VESICARE

What it is

Vesicare is available as film-coated tablets in two strengths: 5 mg (containing 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin) and 10 mg (containing 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin). Solifenacin is a competitive muscarinic receptor antagonist.

Approved indications

— Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Dosing overview

The recommended dose is 5 mg solifenacin succinate once daily, which may be increased to a maximum of 10 mg solifenacin succinate once daily if needed. Patients with mild to moderate renal impairment do not require dose adjustment, while 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 mild hepatic impairment do not require dose adjustment, while patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. The maximum dose should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors such as ritonavir, nelfinavir, itraconazole, cyclosporin, or macrolide antibiotics.

Key safety warnings

Angioedema with airway obstruction has been reported in some patients on solifenacin succinate. If angioedema occurs, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. Anaphylactic reaction has been reported in some patients treated with solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures taken. QT prolongation and Torsade de Pointes have been observed in patients with known risk factors for these conditions. Caution is advised in patients with known risk factors for QT prolongation (history of QT prolongation, long QT syndrome, hypokalaemia, bradycardia, coadministration of drugs known to prolong the QT interval) and relevant pre-existing cardiac diseases (myocardial ischaemia, arrhythmia, congestive heart failure). Appropriate investigations such as ECG should be considered in patients with risk factors for QTc prolongation. Since solifenacin may cause blurred vision, and uncommonly somnolence and fatigue, the ability to drive and use machines may be negatively affected.

Contraindications

Solifenacin is contraindicated in patients with urinary retention, uncontrolled narrow-angle glaucoma, hypersensitivity to the drug substance or other components of the product, severe gastro-intestinal conditions (including toxic megacolon and gastric retention), myasthenia gravis, or those undergoing haemodialysis. Vesicare is contraindicated in patients with severe hepatic impairment (Child-Pugh C).

Regulatory history

Vesicare solifenacin succinate 5 mg and 10 mg tablets were first listed on the Australian Register of Therapeutic Goods on 28 August 2006.