ACETYLCYSTEINE injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Padagis US LLC

INN (International Adı):

ACETYLCYSTEINE

Kompozisyon:

ACETYLCYSTEINE 200 mg in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 mi

Ürün özeti:

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. Store unopened vials at controlled room temperature, 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

ACETYLCYSTEINE- ACETYLCYSTEINE INJECTION
PADAGIS US 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, 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). (1)
DOSAGE AND ADMINISTRATION
Pre-Treatment Assessment Following Acute Ingestion (2.1): (2)
Obtain a plasma or serum sample to assay for acetaminophen
concentration at least 4 hours after
ingestion. (2)
•
•
•
•
Nomogram for Estimating Potential for Hepatotoxicity from Acute
Acetaminophen Ingestion (2.2): (2)
•
Preparation and Storage of Diluted Solution Prior to Administration
(2.3): (2)
Acetylcysteine injection is hyperosmolar (2600 mOsmol/L), therefore
acetylcysteine injection must be
diluted in sterile water for injection, 0.45% sodium chloride
injection, or 5% dextrose in water injection prior
to intravenous administration. See Full Prescribing Information for
examples of osmolarity depending on
the type of solution and ACETADOTE concentration. (2)
Recommended Adult and Pediatric Dosage (2.4): (2)
•
•
•
•
If the time of acetaminophen ingestion is unknown:
o
o
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:
o
Administer a loading dose of acetylcysteine injection immediately and
continue treatment for a
total of three doses over 21 hours.
If the