Solifenacin Succinate

Solifenacin succinate is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

• 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. (
  
  
  
  
  
  2.1)
  
  
  
  
• Do not exceed the 5 mg dose of solifenacin succinate in patients with:
  
  
  
  
  
  
  • Severe renal impairment creatinine clearance < 30 mL/min/1.73 m
    
    
    
    
    
    ². (
    
    
    
    
    
    2.2,
    
    
    
    
    
    8.6)
    
    
    
    
    
    
  • Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate is not recommended in patients with severe hepatic impairment (Child-Pugh C). (
    
    
    
    
    
    2.3,
    
    
    
    
    
    8.7)
    
    
    
    
    
    
  • Concomitant use of strong CYP3A4 inhibitors. (
    
    
    
    
    
    2.4,
    
    
    
    
    
    7.1)
    
    
    
    
    
    

The 5 mg tablets are light yellow, round, film coated tablets debossed with 'SG' on one side and '427' on other side.

The 10 mg tablets are light pink, round, film coated tablets debossed with 'SG' on one side and '428' on other side.

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 outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring

In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

• Angioedema and Anaphylactic Reactions
  : Promptly discontinue solifenacin succinate and provide appropriate therapy. (
  
  
  
  
  
  5.1)
  
  
  
  
• Urinary Retention
  : Solifenacin succinate is not recommended for use in patients with clinically significant bladder outlet obstruction. (
  
  
  
  
  
  5.2)
  
  
  
  
• Gastrointestinal Disorders
  : Solifenacin succinate is not recommended for use in patients with decreased gastrointestinal motility. (
  
  
  
  
  
  5.3)
  
  
  
  
• Central Nervous System Effects
  : Somnolence has been reported with solifenacin succinate. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them. (
  
  
  
  
  
  5.4)
  
  
  
  
• Controlled Narrow-Angle Glaucoma
  : Use solifenacin succinate with caution in patients being treated for narrow-angle glaucoma. (
  
  
  
  
  
  5.5)
  
  
  
  
• QT Prolongation in Patients at High Risk of QT Prolongation
  : Solifenacin succinate 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. (
  
  
  
  
  
  5.6)