Safety and Pharmacokinetic (PK) Study of Intravenous (IV) Acetaminophen Administration in Pediatric Inpatients

Exclusion Criteria

• •1. Is not able to comply with the plasma sampling requirements of the Study
• •2. Has known or suspected hypersensitivity to acetaminophen or the inactive excipients of IV Acetaminophen.
• •3. Has been taking any acetaminophen-containing product in the 12 hours prior or any of the following in the 48 hours prior to randomization in the Study: probenecid, disulfiram, isoniazide, St. John's wort, skullcap, chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, and valerian
• •4. Has any significant medical condition that in the opinion of the Investigator contraindicates participation in the Study
• •5. Has impaired liver function, with evidence of clinically significant liver disease, or other condition that may suggest the potential for an increased susceptibility to hepatic toxicity with IV APAP exposure. For this criterion, a total bilirubin greater than 1.5 times upper limit of normal (ULN) for age or an Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or Aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT) greater than 2.5 times ULN for age will be deemed as evidence of clinically significant (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 2) liver dysfunction or disease.
• •6. Has significantly impaired renal function or known significant renal disease, as evidenced by an estimated glomerular filtration rate (using the Schwartz formula) calculated to be less than 1/3rd of normal for the applicable age strata
• •7. Has participated in another interventional clinical Study (investigational or marketed product) within 30 days of the planned Study randomization date