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The total volume administered should be adjusted for patients less than 40 kg (88 lbs) and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed.
Diluent: Acetadote is compatible with 5% Dextrose (D5W), ½ Normal Saline, and Water for Injection.
NOTE: Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.
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Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury.
For maximal protection against hepatic injury, administer Acetadote within 8 hours post-ingestion.
Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post-ingestion of acetaminophen yields limited efficacy.
Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously.
Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death.
In the literature, the most frequently reported adverse reactions attributed to IV acetylcysteine administration were rash, urticaria and pruritus. The frequency of adverse reactions has been reported to be between 0.2% and 20.8%, and they most commonly occur during the initial loading dose of acetylcysteine.