ACETYLCYSTEINE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Fresenius Kabi USA, LLC

INN (mednarodno ime):

ACETYLCYSTEINE

Sestava:

ACETYLCYSTEINE 200 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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 acetaminop

Povzetek izdelek:

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. Acetylcysteine Injection is sterile and can be used for intravenous administration. Acetylcysteine Injection is available as: Unit of Sale Strength Each NDC 63323-963-30 Unit of 4 20% (6 grams per 30 mL) (200 mg per mL) NDC 63323-963-21 30 mL Single Dose glass vial 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].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ACETYLCYSTEINE- ACETYLCYSTEINE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
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.
DOSING FOR PATIENTS WHO WEIGH 5 KG TO 20 KG ( 2.1):
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
DOSING FOR PATIENTS WHO WEIGH 21 KG TO 40 KG ( 2.1):
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
DOSING FOR PATIENTS WHO WEIGH 41 KG TO 100 KG ( 2.1):
Loading Dose: 150 mg/kg diluted in 200 mL of diluent* administered
over 1 hr
Second Dose: 50 mg/kg diluted in 500mL of diluent* administered over 4
hrs
Third Dose: 100 mg/kg diluted in 1,000 mL of diluent* administered
over 16 hrs
* Acetylcysteine Injection is compatible with the following diluents;
5% Dextrose in Water, 0.45% Sodium
Chloride Injection, and Sterile Water for Injection
DOSING FOR PATIENTS WHO WEIGH MORE THAN 100 KG ( 2.1):
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 dos