Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Vesicare oral suspension is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (OAB) syndrome.
Vesicare oral suspension is indicated for treatment of neurogenic detrusor overactivity (NDO) in paediatric patients aged 2 to 18 years.
The recommended dose is 5 mg (5 ml) solifenacin succinate once daily. If needed, the dose may be increased to 10 mg (10 ml) solifenacin succinate once daily.
The efficacy of Vesicare in children and adolescents with overactive bladder has not been established. Therefore, Vesicare should not be used for treatment of overactive bladder in children and adolescents under 18 years of age. Currently available data are described in Section 5.1 and 5.2.
The recommended dose of Vesicare oral suspension is determined based on patient weight. Treatment should be initiated at the recommended starting dose. Thereafter, the dose may be increased to the lowest effective dose. The maximum dose should not be exceeded. During long-term therapy, patients should be periodically evaluated for treatment continuation and for potential dose adjustment, at least annually or more frequently if indicated. The doses according to the patient’s body weight are found in the table below.
| Weight range (kg) | Starting dose (ml)§1 | Maximum dose (ml)§2 |
|---|---|---|
| 9 to 15 | 2 | 4 |
| >15 to 30 | 3 | 5 |
| >30 to 45 | 3 | 6 |
| >45 to 60 | 4 | 8 |
| >60 | 5 | 10 |
§ The oral suspension formulation of Vesicare has a concentration of 1 mg/ml.
1 Equivalent to steady-state exposure after a 5 mg daily dose in adults
2 Equivalent to steady-state exposure after a 10 mg daily dose in adults
Vesicare oral suspension should be taken once daily by mouth.
Vesicare oral suspension should not be used in children below age of 2 years.
No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance >30 ml/min). Patients with severe renal impairment (creatinine clearance ≤30 ml/min) should be treated with caution and receive no more than 5 mg (5 ml) once daily (adults) and no more than the starting dose (children and adolescents) (see Section 5.2).
No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg (5 ml) once daily (adults) and no more than the starting dose (children and adolescents) (see Section 5.2).
The maximum dose of Vesicare oral suspension should be limited to 5 mg (5 ml) (adults) and no more than the starting dose (children and adolescents) when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4-inhibitors e.g. ritonavir, nelfinavir, itraconazole (see Section 4.5).
Vesicare oral suspension should be taken orally followed by a glass of water. It should not be ingested together with food and/or other drinks. This ingestion with food and/or drinks may cause a release of solifenacin in the mouth resulting in a bitter taste and a feeling of numbness in the mouth.
An appropriate oral syringe and adaptor should be selected to measure the correct dose (see Section 6.6).
Overdosage with solifenacin can potentially result in severe anticholinergic effects. The highest dose of solifenacin accidentally given to a single patient was 280 mg in a 5-hour period, resulting in mental status changes not requiring hospitalization.
In the event of overdose with solifenacin the patient should be treated with activated charcoal. Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced.
As for other anticholinergics, symptoms can be treated as follows:
As with other antimuscarinics, in case of overdosing, specific attention should be paid to patients with known risk for QT-prolongation (i.e. hypokalaemia, bradycardia and concurrent administration of medicinal products known to prolong QT-interval) and relevant pre-existing cardiac diseases (i.e. myocardial ischaemia, arrhythmia, congestive heart failure).
Shelf life: 2 years.
After first opening of the bottle, the oral suspension can be stored for 28 days.
Store in the original bottle in order to protect from light.
This product does not require any special temperature storage conditions.
150 ml Vesicare oral suspension in amber polyethylene terephthalate (PET) bottle with polyethylene (PE) screw-cap with a pulp and vinylseal liner, packed in a carton.
No special requirements.
Discard any medicine remaining after 28 days after opening the bottle. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
An appropriate commercially available oral syringe and adaptor suitable for dispensing of liquid medicines should be selected by the health care professional to measure the correct dose. Recommended syringe capacity for measuring the dose of Vesicare oral suspension is presented in the table below.
Suggested Syringe capacity for accurate dispensing:
| Prescribed Dosing Volume | Recommended Syringe Capacity |
|---|---|
| 2 ml | 2 ml syringe |
| 2 ml-5 ml | 5 ml syringe |
| 5 ml-10 ml | 10 ml syringe |
As for the adaptor; a commercially available adaptor should be selected that is suitable for use in combination with the selected oral syringe and fits the bottle neck size for example a press in bottles adaptor, 24 mm or universal bottle adapter.
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