Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Hikma Pharmaceuticals USA Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
ACETAMINOPHEN- ACETAMINOPHEN INJECTION, SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- 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 • • • DOSAGE AND ADMINISTRATION • • ADULTS AND ADOLESCENTS WEIGHING 50 KG AND OVER: • ADULTS AND ADOLESCENTS WEIGHING UNDER 50 KG: • CHILDREN: • NEONATES AND INFANTS: • 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 Prečítajte si celý dokument