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warnings
WARNINGS PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution flavor packs are for use only in combination with the contents of the accompanying 4 liter container. No additional ingredients, e.g., flavorings, should be added to the solution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution should be used with caution in patients with severe ulcerative colitis. Use of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 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 one child and hypokalemia has been reported in three children.
ADVERSE REACTIONS Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. 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.