Finished product reference

Acetylcysteine

Granule · Oral · 200 mg

List code
52798
Pharmacologic class
Antidote · Antidote for Acetaminophen Overdose · Mucolytic

What it is and how it works

Mechanism class: Reduction Activity

Indications

Acetylcysteine injection 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). Acetylcysteine injection is an antidote for acetaminophen overdose 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 an acute ingestion or from repeated supratherapeutic ingestion (RSI) .

Dosage and administration (summary)

Pre-Treatment Assessment Following Acute Ingestion : Prior to initiating treatment with Acetylcysteine injection, 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: o Administer a loading dose of Acetylcysteine injection immediately. o Obtain an acetaminophen concentration to determine need for continued treatment.

Contraindications

Acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine . Patients with a previous hypersensitivity reaction to acetylcysteine

Warnings and precautions

Hypersensitivity Reactions: Fatal or life-threatening anaphylaxis, rash, hypotension, wheezing, shortness of breath and/or bronchospasm have been observed. Observe patients during and after the infusion; immediately discontinue infusion if a serious reaction occurs and initiate appropriate treatment. Acetylcysteine injection infusion may be carefully restarted after treatment of hypersensitivity has been initiated and acute symptoms have resolved . Fluid Overload: Total volume administered should be reduced for patients weighing less than 40 kg and for those requiring fluid restriction .

Storage and supply

Acetylcysteine injection (acetylcysteine) injection is available as a 20% solution (200 mg/mL) in 30 mL single-dose glass vials. Each single dose vial contains 6 g/30mL (200 mg/mL) of Acetylcysteine injection. Acetylcysteine injection is sterile and can be used for intravenous administration.

Source: Acetylcysteine (Acetylcysteine) — US FDA prescribing information, 2025-09-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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