Acetadote Dosage

Generic name: acetylcysteine
Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

The total dose of Acetadote is 300 mg/kg given as 3 separate doses and administered over a total of 21 hours. Please refer to the guidelines below for dose preparation based upon patient weight. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction (see Tables 1 and 2).

Administration Instructions (Three–Bag Method: Loading, Second and Third Dose)

Dosing for Patients who weigh 5 kg to 20 kg (Table 1):

Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered over 16 hrs

Table 1. Three Bag Method Dosage Guide by Weight in Patients 5 kg to 20 kg

*Acetadote is compatible with the following diluents; 5% Dextrose in Water, 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

Body
Weight (kg)
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 7mL/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
Acetadote Total Dose Diluent
volume
Acetadote Total Dose Diluent
volume
Acetadote Total 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 140mL
15 kg 2,250 mg 45 mL 750 mg 105mL 1,500 mg 210mL
20 kg 3,000 mg 60 mL 1,000mg 140mL 2,000 mg 280mL

See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

Dosing for patients who weigh 21 kg to 40 kg (Table 2):

Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 500 mL of diluent* administered over 16 hrs

Table 2. Three Bag Method Dosage Guide by Weight in Patients 21 kg to 40 kg

*Acetadote is compatible with the following diluents; 5% Dextrose in Water 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

Body
Weight (kg)
Bag 1 (loading dose):

150 mg/kg in 100 mL of diluent* infused over 1 hr
Bag 2 (second dose)

50 mg/kg in 250 mL of diluent* infused over 4 hrs
Bag 3 (third dose)

100 mg/kg in 500 mL of diluent* infused over 16 hrs
Acetadote
Total Dose (mg)
Acetadote
Total Dose (mg)
Acetadote
Total Dose (mg)
 
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

See also Section 2.2 Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction.

Dosing for patients who weigh 41 kg to 100 kg (Table 3):

Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered over 1 hr

Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over 4 hrs

Third Dose: 100 mg/kg diluted in 1000 mL of diluent* administered over 16 hrs

Table 3. Three Bag Method Dosage Guide by Weight in Patients 41 kg to 100 kg

*Acetadote is compatible with the following diluents; 5% Dextrose 0.45% Sodium Chloride Injection, and Sterile Water for Injection.

Body
Weight (kg)
Bag 1 (loading dose):

150 mg/kg diluted in 200 mL of diluent* infused over 1 hr
Bag 2 (second dose):

50 mg/kg diluted in 500 mL of diluent* infused over 4 hrs
Bag 3 (third dose):

100 mg/kg diluted in 1000 mL of diluent* infused over 16 hrs
Acetadote Total Dose (mg) Acetadote Total Dose (mg) Acetadote Total Dose (mg)  
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

Patients Weighing More Than 100 kg

No specific studies have been conducted to evaluate the use of or necessity of dosing adjustments in patients weighing over 100 kg. Limited information is available regarding the dosing requirements of patients that weigh more than 100 kg. The dose of Acetadote recommended in these patients should be a loading dose of 15,000 mg infused over a period of one hour followed by a first maintenance dose of 5,000 mg over 4 hours and a second maintenance dose of 10,000 mg over 16 hours (See Table 3).

Continued Therapy beyond 21 Hours

While there is no clinical trial data to support infusions beyond 21 hours there is literature that supports continued infusion of acetylcysteine in some rare instances. In cases of suspected massive overdose, or with concomitant ingestion of other substances, or in patients with preexisting liver disease, the absorption and/or the half-life of acetaminophen may be prolonged, in such cases consideration should be given to the need for continued infusion of N-acetylcysteine beyond 21 hours. Acetaminophen levels and ALT/AST & INR should be checked before the end of the 21-hour infusion. If acetaminophen levels are still detectable, or in cases in which the ALT/AST are still increasing or the INR remains elevated, the infusion should be continued, and the treating physician should contact a US regional poison center at 1-800-222-1222, or alternatively, a “special health professional assistance line for acetaminophen overdose” at 1-800-525-6115 for assistance with dosing recommendations.

Volume Adjustment: Patients less than 40 kg and Requiring Fluid Restriction

The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as clinically needed. If the volume of the infusion is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure and death. [see Dosage and Administration (2)].

As Acetadote is hyperosmolar (2600 mOsmol/L), caution is advised when the diluent volume is decreased as the hyperosmolarity of the solution is increased. See Table 4 below for examples.

Table 4. Acetadote Concentration and Osmolarity

*Osmolarity should be adjusted to a physiologically safe level, (generally not less than 150mOsmol/L in children).

Acetadote Concentration (mg/mL) Osmolarity in ½ Normal Saline Osmolarity in D5W Osmolarity in Sterile Water for Injection
7 mg/mL 245 mOsmol/L 343 mOsmol/L 91 mOsmol/L*
24 mg/m/L 466 mOsmol/L 564 mOsmol/L 312 mOsmol/L

Single dose vial, preservative-free, discard unused portion. If vial was previously opened, do not use for intravenous administration.

Stability studies indicate that the diluted solution is stable for 24 hours at controlled room temperature.

Note: The color of Acetadote may turn from essentially colorless to a slight pink or purple once the stopper is punctured. The color change does not affect the quality of the product.

Renal Impairment

No data are available to determine if a dose adjustment in patients with moderate or severe renal impairment is required.

Hepatic Impairment

Although there was a threefold increase in acetylcysteine plasma concentrations in patients with hepatic cirrhosis, no data are available to determine if a dose adjustment in these patients is required. The published medical literature does not indicate that the dose of acetylcysteine in patients with hepatic impairment should be reduced.

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