ACETYLCYSTEINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Xellia Pharmaceuticals USA LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine injection is contraindicated in patients with a previous hypersensitivity reaction to acetylcysteine [see Warnings and Precautions (5.1)]. Risk Summary Limited published case reports and case series of pregnant women exposed to acetylcysteine during various trimesters are not sufficient to inform any drug associated risk. Delaying treatment of acetaminophen overdose may increase the risk of maternal or fetal morbidity and mortality [see Clinical Considerations]. Reproduction studies in rats and rabbits following oral administration of acetylcysteine during the period of organogenesis at doses similar to the total intravenous dose (based on the body surface area) did not cause any adverse effects to the fetus. The estimated background risk of major birth defects and misc

Product summary:

Acetylcysteine injection (acetylcysteine) is available as a 20% solution (200 mg/mL) in 30 mL single-dose glass vials. Each single dose vial contains 6 g/30mL (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. Store unopened vials at controlled room temperature, 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                ACETYLCYSTEINE- ACETYLCYSTEINE INJECTION, SOLUTION
XELLIA PHARMACEUTICALS 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 (ACETYLCYSTEINE), FOR INTRAVENOUS USE
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 in patients with an acute
ingestion or from repeated supratherapeutic ingestion (RSI) (1).
DOSAGE AND ADMINISTRATION
Pre-Treatment Assessment Following Acute Ingestion (2.1):
Obtain a plasma or serum sample to assay for acetaminophen
concentration at least 4 hours after
ingestion.
If the time of acetaminophen ingestion is unknown:
Administer a loading dose of Acetylcysteine injection immediately.
Obtain an acetaminophen concentration to determine need for continued
treatment.
If the acetaminophen concentration cannot be obtained (or is
unavailable or uninterpretable) within the
8-hour time interval after acetaminophen ingestion or there is
clinical evidence of acetaminophen
toxicity:
Administer a loading dose of Acetylcysteine injection immediately and
continue treatment for a total
of three doses over 21 hours.
If the patient presents more than 8 hours after ingestion and the time
of acute acetaminophen
ingestion is known:
Administer a loading dose of Acetylcysteine injection immediately.
Obtain acetaminophen concentration to determine need for continued
treatment.
If the patient presents less than 8 hours after ingestion and the time
of acute acetaminophen ingestion
is known and the acetaminophen concentration is known:
Use the Rumack-Matthew nomogram (Figure 1) to determine whether or not
to initiate treatment
with Acetylcysteine injection (2.2).
Nomogram for Estimating Potential for Hepatotoxicity from Acute
Acetam
                                
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