Classes
DEA Class; Rx
Common Brand Names; Lotronex
- IBS Agents;
- Selective 5-HT3 Receptor Antagonists
Description
Oral selective serotonin 5-HT3 receptor antagonist
Approved only for adult females with severe diarrhea-predominant IBS (IBS-D) failing conventional therapy
Indications
Indicated for the treatment of severe, chronic, diarrhea-predominant irritable bowel syndrome (IBS) in women for whom conventional therapy has failed.
Indicated only for women with severe diarrhea-predominant IBS who have: chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of GI tract excluded, and not responded adequately to conventional therapy
Contraindications
Hypersensitivity
Rectal bleeding, history of chronic or severe current constipation
History of ischemic colitis, intestinal obstruction, stricture, toxic megacolon, GI perforation or adhesion, thrombophlebitis, diverticulitis, hypercoagulable state, history of or current Crohn’s disease or ulcerative colitis
Coadministration with apomorphine; combination reported to cause profound hypotension and loss of consciousness
Inability to comply with the Patient-Physician Agreement for Lotronex
Severe hepatic impairment
Impaired intestinal circulation
Concomitant administration with fluvoxamine
Thrombocytopenia
Adverse Effects
- Constipation (29%)
- Abdominal pain (7%)
- Nausea (6%)
- Headache (≥3%)
- GI discomfort and pain (5%)
- Fatigue (≥3%)
- Gastroenteritis (>3%)
- Abdominal distention (2%)
- Flatulence (1-3%)
- Regurgitation and reflux (2%)
- Abdominal distension (2%)
- Hemorrhoids (2%)
- Urinary tract infection (≥3%)
- Muscle spasm (≥3%)
- Cough (≥3%)
- Nasopharyngitis (≥3%)
Warnings
Discontinue if inadequate control after 4 weeks of q12hr dosing
Use with caution in breast-feeding women
Use caution in mild-to-moderate hepatic impairment
Withdrawn from U.S. market in Nov. 2000 due to cases of severe ischemic colitis, obstructed or ruptured bowel, and death; reinstated in June 2002 on a limited basis
Pregnancy and Lactation
The available data with use in pregnant women are insufficient to draw conclusions about any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
There are no data regarding presence of drug in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
2 mg/day PO.
2 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Alosetron hydrochloride
tablet
- 0.5mg
- 1mg
