Sofcare 5

Solifenacin succinate

Symptomatic treatment of urge incontinence &/or increased urinary frequency & urgency in patients w/ overactive bladder syndrome.

Adult including elderly 5 mg once daily, may be increased to 10 mg once daily. Severe renal impairment (CrCl ≤30 mL/min) & moderate hepatic impairment (Child-Pugh 7-9) Max: 5 mg once daily.

May be taken with or without food: Swallow whole w/ liqd.

Hypersensitivity. Urinary retention, severe GI condition including toxic megacolon, myasthenia gravis, narrow-angle glaucoma. Concomitant use w/ potent CYP3A4 inhibitor eg, ketoconazole. Patients undergoing haemodialysis. Severe renal & moderate to severe hepatic impairment.

Discontinue use if anaphylactic reactions develop & angioedema occurs. Clinically significant bladder outflow obstruction at risk of urinary retention; GI obstructive disorders; risk of decreased GI motility; hiatus hernia/GERD; autonomic neuropathy. Patients w/ neurogenic cause for detrusor overactivity; known risk factors for QT prolongation ie, history of QT prolongation, long QT syndrome, hypokalaemia, bradycardia; relevant pre-existing cardiac diseases ie, myocardial ischaemia, arrhythmia, CHF. May cause serious allergic-type reactions due to Na metabisulfite. Concomitant use w/ potent CYP3A4 inhibitor eg, ketoconazole; medicinal products causing or exacerbating oesophagitis eg, bisphosphonates. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Severe renal (CrCl ≤30 mL/min) & moderate hepatic (Child-Pugh score 7-9) impairment. Pregnancy. Avoid use during lactation. Not to be used in childn.

Dry mouth. Blurred vision; constipation, nausea, dyspepsia, abdominal pain.

Reduced therapeutic effect w/ cholinergic-receptor agonists. Reduced effect of drugs stimulating GI tract motility eg, metoclopramide, cisapride. Increased AUC w/ ketoconazole, ritonavir, nelfinavir, itraconazole. CYP3A4 substrates w/ higher affinity eg, verapamil, diltiazem; CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine.

Drugs for Bladder & Prostate Disorders

G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.

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