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Oxybutynin Chloride Extended Release

OXYBUTYNIN CHLORIDE

Manufacturer: AvKARE

Score: 145.0

Quick Summary

Oxybutynin Chloride Extended Release is a muscarinic antagonist used to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It is also used in pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition. The drug has a once-daily dosing regimen and is available in 5, 10, and 15 mg tablets. Important safety considerations include contraindications in patients with urinary retention, gastric retention, and uncontrolled narrow-angle glaucoma, as well as potential adverse reactions such as dry mouth, constipation, and dizziness.

Key Clinical Findings and Indications

  • Overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency
  • Detrusor overactivity associated with a neurological condition in pediatric patients aged 6 years and older

Important Safety Information

Warning

Oxybutynin Chloride Extended Release is contraindicated in patients with urinary retention, gastric retention, and uncontrolled narrow-angle glaucoma

Contraindications

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

Adverse Reactions

  • Dry mouth
  • Constipation
  • Diarrhea
  • Headache
  • Somnolence
  • Dizziness

Dosing Recommendations

General Guidance

Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability

Overactive bladder

Adult Dose

5 or 10 mg once daily, with a maximum dose of 30 mg/day

Pediatric Dose

5 mg once daily, with a maximum dose of 20 mg/day

Special Population Considerations

Pregnancy

  • Oxybutynin Chloride Extended Release should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus

Nursing Mothers

  • Caution should be exercised when Oxybutynin Chloride Extended Release is administered to a nursing woman

Pediatric Use

  • Oxybutynin Chloride Extended Release is not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6

Geriatric Use

  • The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar

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