Urgiso Tablets (Solifenacin Succinate)

• Composition :
  Each tablet contains 5 mg of solifenacin succinate.
• Indications :
  For overactive bladder with urge urinary incontinence urgency and urinary frequency.
• Pharmacodynamics :
  Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle and stimulation of salivary secretion. The binding of acetylcholine to these receptors, particularly M3, plays a critical role in the contraction of smooth muscle. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of micturition, urgency and incontinence episodes.
• Dosage and administration :
  5 mg tablet taken once daily, and if well tolerated may be increased to 10 mg once daily. It can be administered with or without food.
• Contraindications :
  Urinary retention. Gastric retention. Uncontrolled narrow-angle glaucoma. Hypersensitivity to this product or any of its components.
• Precautions and warnings :
  Angioedema and Anaphylactic Reactions: Promptly discontinue Urgiso and provide appropriate therapy. Urinary Retention: Urgiso is not recommended for use in patients with clinically significant bladder outlet obstruction. Gastrointestinal Disorders: Urgiso is not recommended for use in patients with decreased gastrointestinal motility. Central Nervous System Effects: Somnolence has been reported with Urgiso. Advise patients not to drive or operate heavy machinery until they know how Urgiso affects them. Controlled Narrow-Angle Glaucoma: Use Urgiso with caution in patients being treated for narrow-angle glaucoma. QT Prolongation in Patients at High Risk of QT Prolongation: Urgiso is not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval.
• Use in pregnancy, lactation & pediatrics :
  There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcome. There is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. The safety and effectiveness of Urgiso tablets have not been established in pediatric patients.
• Drug interactions :
  Solifenacin had no significant effect on the pharmacokinetics of digoxin, warfarin in healthy subjects.It is recommended not to exceed a 5 mg daily dose of Solifenacin when administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors
• Adverse reactions :
  The most common adverse reactions were dry mouth, and constipation and urinary tract infection, and blurred vision.
• Therapy Area :
  Urologicals