OVERDOSAGE
Two cases of pediatric overdosage have been reported. A 3-year-old male who ingested 2 grams of Asacol tablets was treated with ipecac and activated charcoal; no adverse events occurred. Another 3-year-old male, approximately 16 kg, ingested an unknown amount of a maximum of 24 grams of Asacol crushed in solution (i.e., uncoated mesalamine); he was treated with orange juice and activated charcoal, and experienced no adverse events. In dogs, single doses of 6 grams of delayed-release Asacol tablets resulted in renal papillary necrosis but were not fatal. This was approximately 12.5 times the recommended human dose (based on a dose of 2.4 g/day in a 50 kg person). Single oral doses of uncoated mesalamine in mice and rats of 5000 mg/kg and 4595 mg/kg, respectively, or of 3000 mg/kg in cynomolgus monkeys, caused significant lethality.
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