ACETAMINOPHEN injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

から入手可能:

Hikma Pharmaceuticals USA Inc.

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Acetaminophen injection is indicated for Acetaminophen is contraindicated: Risk Summary Published epidemiological studies with oral acetaminophen use during pregnancy have not reported a clear association with acetaminophen use and birth defects, miscarriage, or adverse maternal or fetal outcomes [see Data] . Animal reproduction studies have not been conducted with IV acetaminophen. Reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen. Treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (MHDD) showed evidence of fetotoxicity and increases in bone variations in the fetuses. In another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the MHDD. In mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity wer

製品概要:

Acetaminophen injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL) in cartons of 24 vials. NDC 24201-100-24 Acetaminophen injection should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. For single-dose only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ACETAMINOPHEN- ACETAMINOPHEN INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACETAMINOPHEN
INJECTION FOR INTRAVENOUS USE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
ACETAMINOPHEN INJECTION FOR INTRAVENOUS USE.
ACETAMINOPHEN INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1951
WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
TAKE CARE WHEN PRESCRIBING, PREPARING, AND ADMINISTERING ACETAMINOPHEN
INJECTION
FOR INTRAVENOUS USE TO AVOID DOSING ERRORS WHICH COULD RESULT IN
ACCIDENTAL OVERDOSE
AND DEATH.
ACETAMINOPHEN INJECTION FOR INTRAVENOUS USE CONTAINS ACETAMINOPHEN.
ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE,
AT TIMES
RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER
INJURY ARE ASSOCIATED
WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED THE RECOMMENDED
MAXIMUM
DAILY LIMITS, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING
PRODUCT. (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.5)
11/2016
Dosage and Administration (2.4)
01/2017
INDICATIONS AND USAGE
ACETAMINOPHEN injection for intravenous use is indicated for the
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DOSAGE AND ADMINISTRATION
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ADULTS AND ADOLESCENTS WEIGHING 50 KG AND OVER:
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ADULTS AND ADOLESCENTS WEIGHING UNDER 50 KG:
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CHILDREN:
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NEONATES AND INFANTS:
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Management of mild to moderate pain in adult and pediatric patients 2
years and older (1)
Management of moderate to severe pain with adjunctive opioid
analgesics in adult and pediatric
patients 2 years and older (1)
Reduction of fever in adult and pediatric patients (1)
ACETAMINOPHEN injection for intravenous use may be given as a single
or repeated dose. (2.1)
ACETAMINOPHEN injection for intravenous use should be administered
only as a 15-minute
intravenous infusion. (2.4)
1000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4000 mg
per day. Minimum