Acetaminophen is the most common substance involved in drug ingestions reported to U.S. poison control centers.1
Based on data from the American Association of Poison Control Centers (AAPCC), acetaminophen was involved in approximately 120,000 poisoning exposures in the United States in 2007.1 Of these reported exposures, only about 30,000 were treated.1
Acetaminophen can be found in >600 Rx and OTC products.2 When ingested in quantities of 150 mg/kg or more, acetaminophen can lead to hepatic toxicity and death.3
The only FDA-approved I.V. acetylcysteine for acetaminophen overdose.
ACETADOTE, introduced in the United States in 2004 and currently used in more than 3,000 hospitals across the U.S., is a safe and efficacious treatment for acetaminophen overdose when administered within 8-10 hours post-ingestion. With a 3-dose, 21-hour I.V. NAC infusion, ACETADOTE is the shortest FDA-approved treatment regimen.
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.
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.
The most frequently reported adverse reactions attributed to I.V. 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.
1. Bronstein AC, Spyker DA, Cantilena JR, et al. 2007 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 25th Annual Report. Clin Tox 2008; 46;10:927-1057.
2. FDA launches consumer campaign on safe use of OTC pain products [press release]. Rockville, MD: US Food and Drug Administration; January 22, 2004.
3. ACETADOTE Package Insert.