ACETAMINOPHEN injection, solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Sandoz Inc

Uygulama yolu:

INTRAVENOUS

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Acetaminophen injection is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL). 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. PREMIER ProRx® PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured by S.M. Farmaceutici SRL Potenza, Italy for Sandoz Inc., Princeton, NJ 08540 Rev. March 2021

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

ACETAMINOPHEN- ACETAMINOPHEN INJECTION, SOLUTION
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACETAMINOPHEN
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ACETAMINOPHEN
INJECTION.
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 TO
AVOID DOSING ERRORS WHICH COULD RESULT IN ACCIDENTAL OVERDOSE AND
DEATH.
ACETAMINOPHEN INJECTION 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)
INDICATIONS AND USAGE
Acetaminophen injection 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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DOSAGE FORMS AND STRENGTHS
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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 may be given as a single or repeated dose.
(2.1)
Acetaminophen injection 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 dosing
interval of 4 hours. (2.2)
15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75
mg/kg per day. Minimum
dosing interval of 4 hours. (2.2)
Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg
every 4 hours t