Acetylcysteine is available as a 20% (200 mg/mL) concentrate for injection in 30-mL single-dose preservative-free vials containing 6 g of the drug.2861 Each mL of the concentrate contains acetylcysteine 200 mg in water for injection with sodium hydroxide to adjust the pH.2861 This concentrate must be diluted prior to administration.2861
pH
6 to 7.5.2861
Osmolarity
Acetylcysteine concentrate for injection has an osmolarity of 2600 mOsm/L.2861 The manufacturer provides the osmolarity of acetylcysteine solutions for the following dilutions:2861
Osmolarity (mOsm/L) | |||
---|---|---|---|
Acetylcysteine Concentration | Sterile Water for Injection | Sodium chloride 0.45% | Dextrose 5% |
7 mg/mL | 91 | 245 | 343 |
24 mg/mL | 312 | 466 | 564 |
The osmolarity of acetylcysteine solutions was calculated for the following dilutions:3886
Osmolarity (mOsm/L) | |||
---|---|---|---|
Acetylcysteine Concentration | Dextrose 5% | Sodium chloride 0.45% | Sodium chloride 0.9% |
30 mg/mL | 603 | 521 | 654 |
40 mg/mL | 720 | 643 | 768 |
50 mg/mL | 838 | 766 | 883 |
60 mg/mL | 955 | 889 | 997 |
Trade Name(s)
Acetadote
Acetylcysteine is administered by intravenous infusion after dilution in dextrose 5%, sodium chloride 0.45%, or sterile water for injection.2861 The total recommended dose of the drug is generally administered as 3 sequential intravenous infusions (loading dose, second dose, third dose) over 21 hours.2861 The total volume of the infusions should be adjusted for patients weighing 40 kg or less and those requiring fluid restriction.2861
For patients weighing 41 kg or more, the manufacturer recommends the loading dose be added to 200 mL for infusion over 60 minutes.2861 The second dose should be mixed in 500 mL and delivered over 4 hours.2861 The third dose should be mixed in 1 L and delivered over 16 hours.2861
For patients weighing 21 to 40 kg, the manufacturer recommends the loading dose be added to 100 mL for infusion over 60 minutes.2861 The second dose should be mixed in 250 mL and delivered over 4 hours.2861 The third dose should be mixed in 500 mL and delivered over 16 hours.2861
For patients weighing 5 to 20 kg, the manufacturer recommends the loading dose be diluted in 3 mL/kg of body weight for infusion over 60 minutes.2861 The second dose should be mixed in 7 mL/kg of body weight and delivered over 4 hours.2861 The third dose should be mixed in 14 mL/kg of body weight and delivered over 16 hours.2861
Intact vials of acetylcysteine should be stored at controlled room temperature.2861 The vials are for single use; any unused portion remaining in vials should be discarded.2861 The manufacturer states that the color of acetylcysteine injection may vary from colorless to slight pink or purple after stopper penetration, but this color change does not indicate an adverse effect on drug quality.2861
The manufacturer states diluted solutions may be stored for 24 hours at room temperature.2861
For a list of references cited in the text of this monograph, search the monograph titled References.