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Tolterodine Tartrate

TOLTERODINE TARTRATE

Manufacturer: Slate Run Pharmaceuticals, LLC

Score: 141.0

Quick Summary

Tolterodine Tartrate is a muscarinic receptor antagonist used for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The recommended dose is 4 mg once daily, with possible dose reduction to 2 mg daily based on individual response and tolerability. Contraindications include urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, as well as known hypersensitivity to the drug or its ingredients. Adverse reactions may include dry mouth, headache, constipation, and abdominal pain.

Key Clinical Findings and Indications

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

Important Safety Information

Warning

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

Contraindications

  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow-angle glaucoma
  • Known hypersensitivity to the drug or its ingredients

Adverse Reactions

  • Dry mouth
  • Headache
  • Constipation
  • Abdominal pain

Dosing Recommendations

General Guidance

Dose reduction to 2 mg daily may be necessary in patients with mild to moderate hepatic impairment, severe renal impairment, or those taking potent CYP3A4 inhibitors

Overactive bladder

Adult Dose

4 mg once daily

Pediatric Dose

Not recommended for use in pediatric patients

Special Population Considerations

Pregnancy

  • No available data on use in pregnant women
  • Animal studies showed no adverse effects at doses up to 9-12 times the clinical exposure

Nursing Mothers

  • No information on presence in human milk
  • Caution advised due to potential for adverse effects in the breastfed infant

Pediatric Use

  • Not recommended for use in pediatric patients
  • Efficacy not established in clinical studies

Geriatric Use

  • No overall differences in safety observed between older and younger patients
  • Dose adjustment not recommended based on age alone