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Solifenacin

SOLIFENACIN

Manufacturer: Zydus Pharmaceuticals USA Inc.

Score: 141.0

Quick Summary

Solifenacin is a muscarinic receptor antagonist used for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended oral dose is 5 mg once daily, which can be increased to 10 mg once daily if well tolerated. However, the dose should not exceed 5 mg once daily in patients with severe renal impairment, moderate hepatic impairment, or when concomitantly used with strong CYP3A4 inhibitors. Solifenacin is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and hypersensitivity to the drug or its components. The most common adverse reactions include dry mouth, constipation, urinary tract infection, and blurred vision.

Key Clinical Findings and Indications

  • Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
  • Muscarinic receptor antagonist

Important Safety Information

Warning

Do not exceed the 5 mg dose of solifenacin succinate in patients with severe renal impairment, moderate hepatic impairment, or when concomitantly used with strong CYP3A4 inhibitors

Contraindications

  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow-angle glaucoma
  • Hypersensitivity to the drug or its components

Adverse Reactions

  • Dry mouth
  • Constipation
  • Urinary tract infection
  • Blurred vision

Dosing Recommendations

General Guidance

Do not exceed the 5 mg dose of solifenacin succinate in patients with severe renal impairment, moderate hepatic impairment, or when concomitantly used with strong CYP3A4 inhibitors

Overactive bladder

Adult Dose

5 mg once daily, which can be increased to 10 mg once daily if well tolerated

Pediatric Dose

Special Population Considerations

Pregnancy

  • 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

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of solifenacin succinate tablets have not been established in pediatric patients

Geriatric Use

  • Similar safety and effectiveness were observed between geriatric patients and younger adult patients treated with solifenacin succinate

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