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.
Acetylcysteine injection Concentration | Osmolarity | ||
---|---|---|---|
Sterile Water for Injection | ½ Normal Saline | D5W | |
| |||
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:
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 | |
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 |
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 |
---|---|---|---|
| |||
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 |
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 |
---|---|---|---|
| |||
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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