Acetadote

Acetadote is an FDA approved injection used to treat acetaminophen overdose.

Acetadote (acetylcysteine) is used in an emergency room setting to prevent or lessen potential liver damage resulting from an overdose of acetaminophen. Often an overdose of acetaminophen is unintentional, as it is a common ingredient in many over-the-counter painkillers. 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 was the first FDA approved injection for the treatment of acetaminophen overdose available in the United States.

Pre-Treatment Assessment Following Acute Ingestion:

Prior to initiating treatment with Acetadote, decide whether the three-bag or two-bag regimen will be used.

Obtain a plasma or serum sample to assay for acetaminophen concentration at least 4 hours after ingestion.

• If the time of acetaminophen ingestion is unknown: Administer a loading dose of ACETADOTE immediately. Obtain an acetaminophen concentration to determine need for continued treatment.
• If the acetaminophen concentration cannot be obtained (or is unavailable or uninterpretable) within the 8-hour time interval after acetaminophen ingestion or there is clinical evidence of acetaminophen toxicity: Administer a loading dose of Acetadote immediately and continue treatment for a total of two doses over 20 hours or three doses over 21 hours.
• If the patient presents more than 8 hours after ingestion and the time of acute acetaminophen ingestion is known: Administer a loading dose of Acetadote immediately Obtain acetaminophen concentration to determine need for continued treatment
• If the patient presents less than 8 hours after ingestion and the time of acute acetaminophen ingestion is known and the acetaminophen concentration is known: Use the revised Rumack-Matthew nomogram (Figure 1) to determine whether or not to initiate treatment with Acetadote.

See Full Prescribing Information for examples of osmolarity depending on the type of solution and Acetadote concentration.

General Considerations for Selecting the Three-Bag or Two-Bag Regimen:

• It is not known whether the two-bag regimen is comparable to the three-bag regimen in preventing hepatotoxicity.
• Patients 40 kg or less should receive the three-bag regimen.
• For patients weighing 41 kg or greater, the three-bag regimen may be preferred for those with early signs of severe liver injury or a large acetaminophen ingestion.

Recommended Dosage for Acute Acetaminophen Ingestion:

• ACETADOTE is for intravenous administration only
• Total dosage of ACETADOTE is 300 mg/kg given intravenously as either: 3 separate doses infused over a total of 21 hours 2 separate doses infused over a total of 20 hours.

See Full Prescribing Information for weight-based dosage and weight-based dilution (2.5)

See Full Prescribing Information for recommendations for continuing ACETADOTE treatment after 21 hours (2.2).

Repeated Supratherapeutic Acetaminophen Ingestion:

• Obtain acetaminophen concentration and other laboratory tests to guide treatment; revised Rumack-Matthew nomogram does not apply.

Nomogram for Estimating Potential for Hepatotoxicity from Acute Acetaminophen Ingestion:

See Full Prescribing Information for instructions on how to use the nomogram to determine the need for dosing.

Preparation and Storage of Diluted Solution Prior to Administration (2.3):

Important Safety Information

Who should not use Acetadote?

Do not use Acetadote if you have had a previous allergic reaction to acetylcysteine.

What are the warnings and precautions?

• Allergic Reactions: Fatal or life-threatening allergic reactions, rash, low blood pressure, wheezing, shortness of breath, and bronchospasm have been observed. Your healthcare provider will monitor you during and after the infusion.
• Fluid Overload: The total volume of fluid given should be reduced for patients weighing less than 40 kg and for those who need fluid restriction. Receiving too much fluid can lead to low blood sodium (hyponatremia), seizures, and death.
• Pregnancy and Breastfeeding: Delaying treatment for an acetaminophen overdose can increase the risk of harm or death to a pregnant woman and her unborn baby. If you are breastfeeding, you may consider pumping and throwing away your breast milk for 30 hours after receiving this medicine.