Acetaminophen

ACETAMINOPHEN- acetaminophen injection, solution
Mylan Institutional LLC

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

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