VESICARE 5 MG
Renal and Bladder Disorders
= Additional active ingredients
PRESENTATION AND DOSSAGE
TABS: 30 X 5 mg
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
Patients with urinary retention, severe GI condition, myasthenia gravis or narrow-angle glaucoma and in patients at risk for these conditions. Hypersensitivity to the active substance or to any of the excipients. Patients undergoing hemodialysis. Severe hepatic impairment. Patients with severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole.
Patients with severe renal impairment (creatinine clearance < 30 ml/min) should be treated with caution and receive no more than 5 mg once daily. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily. Should be taken orally and should be swallowed whole with liquids. Can be taken with or without food. Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Should be used with caution in patients with: Clinically significant bladder outflow obstruction at risk of urinary retention; GI obstructive disorders; risk of decreased GI motility; hiatus hernia/gastro-esophagal reflux and/or who are concurrently taking medicdbinal products (such as bisphosphonates) that can cause or exacerbate esophagitis; autonomic neuropathy. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicdbinal product. Pregnancy and lactation: . Caution should be exercised when prescribing to pregnant women. The use should be avoided during breast-feeding.
May cause anticholinergic undesirable effects of (in general) mild or moderate severity. Dry mouth, constipation, nausea, dyspepsia, abdominal pain, blurred vision.
Other medicdbinal products with anticholinergic properties may result in more pronounced therapeutic effects and undesirable effects. An interval of approximately one week should be allowed after stopping treatment, before commencing other anticholinergic therapy. Simultaneous administration of ketoconazole (200 mg/day), a potent CYP3A4 inhibitor, resulted in a two-fold increase of the AUC of solifenacin, while ketoconazole at a dose of 400 mg/day resulted in a three-fold increase of the AUC of solifenacin. Therefore, the maximum dose of Vesicare should be restricted to 5 mg, when used simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole). Simultaneous treatment of solifenacin and a potent CYP3A4 inhibitor is contra-indicated in patients with severe renal impairment or moderate hepatic impairment.
MANUFACTURER & DISTRIBUTER:
Manufacturer: Astellas Pharma
License Holder: CTS Chemical Ind. Ltd.