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Alosetron Hydrochloride

ALOSETRON HYDROCHLORIDE

Manufacturer: Actavis Pharma, Inc.

Score: 144.0

Quick Summary

Alosetron Hydrochloride is a potent and selective 5-HT3 receptor antagonist used for the treatment of severe diarrhea-predominant irritable bowel syndrome (IBS) in women who have not responded adequately to conventional therapy. The drug has a boxed warning for serious gastrointestinal adverse reactions, including ischemic colitis and complications of constipation. It is contraindicated in patients with constipation, history of severe bowel or hepatic disorders, and concomitant use of fluvoxamine. The initial dose is 0.5 mg twice daily, which may be increased to 1 mg twice daily after 4 weeks if well tolerated and if IBS symptoms are not adequately controlled.

Key Clinical Findings and Indications

  • Treatment of severe diarrhea-predominant irritable bowel syndrome (IBS) in women
  • Reduction of pain and exaggerated motor responses in patients with IBS
  • Increase in colonic transit time without affecting orocecal transit time

Important Safety Information

Warning

Serious gastrointestinal adverse reactions, including ischemic colitis and complications of constipation

Contraindications

  • Constipation
  • History of chronic or severe constipation or sequelae from constipation
  • History of severe bowel or hepatic disorders
  • Concomitant use of fluvoxamine

Adverse Reactions

  • Constipation
  • Abdominal discomfort and pain
  • Nausea
  • Gastrointestinal discomfort and pain
  • Ischemic colitis

Dosing Recommendations

General Guidance

Discontinue in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice daily

Severe diarrhea-predominant IBS

Adult Dose

0.5 mg twice daily, may be increased to 1 mg twice daily after 4 weeks if well tolerated and if IBS symptoms are not adequately controlled

Pediatric Dose

Special Population Considerations

Pregnancy

  • No adequate and well-controlled studies in pregnant women
  • Use with caution and only if benefits outweigh risks

Nursing Mothers

  • No data regarding the presence of alosetron in human milk
  • Monitor infants exposed to alosetron through breast milk for severe constipation and blood in stools

Pediatric Use

  • Safety and effectiveness not established in pediatric patients
  • Not recommended for use in pediatric population due to risk of serious complications of constipation and ischemic colitis

Geriatric Use

  • Elderly patients may be at greater risk for complications of constipation
  • Use with caution and monitor for constipation and other adverse reactions

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