Acetaminophen

Patients with Renal Impairment In cases of severe renal impairment (creatinine clearance less than or equal to 30 mL/min), longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.

Patients with Hepatic Impairment Acetaminophen is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease [see Warnings and Precautions and Clinical Pharmacology] . A reduced total daily dose of acetaminophen may be warranted.

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 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.

Instructions for Intravenous Administration from polypropylene bag 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. Identify Twist-off Port (See Figure A ). To Attach Administration Set To aseptically remove the top portion of twist off port: hold container below the twist-off port and twist between the thumb and forefinger as shown in Figure B Steps 1 and 2 .

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. Polypropylene bag container can be safely transported in a standard 6-inch carrier through pneumatic tube system that is well maintained and running properly.

Figure A Figure B Figure C

Instructions for Intravenous Administration of Doses Not Equivalent to 500 mg or 1,000 mg Doses that are not equivalent to 500 mg or 1,000 mg require aseptic transfer to a separate container prior to dispensing. Discard unused portion. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed polypropylene bag 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 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.