Generic Name and Formulations:
Alosetron (as HCl) 0.5mg, 1mg; tabs.
Prometheus Labs, Inc.
Indications for LOTRONEX:
For women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have chronic IBS symptoms (generally lasting 6 months or longer) and have had anatomic or biochemical abnormalities of the GI tract excluded, and not responded adequately to conventional therapy. Restricted to patients for whom the benefit-to-risk balance is most favorable.
Initially 0.5mg twice daily. May increase to 1mg twice daily after 4 weeks if starting dose is tolerated but inadequate. Discontinue if inadequate control of symptoms after 4 weeks of treatment at 1mg twice daily. If constipation occurs, discontinue until constipation resolves, then restart at 0.5mg once daily. If constipation recurs, discontinue immediately.
Constipation. Intestinal obstruction, stricture. Toxic megacolon. GI perforation, and/or adhesions. Ischemic colitis. Impaired intestinal circulation. Thrombophlebitis. Hypercoagulable state. Crohn's disease. Ulcerative colitis. Diverticulitis. Severe hepatic impairment. Concomitant fluvoxamine.
Serious gastrointestinal adverse reactions.
Discontinue immediately if constipation or symptoms of ischemic colitis develop; may resume if constipation resolves but not if ischemic colitis occurs. Hepatic impairment. Elderly. Debilitated. Pregnancy (Cat.B). Nursing mothers.
5-HT3 receptor antagonist.
See Contraindications. Avoid concomitant moderate CYP1A2 inhibitors (eg, quinolones, cimetidine). May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, telithromycin, protease inhibitors, voriconazole, itraconazole). Caution with drugs that decrease GI motility.
Constipation, abdominal discomfort/pain, nausea, GI discomfort/pain; ischemic colitis, complications of constipation (may be serious).
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