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warnings
WARNINGS The flavor packs are for use with the accompanying 4 liter bottle. No additional ingredients, e.g., flavorings, should be added to the solution. TRILYTE with flavor packs should be used with caution in patients with severe ulcerative colitis. Use of TRILYTE with flavor packs in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.
ADVERSE REACTIONS Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of TRILYTE with flavor packs. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and "butterfly-like" infiltrate on chest X-ray after vomiting and aspirating PEG.