Acetadote FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 17, 2024.
FDA Approved: Yes (First approved January 23, 2004)
Brand name: Acetadote
Generic name: acetylcysteine
Dosage form: Injection
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Acetaminophen Overdose
Acetadote (acetylcysteine) is an antidote used to prevent or lessen potential liver damage resulting from acetaminophen overdose.
- Acetadote is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).
- Accidental or intentional acetaminophen poisoning can lead to serious liver damage.
- Acetadote is thought to work to protect the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite of acetaminophen.
- Acetadote is administered by intravenous infusion as either: 3 separate doses infused over a total of 21 hours OR 2 separate doses infused over a total of 20 hours. The critical ingestion-treatment interval for maximal protection against severe hepatic injury is between 0 and 8 hours. Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post-ingestion of acetaminophen yields limited efficacy. However, it does not appear to worsen the condition of patients and it should not be withheld, since the reported time of ingestion may not be correct.
- Warnings and precautions associated with Acetadote include hypersensitivity reactions and fluid overload.
- Common adverse reactions (> 2%) include rash, urticaria/facial flushing and pruritus.
Development timeline for Acetadote
| Date | Article |
|---|---|
| Dec 9, 2024 | Approval FDA Approves Simplified Dosing Regimen for Acetadote (N-acetylcysteine for injection) |
| Dec 19, 2008 | Approval Cumberland Pharmaceuticals Reports FDA Approval for Updated Labeling of Acetadote |
| Jan 23, 2004 | Approval Acetadote Cumberland Pharmaceuticals - Treatment for Acetaminophen Overdose |
Further information
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