Acetaminophen

ACETAMINOPHEN- acetaminophen injection
B. Braun Medical Inc.

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 Important Dosing and Administration Information

• DO NOT ADD SUPPLEMENTARY MEDICATION.
• Aseptic technique is required.
• Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.
• Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.
• Use only if solution is clear and container and seals are intact. Single-dose plastic container. Discard unused portion. Consult Package Insert for complete product information.
• DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION.

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 1-3 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 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4,000 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) weighinggreater than or equal to 50 kg	650 mg	1,000 mg	1,000 mg	4,000 mg in 24 hours
Adults and adolescents (13 years and older) weighing less than 50 kg	12.5 mg/kg	15 mg/kg	15 mg/kg (up to 750 mg)	75 mg/kg in 24 hours (up to 3,750 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 3,750 mg)

2.4 Recommended Dosage for Treatment of Fever in Neonates and Infants

Neonates, including premature neonates born at greater than or equal to 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 from PAB® Container

DO NOT ADD SUPPLEMENTARY MEDICATION.

Aseptic technique is required.

Before use, perform the following checks: Read the label. Ensure solution is the one ordered and is within the expiration date.

Inspect the solution in good light for cloudiness, haze or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seals are intact. Single dose plastic container. Discard unused portion. Consult Package Insert for complete product information.

DO NOT USE PLASTIC CONTAINER IN SERIES CONNECTION.

This solution is intended for intravenous administration over 15 minutes using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours.

1. Identify Two Ports (See Figure A).

2. To Attach Administration Set

To aseptically remove the set port closure: hold container below the set port and grasp the foil tab between the thumb and forefinger then pull the tab in two steps as shown in Figure B Steps 1 and 2.

3. Push spike through the diaphragm of the port (See Figure C). Hang container using hole on the lower flap. Prime set in accordance with the Directions for Use provided with the set in use.

PAB® containers can be safely transported in a standard 6-inch carrier through a pneumatic tube system that is well maintained and running properly.