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Human experience: There is limited clinical experience with overdose of PENTASA which does not indicate renal or hepatic toxicity. Since PENTASA is an aminosalicylate, symptoms of salicylate toxicity such as acid-base balance disorder, hyperventilation, pulmonary edema, vomiting, dehydration and hypoglycaemia may occur. Symptoms of salicylate overdosage are well described in the literature.
There have been reports of patients taking daily doses of 8 grams for a month without any adverse events.
There is no specific antidote and the management of overdose is supportive and symptomatic. The treatment at the hospital includes close monitoring of renal function.
Acute experience in animals: PR Tablet and PR Granules: Single oral doses of mesalazine up to 5 g/kg in pigs or a single intravenous dose of mesalazine at 920 mg/kg in rats were not lethal.
