Acetylcysteine

Preview FDA label, Glenmark Pharmaceuticals Inc., USA, intravenous, effective 2026-05-06. Full label on DailyMed

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Dosing in kidney impairment

The reported history of the quantity of acetaminophen ingested as an overdose is often inaccurate and is not a reliable guide to therapy. 2. Obtain the following laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, international normalized ratio (INR), creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes. 3.

Monitor hepatic and renal function and electrolytes throughout treatment. The acetaminophen concentration could not be obtained: Monitor hepatic and renal function and electrolytes throughout treatment. For patients whose acetaminophen concentration is below the treatment line (see Figure 1) and time of ingestion is known and the sample was obtained more than 4 hours after ingestion: Laboratory tests to monitor hepatic and renal function and electrolyte and fluid balance: AST, ALT, bilirubin, INR, creatinine, BUN, blood glucose, and electrolytes.

For specific acetylcysteine dosage and administration information in patients with RSI, consider contacting your regional poison center at 1-800-222-1222, or alternatively, a special health professional assistance line for acetaminophen overdose at 1-800-525-6115.

Preparation and administration

Preparation and Storage of Acetylcysteine Diluted Solution Prior to Administration Because acetylcysteine is hyperosmolar (2600 mOsmol/L), acetylcysteine must be diluted in the recommended volume of sterile water for injection, 0.45% sodium chloride injection (1/2 normal saline), or 5% dextrose in water prior to intravenous administration [see Warnings and Precautions] .

The choice of diluent should be based on the individual patient’s clinical status, concurrent medical conditions, and institutional protocols. The treating clinician should assess each case individually and consult with their pharmacy if there are any concerns about the appropriate diluent choice. In general, 0.45% normal saline is the preferred diluent because it provides a more consistent osmolarity profile, reduces the amount of free water delivered to the patient, and better approximates physiologic fluids than 5% dextrose in water or sterile water for injection.

However, consider 5% dextrose in water or sterile water for injection if sodium load is a concern for the patient. Dilution of acetylcysteine in each of these three solutions results in different osmolarity of the solution for intravenous administration (see Table 1 for examples of different osmolarity of the acetylcysteine solution depending on the type of solution and the acetylcysteine concentration).

Table 1. Examples of [See table below.] *Adjust osmolarity to a physiologically safe level (generally not less than 150 mOsmol/L in pediatric patients). The choice of diluent should be based on the individual patient’s clinical status, concurrent medical conditions, and institutional protocols. The treating clinician should assess each case individually and consult with their pharmacy if there are any concerns about the appropriate diluent choice.

In general, 0.45% normal saline is the preferred diluent, as it provides a more consistent osmolarity profile, reduces the amount of free water delivered to the patient, and better approximates physiologic fluids than 5% dextrose in water or sterile water for injection. Visually inspect for particulate matter and discoloration prior to administration.

The color of the diluted solution ranges from colorless to a slight pink or purple once the stopper is punctured (the color change does not affect the quality of the product). The diluted solution can be stored for 24 hours at room temperature. Discard unused portion. If a vial was previously opened, do not use for intravenous administration.

Recommended Dosage for Acute Acetaminophen Ingestion Acetylcysteine is for intravenous administration only. Dosage Regimen The total recommended dosage of acetylcysteine is 300 mg/kg given intravenously as 3 separate, sequential doses (i.e., 3-bag method to administer the loading, second, and third doses). The total recommended infusion time for 3 doses is 21 hours.

For the recommended weight-based dosage and weight-based dilution in patients who weigh:

5 to 20 kg (see Table 2)

21 to 40 kg (see Table 3)

41 kg or greater (see Table 4) Table 2. Recommended Acetylcysteine Dosage and Dilution for Patients 5 kg to 20 kg [See table below.] *Dilute acetylcysteine in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water. ** Recommended dosing for those less than 5 kg has not been studied.

Table 3. Recommended Acetylcysteine Dosage and Dilution for Patients 21 kg to 40 kg [See table below.] *Dilute acetylcysteine in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water. Table 4. Recommended Acetylcysteine Dosage and Dilution for Patients 41 kg or Greater [See table below.] *Dilute acetylcysteine in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water. ** No specific studies have been conducted to evaluate the necessity of dose adjustments in patients weighing over 100 kg.

Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg.

Osmolarity91 mOsmol/L*245 mOsmol/L343 mOsmol/L312 mOsmol/L466 mOsmol/L564 mOsmol/L
Acetylcysteine Concentration
Sterile Water for Injection½ Normal SalineD5W
7 mg/mL
24 mg/mL
Diluent VolumeDiluent VolumeDiluent Volume
Body WeightBag 1 (Loading Dose)150 mg/kg in 3 mL/kg of diluent* infused over 1 hourBag 2 (Second Dose)50 mg/kg in 7 mL/kg of diluent* infused over 4 hoursBag 3 (Third Dose) 100 mg/kg diluted in 14 mL/kg of diluent* infused over 16 hours
Loading Dose
Second Dose
Third Dose
5 kg**750 mg15 mL250 mg35 mL500 mg70 mL
10 kg1500 mg30 mL500 mg70 mL1000 mg140 mL
15 kg2250 mg45 mL750 mg105 mL1500 mg210 mL
20 kg3000 mg60 mL1000 mg140 mL2000 mg280 mL
150 mg/kg in 100 mL of diluent* infused over 1 hourBag 2 (Second Dose)50 mg/kg in 250 mL of diluent* infused over 4 hours
BodyWeightBag 1 (Loading Dose)
Bag 3 (Third Dose)100 mg/kg in 500 mL of diluent* infused over 16 hours
21 kg3150 mg1050 mg2100 mg
30 kg4500 mg1500 mg3000 mg
40 kg6000 mg2000 mg4000 mg