VESOXX

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 the following age groups Age group Age [years] Recommended daily starting dose [mg] Recommended total daily dose [mg] Children 6 - 12 individual, see below 2 - 30 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 and 3). 1 mg/kg intravesically in the morning. The dose can be adjusted after one week of treatment. Lowest effective dosing should be chosen. The daily dose may be increased up to 30 mg daily to achieve adequate effect, provided that side effects are tolerated.

Not more than 10 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. 4). Hepatic or renal impairment Vesoxx/ Oxybutynin hydrochloride 1mg/ml intravesical solution should be used with caution in patients with hepatic or renal impairment.

Undesirable effects observed with oxybutynin hydrochloride such as dry mouth, somnolence, and constipation mainly reflect the typical anticholinergic properties of the active ingredient. Table 4 includes adverse reactions from clinical trials with intravesical use of oxybutynin hydrochloride.

The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).

3). Paediatric population Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions. Adverse reactions known to be associated with anticholinergic therapy, but not observed with intravesical use of oxybutynin during clinical studies are vomiting, anorexia, decreased appetite, dysphagia, gastroesophageal reflux disease, pseudo-obstruction in patients at risk (elderly or patients with constipation and treated with other drugs that decrease intestinal motility), confusional state, agitation, anxiety, nightmares, paranoia, symptoms of depression, dependence to oxybutynin (in patients with history of drug or substance abuse), arrhythmia, heat stroke, angle closure glaucoma, ocular hypertension, dry skin, angioedema, urticaria, photosensitivity, hypersensitivity.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

If urinary tract infection is present, an appropriate antibacterial therapy should be started. Vesoxx/ Oxybutynin hydrochloride 1mg/ml intravesical solution should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics.

g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly (over 65 years) patients. 5). If a patient experiences such events, drug discontinuation should be considered. 5). The use/administration of oxybutynin products may warrant the following cautionary statements: Gastrointestinal disorders Anticholinergic medicinal products may decrease gastrointestinal motility and should be used with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.

They should also be used with caution in patients who have hiatus hernia/gastro-oesophageal reflux. 2). Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as oxybutynin are used in a hot environment.

Oxybutynin may exacerbate the symptoms of hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension and prostatic hypertrophy. Since oxybutynin may trigger narrow-angle glaucoma the patient should be instructed to immediately contact a physician if they are aware of a sudden loss of visual acuity or ocular pain.

Visual acuity and intraocular pressure should be followed during treatment occasionally. Oxybutynin may lead to suppressed salivary secretions which could result in dental caries, parodontosis or oral candidiasis. The risk for anticholinergic adverse events is clearly lower with intravesical use compared to oral administration.

This is probably due to oxybutynin being absorbed over a longer period with a delayed peak serum level and a lower degree of metabolism to the active metabolite N-desethyloxybutynin which is the main cause of these side effects. Paediatric population In children Vesoxx/ Oxybutynin hydrochloride 1mg/ml intravesical solution should be used with caution as they may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.

1 - Severe gastro-intestinal condition (e. g. severe ulcerative colitis and toxic megacolon) - Myasthenia gravis - Narrow angle glaucoma and in patients who are at risk for these conditions. - Patients with urinary obstruction where urinary retention may occur.

- Frequent urination at night caused by heart or kidney disease. - Concomitant oxygen therapy