Sofcare 5/Sofcare 10

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

Adults, including elderly 5 mg once daily. May be increased to 10 mg once daily. Severe renal (CrCl <30 mL/min) & hepatic (Child-Pugh score of 7-9) impairment, concomitant use w/ potent CYP3A4 inhibitors Max: 5 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ & at risk for urinary retention, severe GI condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma; undergoing hemodialysis. Severe hepatic impairment. Severe renal or moderate hepatic impairment coadministered w/ potent CYP3A4 inhibitor eg, ketoconazole.

Discontinue therapy if angioedema occurs; in patients who develop anaphylactic reactions. QT prolongation & Torsades de Pointes in patients w/ risk factors eg, pre-existing long QT syndrome & hypokalemia. Patients w/ clinically significant bladder outflow obstruction at risk of urinary retention; GI obstructive disorders; risk of decreased GI motility; hiatus hernia/gastro-esophageal reflux; autonomic neuropathy; neurogenic cause for detrusor overactivity. Assess other causes of frequent urination (heart failure or renal disease) before treatment; start antibacterial therapy if UTI is present. Concurrent use of medicinal products that can cause or exacerbate esophagitis eg, bisphosphonates. Concomitant use of potent CYP3A4 inhibitor eg, ketoconazole. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not to exceed >5 mg in patients w/ severe renal impairment (CrCl <30 mL/min) & moderate hepatic impairment (Child-Pugh score of 7-9). Pregnancy. Avoid use during breastfeeding. Not to be used in childn.

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

More pronounced therapeutic & undesirable effects w/ anticholinergics. Reduced therapeutic effect w/ cholinergic receptor agonists. Reduced effect of metoclopramide & cisapride. Increased AUC w/ potent CYP3A4 inhibitors eg, ketoconazole; ritonavir, nelfinavir, itraconazole. Concomitant use w/ 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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