Utocare

Utocare

solifenacin

Manufacturer:

DongKoo

Distributor:

SB Pharma
Concise Prescribing Info
Contents
Solifenacin succinate
Indications/Uses
Symptomatic treatment of urge incontinence &/or increased urinary frequency & urgency in patients w/ overactive bladder syndrome.
Dosage/Direction for Use
Adult, including the elderly 5 mg once daily, may be increased to 10 mg once daily if needed. Patient w/ severe renal impairment (CrCl ≤30 mL/min) Max: 5 mg once daily. Patient w/ moderate hepatic impairment (Child-Pugh score 7-9) Max: 5 mg once daily. Concomitant w/ potent CYP3A4 inhibitor Max: 5 mg once daily.
Administration
May be taken with or without food: Swallow whole w/ liqd.
Contraindications
Hypersensitivity. Patients w/ urinary retention, severe GI condition (including toxic megacolon), myasthenia gravis or narrow-angle glaucoma & in patients at risk for these conditions. Patients undergoing haemodialysis; patients w/ severe hepatic impairment; patients w/ severe renal impairment or moderate hepatic impairment & who are on treatment w/ a potent CYP3A4 inhibitor eg, ketoconazole.
Special Precautions
Assess other causes of frequent urination (heart failure or renal disease) before treatment. Start an appropriate antibacterial therapy if UTI is present. Caution in patients w/ clinically significant bladder outflow obstruction at risk of urinary retention; GI obstructive disorders; risk of decreased GI motility; severe renal impairment (CrCl ≤30 mL/min); moderate hepatic impairment (Child-Pugh score 7-9); concomitant use of a potent CYP3A4 inhibitor eg, ketoconazole; hiatus hernia/gastro-oesophageal reflux &/or who are concurrently taking medicinal products (eg, bisphosphonates) that can cause or exacerbate oesophagitis; autonomic neuropathy. Reports of QT prolongation & Torsade de Pointes in patients w/ risk factors eg, pre-existing long QT syndrome & hypokalaemia; angioedema w/ airway obstruction; anaphylactic reactions. Safety & efficacy have not been established in patients w/ neurogenic cause for detrusor overactivity. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Do not use in childn.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Utocare FC tab 10 mg
Packing/Price
3 × 10's
Form
Utocare FC tab 5 mg
Packing/Price
3 × 10's
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