Astellas Pharma


Concise Prescribing Info
Solifenacin succinate
Symptomatic treatment of urge incontinence &/or increased urinary frequency & urgency in patients w/ overactive bladder syndrome.
Dosage/Direction for Use
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, do not chew/crush.
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.
Special Precautions
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. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ potent CYP3A4 inhibitor eg, ketoconazole; drugs causing or exacerbating oesophagitis eg, bisphosphonates; drugs prolonging QT interval. May affect ability to drive & use machines. Severe renal impairment, moderate hepatic impairment. Pregnancy. Avoid use during lactation. Not to be used in childn.
Adverse Reactions
Dry mouth. Blurred vision; constipation, nausea, dyspepsia, abdominal pain.
Drug Interactions
Reduced therapeutic effect w/ cholinergic-receptor agonists. Reduced effect of drugs stimulating GI tract motility eg, metoclopramide, cisapride. Increased AUC w/ ketoconazole. CYP3A4 substrates w/ higher affinity eg, verapamil, diltiazem; CYP3A4 inducers eg, rifampicin, phenytoin, carbamazepine; drugs prolonging QT/QTc interval eg, erythromycin, quinidine, procainamide, disopyramide, sotalol, amiodarone, cisapride, fluconazole, amitriptyline, haloperidol, chlorpromazine, thioridazine, pimozide, droperidol.
ATC Classification
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
Vesicare FC tab 5 mg
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