Darifenacin

DARIFENACIN HYDROBROMIDE

Manufacturer: POLYGEN PHARMACEUTICALS INC.

Score: 145.0

Quick Summary

Darifenacin is a muscarinic antagonist used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The recommended starting dose is 7.5 mg once daily, which can be increased to 15 mg once daily based on individual response. Darifenacin is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. The most frequently reported adverse reactions are constipation, dry mouth, headache, dyspepsia, nausea, urinary tract infection, accidental injury, and flu symptoms. Special population considerations include pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
Muscarinic antagonist

Important Safety Information

Warning

Darifenacin is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma

Contraindications

Urinary retention
Gastric retention
Uncontrolled narrow-angle glaucoma

Adverse Reactions

Constipation
Dry mouth
Headache
Dyspepsia
Nausea
Urinary tract infection
Accidental injury
Flu symptoms

Dosing Recommendations

General Guidance

The daily dose of darifenacin should not exceed 7.5 mg in patients with moderate hepatic impairment or when co-administered with potent CYP3A4 inhibitors

Overactive bladder

Adult Dose

7.5 mg once daily, increased to 15 mg once daily as needed

Pediatric Dose

Special Population Considerations

Pregnancy

Darifenacin should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus
No studies of darifenacin in pregnant women

Nursing Mothers

Caution should be exercised before darifenacin is administered to a nursing woman
Darifenacin is excreted into the milk of rats

Pediatric Use

The safety and effectiveness of darifenacin in pediatric patients have not been established

Geriatric Use

No overall differences in safety or efficacy were observed between patients over 65 years and younger patients
No dose adjustment is recommended for elderly patients

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