Properties
What is it?
International Nonproprietary Name - Solifenacin Succinate 5mg and 10mg film-coated tablets Therapeutic indications Soliget (Solifenacin Succinate) is used to treat overactive bladder, characterized by symptoms of urinary incontinence, urgency, frequency, or nocturia. Dosage and administration Soliget (Solifenacin Succinate) tablets should be taken whole, swallowed with water. They can be taken with or without food. Adults The recommended dose of Soliget (Solifenacin Succinate) is 5mg once daily. If necessary, the dose may be increased to 10mg once daily. Patients with renal impairment Patients with mild to moderate renal impairment (CLcr > 30 mL/min) do not require dose adjustment. In cases of severe renal impairment (CLcr < 30 mL/min), patients should be treated with caution, and the dose of Solifenacin Succinate should not exceed 5mg daily. Patients with hepatic impairment Patients with mild hepatic impairment do not require dose adjustment. In patients with moderate hepatic impairment (Child-Pugh score 7-9), Solifenacin Succinate should be administered with caution, not exceeding 5mg once daily. Strong CYP3A4 inhibitors: When treated with medications such as ketoconazole and ritonavir, which are strong inhibitors of the cytochrome P450 isoenzyme CYP3A4, the recommended maximum dose of Soliget is 5mg. Side effects Very common: dry mouth Common: constipation, nausea, dyspeptic events, abdominal pain, blurred vision. Uncommon: gastro-esophageal reflux, dry throat, urinary tract infections, cystitis, somnolence, dysgeusia, dry eyes, fatigue, peripheral edema, dry nose, dry skin, difficulty in micturition. Rare: intestinal obstruction, fecal impaction, urinary retention. Contraindications Solifenacin Succinate is contraindicated in patients with: - Hypersensitivity to the active substance or any of the excipients. - Urinary retention. - Gastric stasis. - Angle-closure glaucoma. - Neuromuscular transmission disorders (myasthenia gravis). - Patients undergoing hemodialysis. - Patients with severe hepatic and renal impairment. Solifenacin Succinate is not indicated in children as there are no established data on the safety and efficacy of the preparation.