(2) Important Safety Information
Indication: Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with an acute ingestion or from repeated supratherapeutic ingestion.
Acetadote is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine.
Serious acute hypersensitivity reactions including rash, hypotension, wheezing, and/or shortness of breath have been observed in patients receiving intravenous acetylcysteine administration and occurred soon after initiation of infusion. Acetadote should be used with caution in patients with asthma or where there is a history of bronchospasm. Immediately discontinue infusion if a serious reaction occurs and initiate appropriate treatment. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction.
In the literature, the most frequently reported adverse reactions attributed to intravenous acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions have been reported to be between 0.2% and 21%, and they most commonly occur during the initial loading dose of acetylcysteine.