Solitor 5

Solitor 5

solifenacin

Manufacturer:

Torrent Pharmaceuticals

Distributor:

Torrent
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 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 use w/ ketoconazole or other potent CYP3A4 inhibitor eg, ritonavir, nelfinavir, itraconazole Limit max dose to 5 mg.
Administration
May be taken with or without food: Swallow whole w/ liqd.
Contraindications
Hypersensitivity. Patients w/ urinary or gastric retention, & uncontrolled narrow-angle glaucoma.
Special Precautions
Discontinue use & take appropriate therapy &/or measures if anaphylactic reactions develop; angioedema occurs. Assess other causes of frequent urination (heart failure or renal disease) before treatment. Use w/ caution in patients w/ clinically significant bladder outflow obstruction at risk of urinary retention; GI obstructive disorders & decreased GI motility; reduced renal & hepatic function; hiatus hernia/gastro-esophageal reflux &/or who are concurrently taking medicinal products (eg, bisphosphonates) that can cause or exacerbate esophagitis; autonomic neuropathy; myasthenia gravis. Reports of QT prolongation & torsade de pointes in patients w/ risk factors eg, preexisting long QT syndrome & hypokalemia. May cause blurred vision &, uncommonly, somnolence & fatigue which may negatively affect ability to drive & use machines. Use in pregnancy only if potential benefit justifies potential fetal risk. Not to be administered during nursing. Not to be used in childn.
Adverse Reactions
Dry mouth, nausea. Blurred vision; constipation, dyspepsia, abdominal pain.
Drug Interactions
Increased AUC w/ ketoconazole (potent CYP3A4 inhibitor).
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD08 - solifenacin ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Solitor 5 FC tab 5 mg
Packing/Price
30's (P1,440/box)