Posology : מינונים

4.2    Posology and method of administration

Posology
Initial dose adjustment shall be done by a neuro-urologist under close urodynamic control.
There are no fixed rules for the dose regimen as high interindividual differences in bladder pressure and doses required to improve neurogenic detrusor overactivity exist. The dose regimen (doses and timings) must therefore be determined individually according to the patient´s need.

Individual dosages will be applied to control uro-dynamic parameters sufficiently (maximum detrusor pressure < 40 cm H2O) aiming at complete inhibition of neurogenic detrusor overactivity.

In the course of intravesical oxybutynin therapy, urodynamic parameters shall be controlled in regular intervals as defined by the attending urologist.

Paediatric population
The safety and efficacy of oxybutynin hydrochloride in children aged 0 to 5 years of age have not yet been established.

Dose recommendations in adolescents from 12 years and above, adults and elderly The dose recommendations have been calculated according to the body weight percentiles of the different age groups (table 1).

Table 1: Dose recommendations in adolescents from 12 years and above, adults and elderly Recommended daily          Recommended total
Age group                 Age [years] starting dose [mg]          daily dose [mg]
Adolescents                       12 - 18                       10                      10 - 40 Adults                            19 - 65                       10                      10 - 40 Elderly                            over 65                      10                      10 - 30 
If higher doses than the starting dose are considered necessary, the dose should be increased using a step-wise approach until neurogenic detrusor overactivity is sufficiently controlled to allow close monitoring of both efficacy and safety. The required daily maintenance doses may be divided into several applications (table 2). Given a number of six clean intermittent catheterisations (CICs) per day, the following dose scheme is recommended:

Table 2: Recommended dose scheme for 10 mg starting doses (adolescents from 12 years and above, adults and elderly)

Daily dose                           Administered dose per application [mg] [mg]             CIC 1         CIC 2          CIC 3         CIC 4          CIC 5         CIC 6 10                5             -              5              -             -              - 20               10             -              10             -             -              -
30               10             -              10             -            10              - 40               10            10              10             -            10              -

Children (from 6 - 12 years)
The dosing is individual with a starting dose of 0.1 mg/kg intravesically in the morning and evening.
The dose can be adjusted after one week of treatment. Lowest effective dosing should be chosen. The daily dose may be increased up to 0.15 mg/kg twice daily to achieve adequate effect, provided that side effects are tolerated. Not more than 5 mg should be administered per single dose.
The safety and efficacy of oxybutynin hydrochloride in children below 6 years of age have not yet been established.

Elderly (over 65 years)
As with other anticholinergic drugs caution should be observed in frail and elderly patients, especially if doses higher than 30 mg per day are considered as required (see section 4.4).

Hepatic or renal impairment
Vesoxx should be used with caution in patients with hepatic or renal impairment. The use of Vesoxx in those patients should be carefully monitored and dose reductions may be needed (see section 4.4).

Method of administration
Intravesical use.

To ensure safe and effective treatment, patients must be familiar with the procedure of clean intermittent catheterisation (CIC). The patients and/or relative, carer shall be trained on CIC and the administration procedure by specialised health care professionals.

As soon as the environmental conditions are aseptic, a sterile disposable urethral catheter is inserted into the bladder. The bladder has to be drained completely before the instillation.
The scaled prefilled syringe is taken from the blister and the cap is removed from the syringe.

Polypropylene prefilled syringe (for direct connection with standard catheter systems) 
The tapered cone of the syringe is connected directly to the catheter. The required amount of the oxybutynin solution is instilled into the bladder by constant pressing on the plunger of the syringe.

If the application of less than 10 ml (one syringe content) is required, the solution that is not used remains in the syringe which has to be brought to a pharmacy for disposal later.

After the instillation the catheter is removed.

The instilled solution remains in the bladder until the next catheterisation.

Any unused medicinal product and the urethral catheter have to be discarded (see section 6.3).

The duration of treatment depends on the symptoms, the underlying disease and / or the treatment goal and is determined by the treating physician.