For all questions concerning adverse events associated with the use of this product or for inquiries concerning all of our products, please contact Cumberland Pharmaceuticals by phone at (877) 484-2700 or by email at acetadote@cumberlandpharma.com.
For specific treatment information regarding the clinical management of acetaminophen overdose, please contact your regional poison center at (800) 222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at (800) 525-6115.
Cumberland Pharmaceuticals offers a toll-free Customer Service number for orders and other inquiries concerning Acetadote and our other products. Call (877) 274-7200.
Cumberland Pharmaceuticals Inc.
2525 West End Avenue, Suite 950
Nashville, TN 37203
Phone: (615) 255-0068
Fax: (615) 255-0094
info@cumberlandpharma.com
www.cumberlandpharma.com
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.