Sofenacin Tablet

Brand Name: Sofenacin 10mg Tablet
                      Sofenacin  5mg Tablet

Active Ingredient: Solifenacin succinate

When is Sofenacin Tablet prescribed for?

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

How should you take Sofenacin Tablet?

The recommended dose of Sofenacin is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased
to 10 mg once daily. 
• Sofenacin should be taken with liquids and swallowed whole.
• Sofenacin can be administered with or without food.
• Dose Adjustment in Renal Impairment.
- For patients with severe renal impairment (CLcr < 30 mL/min).
- A daily dose of Sofenacin greater than 5 mg is not recommended. 
• Dose Adjustment in Hepatic Impairment.
- For patients with moderate hepatic impairment (Child-Pugh B).
- A daily dose of Sofenacin greater than 5 mg is not recommended.
- Use of Sofenacin in patients with severe hepatic impairment (Child-Pugh C) is not recommended.
• Dose Adjustment CYP3A4 Inhibitors.
- When administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors, a daily dose of Sofenacin greater than 5 mg is not recommended.

When you should not take Sofenacin Tablet?

Sofenacin is contraindicated in patients with:

  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow-angle glaucoma
  • Hypersensitivity to the drug substance or other components of the product.

Special warning and precautions on using Sofenacin Tablet:              

  • Bladder Outflow Obstruction
    Sofenacin, like other anticholinergic drugs, should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. 
  • Gastrointestinal Obstructive Disorders and Decreased GI Motility.
    Sofenacin, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility.
  • Controlled Narrow-Angle Glaucoma.
    Sofenacin should be used with caution in patients being treated for narrow-angle glaucoma. 
  • Reduced Renal Function.
    Sofenacin should be used with caution in patients with reduced renal function.
    Doses of Sofenacin greater than 5 mg are not recommended in patients with severe renal impairment (CLcr < 30 mL/min).

Possible Drug interaction with Sofenacin Tablet:

Do not exceed a 5 mg daily dose of Sofenacin when administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors.

Special information if you are pregnant or breastfeeding

Pregnancy

  • Pregnancy Category C: Because animal reproduction studies are not always predictive of human response.
  • Sofenacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • The effect of Sofenacin on labour and delivery in humans has not been studied.

Lactation

  • It is not known whether solifenacin is excreted in human milk. Because many drugs are excreted in human milk, Sofenacin should not be administered during nursing.
  • A decision should be made whether to discontinue nursing or to discontinue Sofenacin in nursing mothers.

Possible Side effects with Sofenacin Tablet:

  • Blurred vision: Use caution while driving or doing dangerous activities until you know how Sofenacin affects you.
  • Dry mouth.
  • Constipation
  • Heat prostration (due to decreased sweating), can occur when drugs such as Sofenacin are used in a hot environment.