There is no published information available regarding overdosage with RESCULA 0.15%. The risk of adverse effects due to accidental oral ingestion is very low since the amount of active ingredient in each bottle is limited (7.5 mg in a 5 mL vial). Accidental ingestion of a vial by a child with 30 kg body weight will amount to 0.25 mg/kg body weight.

If overdosage does occur, treatment should be symptomatic.

In cynomolgus monkeys administered Rescula for twelve months at 150 mg/eye/day (equal to the human dose), one of ten animals exhibited increased pigmentation of the iris. The incidence did not change when the administered dose was increased to 300 mg/eye/day (twice the human dose) for an additional six months.

Known hypersensitivity to unoprostone isopropyl, benzalkonium chloride or any other ingredients in this product.

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