Indication
Solurin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary frequency and urgency.
Dosage & Administration
The recommended dose of Solurin is 5 mg once daily. If necessary the dose may be increased to 10 mg once daily. Solifenacin Tablet should be taken orally and swallowed whole with liquids. It can be taken with or without food.
Dose adjustment for Hepatic and Renal impaired patients
Renal Impairment: No dosage adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance 30 ml/min) should be treated with caution and receive no more than 5 mg Solifenacin Tablet once daily.
Hepatic Impairment: No dosage adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment should be treated with caution and receive no more than 5 mg Solifenacin Tablet once daily.
Precautions
Other causes of frequent urination (heart failure or renal disease) should be assessed before treatment with Solifenacin. If urinary tract infection is present, an appropriate antibacterial therapy should be started. Solifenacin should be used with caution in patients with clinically significant bladder outflow obstruction at risk of urinary retention, gastrointestinal obstructive disorders, risk of decreased gastrointestinal motility, severe renal impairment (creatinine clearance 30 ml/min), moderate hepatic impairment, concomitant use of a strong CYP3A4 inhibitor, e.g. Ketoconazole
Use in special group
In Pregnancy: There are no adequate data from the use of Solifenacin Succinate in pregnant women. Caution should be exercised while prescribing Solifenacin to pregnant women. In lactating mother no data concerning the excretion of Solifenacin into breast milk are available. The use of Solifenacin is avoided in lactating mother.
In Pediatric Patient: Safety and efficacy of Solifenacin in children have not been established.
