Actonel

[Risedronate]

Overdosage & Contraindications
CONTRAINDICATIONS

Hypocalcemia (see PRECAUTIONS, General) Known hypersensitivity to any component of this product

Inability to stand or sit upright for at least 30 minutes

OVERDOSAGE

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Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. Milk or antacids containing calcium should be given to bind ACTONEL and reduce absorption of the drug.

In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia.

Lethality after single oral doses was seen in female rats at 903 mg/ kg and male rats at 1703 mg/ kg. The minimum lethal dose in mice and rabbits was 4000 mg/ kg and 1000 mg/ kg. These values represent 320 to 620 times the 30-mg human dose based on surface area (mg/ m 2 ).