ACETYLCYSTEINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC)

Available from:

Paddock Laboratories, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incidences are divided into two types; Acute Ingestion or Repeated Supratherapeutic Ingestion (RSI). [see Dosage and Administration (2) and Acetaminophen Assays – Interpretation and Methodology-(Acute or Repeated Supratherapeutic Ingestion) (1.1, 1.2) ]. On admission for suspected acute acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately. Acetylcysteine Injection should be administered within 8 hours from acetaminophen ingestion for maximal protection against hepatic injury for patients whose serum acetaminophen levels fall above the “possib

Product summary:

Acetylcysteine Injection is available as a 20% solution (200 mg/mL) in 30 mL single dose glass vials. Each single dose vial contains 6 g/30 mL (200 mg/mL) of Acetylcysteine Injection. Acetylcysteine Injection is sterile and can be used for intravenous administration. It is available as follows: Do not use previously opened vials for intravenous administration. Note: The color of Acetylcysteine Injection 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. The stopper in the Acetylcysteine Injection vial is formulated with a synthetic base-polymer and does not contain Natural Rubber Latex, Dry Natural Rubber, or blends of Natural Rubber. Storage Store unopened vials at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

ACETYLCYSTEINE- ACETYLCYSTEINE INJECTION
PADDOCK LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACETYLCYSTEINE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACETYLCYSTEINE
INJECTION.
ACETYLCYSTEINE INJECTION
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Acetylcysteine Injection is an antidote for acetaminophen overdose
indicated to prevent or lessen hepatic injury after
ingestion of a potentially hepatotoxic quantity of acetaminophen (1)
DOSAGE AND ADMINISTRATION
The total dose of Acetylcysteine Injection is 300 mg/kg given as 3
separate doses and administered over a total of 21 hrs.
Please refer to the guidelines below for dose preparation based upon
patient weight. (2)
DOSING FOR PATIENTS WHO WEIGH 5 KG TO 20 KG (2.1): (2)
Loading Dose: 150 mg/kg diluted in 3 mL/kg of diluent* administered
over 1 hr (2)
Second Dose: 50 mg/kg diluted in 7 mL/kg of diluent* administered over
4 hrs (2)
Third Dose: 100 mg/kg diluted in 14 mL/kg of diluent* administered
over 16 hrs (2)
DOSING FOR PATIENTS WHO WEIGH 21 KG TO 40 KG (2.1): (2)
Loading Dose: 150 mg/kg diluted in 100 mL of diluent* administered
over 1 hr (2)
Second Dose: 50 mg/kg diluted in 250 mL of diluent* administered over
4 hrs (2)
Third Dose: 100 mg/kg diluted in 500 mL of diluent* administered over
16 hrs (2)
DOSING FOR PATIENTS WHO WEIGH 41 KG TO 100 KG (2.1): (2)
Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered
over 1 hr (2)
Second Dose: 50 mg/kg diluted in 500 mL of diluent* administered over
4 hrs (2)
Third Dose: 100 mg/kg diluted in 1000 mL of diluent* administered over
16 hrs (2)
*Acetylcysteine Injection is compatible with the following diluents;
5% Dextrose in Water, 0.45% Sodium Chloride
Injection, and Sterile Water for Injection (2)
DOSING FOR PATIENTS WHO WEIGH MORE THAN 100 KG (2.1): (2)
No specific studies have been conducted to evaluate the use of or
necessity of dosing adjustments in patients weighing
over 100 kg. (2)