg/kg/day, but not exceeding 40 mg/day. Max single dose: 10 mg/dose.

      • Titrate on efficacy.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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 children, excitation of the CNS can occur, including restlessness, anxiety, disorientation, hallucinations and rarely convulsions. Anticholinergic side effects, e.g. xerostomia, flush;

The Dutch pharmacovigilance centre LAREB received reports on 53 children (average age 7.2 years SD +/1 3.2 years). Headache, agitation, aggression, abnormal behaviour, restlessness and psychomotor hyperactivity were the most frequently reported side effects. Two children were admitted to hospital with psychosis due to these suspected side effects.

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

Children are often more sensitive to parasympatholytic drugs; accurate regulation of the dosage is therefore required. Watch out for urinary retention; do not give when the outdoor temperature is > 30 degrees Celsius. Watch out for side effects on the mood.

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
G04BD06
G04BD08
G04BD07
G04BD09
Drugs used in erectile dysfunction
G04BE03
G04BE08
Other urologicals
G04BX16
OTHER UROLOGICALS
G04BX16

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Nycomed BV, SPC Dridase (RVG 10528) 01-12-2014, www.geneesmiddeleninformatiebank.nl
  3. Diverse fabrikanten, SmPC Oxybutinine (RVG 25099, 18780) , www.geneesmiddeleninformatiebank.nl
  4. Autret E et al., Plasma levels of oxybutynine chloride in children., Eur J Clin Pharmacol., 1994, 46(1), 83-5
  5. Baek M et al, Treatment outcomes according to neuropathic bladder sphincter dysfunction type after treatment of oxybutynin chloride in children with myelodysplasia, Int Urol Nephrol., 2013, Jun;45(3), 703-9
  6. Casey JT et al., Early administration of oxybutynin improves bladder function and clinical outcomes in newborns with posterior urethral valves., J Urol., 2012, Oct;188(4 Suppl), 1516-20
  7. Ab E., Detrusor overactivity in spina bifida: how long does it need to be treated?, Neurourol Urodyn., 2004, 23(7), 685-8
  8. Ferrara P et al., Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida., BJU Int., 2001, May;87(7), 674-8
  9. Kaefer M et al, Improved bladder function after prophylactic treatment of the high risk neurogenic bladder in newborns with myelomentingocele., J Urol., 1999, Sep;162(3 Pt 2), 1068-71
  10. Goessl C et al. , Urodynamic effects of oral oxybutynin chloride in children with myelomeningocele and detrusor hyperreflexia. , Urology., 1998 , Jan;51(1), 94-8
  11. Baskin LS et al, Treatment of infants with neurogenic bladder dysfunction using anticholinergic drugs and intermittent catheterisation., Br J Urol., 1990, Nov;66(5), 532-4
  12. Buyse G et al, Intravesical oxybutynin for neurogenic bladder dysfunction: less systemic side effects due to reduced first pass metabolism, J Urol., 1998, Sep;160(3 Pt 1), 892-6
  13. Sammour ZM et al., The effects of oxybutynin on urinary symptoms in children with Williams-Beuren syndrome., J Urol., 2012, Jul;188(1), 253-7
  14. MMI, Gelbe Liste Online, Accessed March 16, 2018
  15. Nicobrand, SmPC Kentera® 3,9 mg/24 Stunden transdermales Pflaster (EU/1/03/270/001, EU/1/03/270/002, EU/1/03/270/003), 12/2016
  16. ratiopharm GmbH, SmPC Oxybutynin-ratiopharm® 2,5 mg/ 5mg Tabletten (43986.00.00, 39432.00.00), 03/2015
  17. Sanofi-Aventis, SmPC Dridase®5 mg Tabletten (8070.00.00), 03/2015
  18. Lazarus J., Intravesical oxybutynin in the pediatric neurogenic bladder, Nat Rev Urol, 2009, Dec;6(12), 671-4
  19. Aslan AR, et al, Conservative management in neurogenic bladder dysfunction, Curr Opin Urol, 2002, Nov;12(6), 473-7
  20. Lose G, et al, Intravesical oxybutynin for treating incontinence resulting from an overactive detrusor, BJU Int, 2001, Jun;87(9), 767-73
  21. Guerra LA, et al, Intravesical oxybutynin for children with poorly compliant neurogenic bladder: a systematic review, J Urol, 2008, Sep;180(3), 1091-7
  22. Verpoorten C, et al, The neurogenic bladder: medical treatment, Pediatr Nephrol, 2008, May;23(5), 717-25
  23. Haferkamp A, et al, Dosage escalation of intravesical oxybutynin in the treatment of neurogenic bladder patients, Spinal Cord, 2000, Apr;38(4), 250-4
  24. Kaplinsky R, et al, Expanded followup of intravesical oxybutynin chloride use in children with neurogenic bladder, J Urol, 1996, Aug;156(2 Pt 2), 753-6
  25. Lee, Ze-Yun et al, <Children experience neuropsychiatric side effects with oxybutynin.>, Pharm. Weekb, 11-03-2022, 10, 18-21
  26. FARCO-PHARMA GmbH, SmPC Vesolox (121012) 8-11-2023, Geneesmiddeleninformatiebank
  27. Buyse G et al, Intravesical oxybutynin for neurogenic bladder dysfunction: less systemic side effects due to reduced first pass metabolism, J Urol., 1998, Sep;160(3 Pt 1), 892-6
  28. Lazarus J., Intravesical oxybutynin in the pediatric neurogenic bladder, Nat Rev Urol, 2009, Dec;6(12), 671-4
  29. Diverse fabrikanten, SmPC Oxybutinine (RVG 25099, 18780), www.geneesmiddeleninformatiebank.nl
  30. Goessl C et al., Urodynamic effects of oral oxybutynin chloride in children with myelomeningocele and detrusor hyperreflexia., Urology., 1998, Jan;51(1), 94-8
  31. Haferkamp A, et al, Dosage escalation of intravesical oxybutynin in the treatment of neurogenic bladder patients, Spinal Cord, 2000, Apr;38(4), 250-4

Changes

Therapeutic Drug Monitoring


Overdose