Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients

Exclusion Criteria

• •1. Be less than 18 years of age
• •2. Have received antipyretic drug therapy (e.g., aspirin, other NSAIDs, or acetaminophen) within 4 hours before dosing
• •3. Have any history of allergy or hypersensitivity to any component of IVIb, NSAIDs (including aspirin), or COX-2 inhibitors
• •4. Be pregnant or nursing
• •5. Have a history of severe head trauma that required current hospitalization, intracranial surgery, or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesions
• •6. Weigh less than 40 kg
• •7. Have a history of congenital bleeding diatheses (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction, including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
• •8. Have gastrointestinal bleeding that has required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
• •9. Have a platelet count less than 30,000/mm3
• •10. Be receiving full dose anticoagulation therapy
• •11. Have fever secondary to blood or drug reaction
• •12. Have an expected life span of less than 14 days because of imminent withdrawal of life support or severity of illness
• •14. Have neurogenic fever
• •15. Be on dialysis, have oliguria or creatinine greater than 3.0 mg/dL, or be receiving nephrotoxic drugs
• •16. Have had major surgery within the past 12 hours, unless adequate hemostasis has been achieved
• •17. Have received another investigational drug within the past 30 days
• •18. Become afebrile (temperature below 101.0ºF \[38.3ºC\]) before dosing and not redevelop fever entry criteria during this hospitalization
• •19. Be otherwise unsuitable for the study, in the opinion of the Investigator