Acetylcysteine (Page 2 of 5)

2.3 Preparation and Storage of Acetylcysteine injection Diluted Solution Prior to Administration

Because Acetylcysteine injection is hyperosmolar (2600 mOsmol/L), Acetylcysteine injection must be diluted in 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 (5.2)]. Dilution in these three solutions results in different osmolarity of the solution for intravenous administration (see Table 1 for examples of different osmolarity of the solution depending on the type of solution and the Acetylcysteine injection concentration).

Visually inspect for particular 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.

Table 1. Examples of Acetylcysteine injection Concentration and Osmolarity in Three Solutions
Acetylcysteine injection Concentration Osmolarity
Sterile Water for Injection ½ Normal Saline D5W
*
Adjust osmolarity to a physiologically safe level (generally not less than 150 mOsmol/L in pediatric patients).
7 mg/mL 91 mOsmol/L * 245 mOsmol/L 343 mOsmol/L
24 mg/mL 312 mOsmol/L 466 mOsmol/L 564 mOsmol/L

2.4 Recommended Dosage in Adults and Pediatrics for Acute Acetaminophen Ingestion

Acetylcysteine injection is for intravenous administration only.

Dosage Regimen

The total recommended dosage of Acetylcysteine injection 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:

Table 2. Recommended Acetylcysteine injection Dosage and Dilution for Patients 5 kg to 20 kg
Body Weight Bag 1 (Loading Dose)150 mg/kg in 3 mL/kg of diluent * infused over 1 hour Bag 2 (Second Dose)50 mg/kg in 7 mL/kg of diluent * infused over 4 hours Bag 3 (Third Dose)100 mg/kg diluted in 14 mL/kg of diluent * infused over 16 hours
Loading Dose Diluent Volume Second Dose Diluent Volume Third Dose Diluent Volume
*
Dilute Acetylcysteine injection 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.
5 kg 750 mg 15 mL 250 mg 35 mL 500 mg 70 mL
10 kg 1,500 mg 30 mL 500 mg 70 mL 1,000 mg 140 mL
15 kg 2,250 mg 45 mL 750 mg 105 mL 1,500 mg 210 mL
20 kg 3,000 mg 60 mL 1,000 mg 140 mL 2,000 mg 280 mL
Table 3. Recommended Acetylcysteine injection Dosage and Dilution for Patients 21 kg to 40 kg
Body Weight Bag 1 (Loading Dose)150 mg/kg in 100 mL of diluent * infused over 1 hour Bag 2 (Second Dose)50 mg/kg in 250 mL of diluent * infused over 4 hours Bag 3 (Third Dose)100 mg/kg in 500 mL of diluent * infused over 16 hours
*
Dilute Acetylcysteine injection in one of the following three solutions: sterile water for injection, 0.45% sodium chloride injection, or 5% dextrose in water.
21 kg 3,150 mg 1,050 mg 2,100 mg
30 kg 4,500 mg 1,500 mg 3,000 mg
40 kg 6,000 mg 2,000 mg 4,000 mg
Table 4. Recommended Acetylcysteine injection Dosage and Dilution for Patients 41 kg or Greater
Body Weight Bag 1 (Loading Dose)150 mg/kg in 200 mL of diluent * infused over 1 hour Bag 2 (Second Dose)50 mg/kg in 500 mL of diluent * infused over 4 hours Bag 3 (Third Dose)100 mg/kg in 1000 mL of diluent * infused over 16 hours
*
Dilute Acetylcysteine injection 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.
41 kg 6,150 mg 2,050 mg 4,100 mg
50 kg 7,500 mg 2,500 mg 5,000 mg
60 kg 9,000 mg 3,000 mg 6,000 mg
70 kg 10,500 mg 3,500 mg 7,000 mg
80 kg 12,000 mg 4,000 mg 8,000 mg
90 kg 13,500 mg 4,500 mg 9,000 mg
≥ 100 kg 15,000 mg 5,000 mg 10,000 mg

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