SOLIFENACIN LUPIN

What it is

Solifenacin Lupin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency. Solifenacin is a competitive muscarinic receptor antagonist. The medicine is available as film-coated tablets containing 5 mg or 10 mg of solifenacin succinate.

Approved indications

— 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. Solifenacin Lupin should be taken orally and swallowed whole with liquids. It can be taken with or without food.

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. As with other drugs in this class, caution is advised in patients with known risk factors for QT-prolongation (such as history of QT prolongation, long QT syndrome, hypokalaemia, bradycardia, or coadministration of drugs known to prolong the QT interval) and relevant pre-existing cardiac diseases (including myocardial ischaemia, arrhythmia, congestive heart failure). The most frequent reason for discontinuation due to an adverse event in clinical trials was dry mouth, at 1.5%. Dry mouth occurred in 10.9% of patients taking 5 mg and 27.6% of those taking 10 mg, compared with 4.2% on placebo. Solifenacin, like other anticholinergics, may cause blurred vision and uncommonly somnolence and fatigue, which may negatively affect the ability to drive and use machines.

Contraindications

Solifenacin Lupin 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, and patients with severe hepatic impairment. It is also contraindicated in patients with severe renal impairment or moderate hepatic impairment who are on treatment with a potent CYP3A4 inhibitor.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

Solifenacin Lupin was first registered on the ARTG on 29 May 2019. Two strengths are registered: solifenacin succinate 5 mg (ARTG 296743) and 10 mg (ARTG 296748) film-coated tablets in blister packs.