SOLIFENACIN DR.REDDY's

What it is

Solifenacin Dr.Reddy's is available as film-coated tablets containing 5 mg or 10 mg of solifenacin succinate. Solifenacin is a competitive muscarinic receptor antagonist. The tablets should be swallowed whole with liquids and can be taken with or without food.

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, which may be increased to a maximum of 10 mg solifenacin succinate once daily if needed. Patients with severe renal impairment (creatinine clearance ≤ 30 mL/min) should receive no more than 5 mg once daily. Patients with moderate hepatic impairment (Child-Pugh B) should 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, ciclosporin, 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 electrocardiogram 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 at 1.5%. In clinical trials, dry mouth was reported in 10.9% of patients receiving 5 mg and 27.6% receiving 10 mg, compared with 4.2% receiving placebo. Constipation was reported in 5.4% receiving 5 mg and 13.4% receiving 10 mg, compared with 2.9% receiving placebo.

Contraindications

Solifenacin Dr.Reddy's 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; patients undergoing haemodialysis; and severe hepatic impairment. Solifenacin Dr.Reddy's is also contraindicated in patients with severe hepatic impairment (Child-Pugh C).

Regulatory history

Solifenacin Dr.Reddy's received its first approval on 20 September 2021. Both the 5 mg and 10 mg film-coated tablet variants were first listed on the Australian Register of Therapeutic Goods on 29 September 2021.