Acetaminophen

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older the reduction of fever in adult and pediatric patients 2 years and older. Acetaminophen Injection is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older. Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. Reduction of fever in adult and pediatric patients 2 years and older

The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.

Acetaminophen Injection may be given as a single or repeated dose. Acetaminophen Injection should be administered only as a 15-minute intravenous infusion. Adults and Adolescents Weighing 50 kg and Over: 1,000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4,000 mg per day. Minimum dosing interval of 4 hours. Adults and Adolescents Weighing Under 50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Children: Children 2 to 12 years of age: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day.

Acetaminophen is contraindicated: in patients with known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. in patients with severe hepatic impairment or severe active liver disease. Acetaminophen is contraindicated: In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation. In patients with severe hepatic impairment or severe active liver disease.

WARNING: Risk of Medication Errors and Hepatotoxicity Take care when prescribing, preparing, and administering Acetaminophen Injection to avoid dosing errors which could result in accidental overdose and death. Administration of acetaminophen in doses higher than recommended (by all routes of administration and from all acetaminophen-containing products including combination products) may result in hepatic injury, including the risk of liver failure and death. Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min). Discontinue acetaminophen immediately at the first appearance of skin rash and if symptoms associated with allergy or hypersensitivity occur.

The following serious adverse reactions are discussed elsewhere in the labeling: Hepatic Injury Serious Skin Reactions Allergy and Hypersensitivity The most common adverse reactions in patients treated with acetaminophen were nausea, vomiting, headache, and insomnia in adult patients, nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.

Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. Chronic oral acetaminophen use at a dose of 4,000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.

Acetaminophen Injection should be stored at 20°C to 25°C (68° to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not refrigerate or freeze.