Contraindications:Lotronex™ is contraindicated in patients with:Crohn’s disease, ulcerative colitis, or diverticulitis A history of ischemic colitis, compromised intestinal circulation, thrombophlebitis and other clotting disorders A histtory of severe or chronic constipation with subsequent problems/complications A history of intestinal obstruction, toxic megacolon, stricture, and gastrointestinal adhesions or perforation.Side Effects:GI: Acute ischemic colitis, constipation, nausea, GI discomfort and pain, abdominal discomfort and pain, GI gaseous symptoms, viral gastrointestinalinfections, dyspeptic symptoms, abdominal distension, hemorrhoids. Otolaryngology: Throat and tonsil discomfort and pain, allergic rhinitis, bacterial ear, nose, andthroat infections. Cardiovascular: Hypertension. CNS: Sleep disorders. Psychiatry: Depressive disorders.Risk of Side EffectsIschemic colitis has been reported in patients receiving Lotronex™ in clinical trials as well as during marketed use of the drug. In IBS clinical trials, the cumulativeincidence of ischemic colitis in women receiving Lotronex™ was 2 per 1,000 patients (95% confidence interval 1 to 3) over 3 months and was 3 per 1,000 patients(95% confidence interval 1 to 4) over 6 months. Patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patientstaking Lotronex™ for longer than 6 months.Infrequent adverse events, those occurring on one or more occasion in 1/100 to 1/1000 patients include; rare adverse events are those occurring on one or moreoccasion in fewer than 1/1000 patients. These events include:Blood and Lymphatic: Rare:Quantitative red cell or hemoglobin defects, hemorrhage, and lymphatic signs and symptoms.Cardiovascular: Infrequent:Tachyarrhythmias. Rare: Arrhythmias, increased blood pressure, and extrasystoles.Drug Interaction, Overdose, and Trauma: Rare:Contusions and hematomas.Ear, Nose, and Throat: Rare:Ear, nose, and throat infections; viral ear, nose, and throat infections; and laryngitis.Endocrine and Metabolic: Rare:Disorders of calcium and phosphate metabolism, hyperglycemia, hypothalamus/pituitary hypofunction, hypoglycemia, and fluiddisturbances.
Eye: Rare:Light sensitivity of eyes.Gastrointestinal: Infrequent:Hyposalivation, dyspeptic symptoms, gastrointestinal spasms, ischemic colitis and gastrointestinal lesions. Rare:Abnormal tenderness,colitis, gastrointestinal signs and symptoms, proctitis, diverticulitis, positive fecal occult blood, hyperacidity, decreased gastrointestinal motility and ileus,gastrointestinal obstructions, oral symptoms, gastrointestinal intussusception, gastritis, gastroduodenitis, gastroenteritis, and ulcerative colitis.Hepatobiliary Tract and Pancreas: Rare:Abnormal bilirubin levels and cholecystitis.Lower Respiratory: Infrequent:Breathing disorders. Rare:Viral respiratory infections.