News & Events

Recent Announcements:

Mar 22, 2011
New Acetadote® Formulation Now Available in the U.S.

Jan 13, 2011
Cumberland Pharmaceuticals Receives FDA Approval For New Formulation Of Acetadote®

Dec 22, 2010
FDA Issues Complete Response Letter Regarding Acetadote® Supplemental New Drug Application for Acute Liver Failure

Oct 14, 2010
Cumberland Pharmaceuticals and Phebra PTY Ltd. Announce the Launch of Acetadote® in Australia

Aug 20, 2010
Cumberland Pharmaceuticals Announces Extension of FDA Review of Acetadote® Supplemental New Drug Application

May 11, 2010
Acetadote® Approved in Australia for Treatment of Acetaminophen Poisoning

Mar 30, 2010
Acetadote® Supplemental New Drug Application for Acute Liver Failure Submitted to FDA

Dec 1, 2009
Newly Published Acetadote® Data Shows Product Can Provide Substantial Cost-Savings for Healthcare Systems

Indication

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.

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.

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.

View full Prescribing Information