SOLICARE

What it is

SOLICARE is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency. The active ingredient, 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. SOLICARE is available as 5 mg and 10 mg film-coated tablets containing solifenacin succinate, corresponding to 3.8 mg and 7.5 mg solifenacin respectively.

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. 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 once daily. No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh B) should be treated with caution and receive no more than 5 mg once daily. SOLICARE 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, and coadministration of drugs known to prolong the QT interval) and relevant pre-existing cardiac diseases (such as myocardial ischaemia, arrhythmia, and congestive heart failure). Appropriate investigations (for example, ECG) should be considered in patients with risk factors for QTc prolongation. The most frequent reason for discontinuation due to an adverse event in clinical trials was dry mouth, occurring in 1.5% of patients. The adverse events most commonly reported were dry mouth (27.6% at 10 mg dose), constipation (13.4% at 10 mg dose), vision blurred (4.8% at 10 mg dose), and urinary tract infection (4.8% at 10 mg dose).

Contraindications

SOLICARE 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, and patients undergoing haemodialysis. SOLICARE is contraindicated in patients with severe hepatic impairment (Child-Pugh C). SOLICARE is contraindicated in patients with severe renal impairment or moderate hepatic impairment who are on treatment with a potent CYP3A4 inhibitor, such as ketoconazole. Safety and effectiveness in children have not been established. Therefore, solifenacin should not be used in children.

Regulatory history

SOLICARE solifenacin succinate 5 mg and 10 mg tablet blister packs were first listed on the ARTG on 19 May 2016.