ACETADOTE- acetylcysteine injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Acetylcysteine (UNII: WYQ7N0BPYC) (Acetylcysteine - UNII:WYQ7N0BPYC)

Mevcut itibaren:

Cumberland Pharmaceuticals Inc.

INN (International Adı):

Acetylcysteine

Kompozisyon:

Acetylcysteine 200 mg in 1 mL

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

ACETADOTE 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). ACETADOTE 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 for the indicated po

Ürün özeti:

ACETADOTE (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/30mL (200 mg/mL) of ACETADOTE injection. ACETADOTE 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 ACETADOTE 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 ACETADOTE 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

Ürün özellikleri

ACETADOTE- ACETYLCYSTEINE INJECTION, SOLUTION
CUMBERLAND PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACETADOTE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACETADOTE.
ACETADOTE (ACETYLCYSTEINE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
ACETADOTE 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 ACETADOTE 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 ACETADOTE 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 ACETADOTE 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 ACETADOTE (2.2)
Nomogram for Estimating Potential for Hepatotoxicity from Acute
Acetaminophen Ingestion (2.2):
See Full Prescribing Information for instructions on how to use the
nomogram to determine th