Vesican ODT

What it is

Vesican ODT is an orodispersible tablet containing solifenacin succinate, available in 5 mg and 10 mg strengths. Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergic mediated functions, including contractions of urinary bladder smooth muscle and stimulation of the salivary secretion.

Approved indications

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

Dosing overview

The recommended dose for adults, including the elderly, is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to a maximum of 10 mg solifenacin succinate once daily. Vesican ODT should be taken orally and should be sucked until completely disintegrated. It can be taken with or without food. 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 B) should be treated with caution and receive no more than 5 mg once daily. The maximum dose of Vesican ODT 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, 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 (e.g. ECG) should be considered in patients with risk factors for QTc prolongation. Since solifenacin, like other anticholinergics 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 condition (including toxic megacolon and gastric retention), myasthenia gravis, patients undergoing haemodialysis, severe hepatic impairment, and patients with severe renal impairment or moderate hepatic impairment who are on treatment with a potent CYP3A4 inhibitor.

Regulatory history

Vesican ODT 5 mg and 10 mg orodispersible tablets were first listed on the ARTG on 17 September 2020.