ACETADOTE is an ethical pharamaceutical that has been approved and is regulated by the Food and Drug Administration (FDA). ACETADOTE can be obtained only by prescription from a licensed healthcare provider after diligent disclosure by the healthcare provider.
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Important Safety Information
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.
Indications and Usage
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.