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Cetylev Approval History

Cetylev (acetylcysteine) is an antidote for acetaminophen overdose indicated to prevent or lessen liver damage after the ingestion of a potentially hepatotoxic quantity of acetaminophen.

Acetaminophen overdose is the most common poisoning reported to emergency rooms in the United States. Acetylcysteine was first approved for use in 1963, and is currently available generically as an intravenous injection and as a solution for inhalation. Oral solutions until now have been prepared by pharmacists who mix the solution for inhalation with diet cola.

Cetylev comes in the form of effervescent tablets intended to be mixed with water to form a lemon-mint solution. The solution is prepared by dissolving the appropriate number of 500 mg or 2.5 gram tablets in a specified volume of water. The recommended dosage for adults and children is an oral loading dose of 140 mg/kg. The maintenance dosage is 70 mg/kg given orally and repeated every 4 hours for a total of 17 doses.

Warnings and precautions of Cetylev include hypersensitivity reactions and risk of upper gastrointestinal hemorrhage. Common side effects include nausea, vomiting, other gastrointestinal symptoms, and rash with or without fever.

Development History and FDA Approval Process for Cetylev

Feb  9, 2016Approval Arbor Pharmaceuticals Announces FDA Approval of Cetylev

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