AHFS Class:

28:08.16 Non-Opioid Analgesics

Generic Name

• Acetaminophen

Acetaminophen is available as a 10-mg/mL injection solution in glass vials and bags containing 500 mg or 1 g of acetaminophen.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹ Each mL of acetaminophen injection (Ofirmev, Mallinckrodt) solution also contains mannitol 38.5 mg, cysteine hydrochloride monohydrate 0.25 mg, and dibasic sodium phosphate 0.104 mg with hydrochloric acid and/or sodium hydroxide to adjust the pH.²⁸⁴⁰ Each mL of acetaminophen injection (Braun) solution also contains mannitol 38 mg, sodium citrate dihydrate 0.3 mg, and water for injection with glacial acetic acid to adjust the pH.³⁶⁶⁸ Each mL of acetaminophen injection (Fresenius Kabi) solution also contains mannitol 36.7 mg, cysteine 0.1 mg, and water for injection with hydrochloric acid and sodium hydroxide to adjust the pH.³⁶⁶⁹

pH

Acetaminophen injection (Ofirmev, Mallinckrodt) has a pH of approximately 5.5.²⁸⁴⁰

Acetaminophen injection (Braun) has a pH of approximately 5.³⁶⁶⁸

Acetaminophen injection (Fresenius Kabi) has a pH between 5 and 6.3.³⁶⁶⁹

Tonicity

Acetaminophen 10-mg/mL injection is isotonic.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

Osmolality

Acetaminophen 10-mg/mL injection has an osmolality of approximately 290 mOsm/kg.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

Trade Name(s)

Ofirmev

Manufacturers state that care should be taken in the prescribing, preparation, and administration of acetaminophen injection to avoid dosing errors that could result in accidental overdose and death.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹ In particular, manufacturers recommend that dosage in terms of mg or mL not be confused, that dosing in patients weighing less than 50 kg is weight based, that infusion pumps are programmed properly, and that the calculated total daily dosage of acetaminophen (from all routes of administration and from all acetaminophen-containing sources, including combination products) not exceed the maximum recommended dosage.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

For the administration of doses equal to the total amount of acetaminophen in a container, the dose should be administered by inserting a vented intravenous infusion set directly into the septum of the glass vial or by inserting an appropriate intravenous infusion set through the appropriate port of the bag.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

For the administration of doses less than the total amount of acetaminophen in a container, the manufacturers state that the appropriate dose of acetaminophen 10-mg/mL injection should be withdrawn from the intact, sealed container and the measured dose transferred to an empty sterile container (e.g., glass bottle, plastic intravenous container, syringe), employing aseptic technique.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹ The manufacturers state that the entire 100-mL container is not intended for use in patients weighing less than 50 kg.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹ Volumes less than 60 mL (e.g., pediatric doses) should be placed in syringes and administered over 15 minutes using a syringe pump.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

Acetaminophen injection should be administered by intravenous infusion over 15 minutes.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

Acetaminophen injection is a clear, colorless solution.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹ Intact containers should be stored at controlled room temperature and should not be refrigerated nor frozen.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹

Containers are for single use; any unused portions should be discarded.²⁸⁴⁰; ³⁶⁶⁸; ³⁶⁶⁹ Most acetaminophen injection products should be used within 6 hours after opening.²⁸⁴⁰; ³⁶⁶⁹ Acetaminophen injection (Braun) should be used immediately after opening.³⁶⁶⁸

Syringes

To assess stability in syringes, acetaminophen 10-mg/mL injection solution was withdrawn from the original glass vial in volumes of 10, 25, and 50 mL and repackaged undiluted in 10-, 30-, and 60-mL propylene syringes, respectively, to be stored at 23 to 25°C.²⁸⁴⁵ After 84 hours, no physical changes were detected by visual assessment, and the injection solution retained greater than 90% of the mean initial concentration regardless of storage container.²⁸⁴⁵ Sterility, however, was not assessed.²⁸⁴⁵

Solution Compatibility

Additive Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Additional Compatibility Information

Infusion Solutions

Acetaminophen injection solution was found to be compatible with the following additional infusion solutions via simulated Y-site co-administration: dextrose 5% in Ringer’s injection, lactated; dextrose 5% in sodium chloride 0.9%; dextrose 10%; and Ringer’s injection, lactated.²⁸⁴¹; ²⁸⁴⁴

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions October 10, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.