ACETYLCYSTEINE injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

acetylcysteine (UNII: WYQ7N0BPYC) (acetylcysteine - UNII:WYQ7N0BPYC)

Tilgængelig fra:

Sagent Pharmaceuticals

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 miscarriage

Produkt oversigt:

Acetylcysteine Injection is supplied as a 20% solution (200 mg per mL) 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. Storage Conditions Store unopened vials at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ACETYLCYSTEINE- ACETYLCYSTEINE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
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, 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
Acetaminophen Ingestion (2.2):