Prescription Drug Information: Acetaminophen

ACETAMINOPHEN — acetaminophen injection, solution
Camber Pharmaceuticals, Inc.

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. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.
    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 maximum daily limits, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.1)] .

1 INDICATIONS AND USAGE

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 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Acetaminophen injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and acetaminophen injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen. Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1 to 3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose.

2.2 Recommended Dosage: Adults and Adolescents

Adults and adolescents weighing 50 kg and over: the recommended dosage of acetaminophen injection is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of acetaminophen injection of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4000 mg per day (includes all routes of administration and all acetaminophen-containing products including combination products).
Adults and adolescents weighing under 50 kg: the recommended dosage of acetaminophen injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of acetaminophen injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day (includes all routes of administration and all acetaminophen-containing products including combination products). Table 1. Dosing for Adults and Adolescents

Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes)
Adults and adolescents (13 years and older) weighing ≥ 50 kg 650 mg 1000 mg 1000 mg 4000 mg in 24 hours
Adults and adolescents (13 years and older) weighing < 50 kg 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3750 mg)

2.3 Recommended Dosage: Children


Children 2 to 12 years of age: the recommended dosage of acetaminophen injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of acetaminophen injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day. Table 2. Dosing for Children

Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes)
Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3750 mg)

2.4 Recommended Dosage For Treatment of Fever in Neonates and Infants


Neonates, including premature neonates born at ≥ 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of acetaminophen injection is 12.5 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 50 mg/kg per day, with a minimum dosing interval of 6 hours.
Infants 29 days to 2 years of age: the recommended dosage of acetaminophen injection is 15 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 60 mg/kg per day, with a minimum dosing interval of 6 hours.
Table 3. Dosing for Treatment of Fever in Neonates and Infants

Age group Dose given every 6 hours Maximum total daily dose of acetaminophen (by all routes)
Neonates (birth to 28 days) 12.5 mg/kg 50 mg/kg
Infants (29 days to 2 years) 15 mg/kg 60 mg/kg

2.5 Instructions for Intravenous Administration


For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of acetaminophen injection, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen injection may be administered without further dilution. Examine the container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the container intravenously over 15 minutes. Use aseptic technique when preparing acetaminophen injection for intravenous infusion. Do not add other medications to the acetaminophen injection vial or infusion device.
For doses less than 1000 mg, the appropriate dose must be withdrawn from the container and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed acetaminophen injection container and place the measured dose in a separate empty, sterile container (e.g., glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL container of acetaminophen injection is not intended for use in patients weighing less than 50 kg. Acetaminophen injection is supplied in a single-dose container and the unused portion must be discarded.
Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.
Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the acetaminophen infusion is the primary infusion.
Once the container seal has been penetrated, or the contents transferred to another container, administer the dose of acetaminophen injection within 6 hours. Do not add other medications to the acetaminophen injection solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with acetaminophen injection, therefore do not administer simultaneously.

3 DOSAGE FORMS AND STRENGTHS

Acetaminophen Injection is a sterile, clear, colorless, non-pyrogenic, preservative free, isotonic formulation of acetaminophen intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg acetaminophen (10 mg/mL).

4 CONTRAINDICATIONS

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 [see Warnings and Precautions (5.1)] .

5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Injury

Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death [see Overdosage (10)] . Do not exceed the maximum recommended daily dose of acetaminophen [see Dosage and Administration (2)] . The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products.

Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min) [see Use in Specific Populations ( 8.6, 8.7)] .

5.2 Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

5.3 Risk of Medication Errors

Take care when prescribing, preparing, and administering acetaminophen in order to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits [see Dosage and Administration (2)] .
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