Acetaminophen And Ibuprofen Injection

1 INDICATIONS AND USAGE COMBOGESIC IV is indicated in adults where an intravenous route of administration is considered clinically necessary for: • the relief of mild to moderate pain • the management of moderate to severe pain as an adjunct to opioid analgesics Limitations of Use COMBOGESIC IV is indicated for short-term use of five days or less. COMBOGESIC IV is indicated in adults where an intravenous route of administration is considered clinically necessary for: • the relief of mild to moderate pain • the management of moderate to severe pain as an adjunct to opioid analgesics Limitations of Use COMBOGESIC IV is indicated for short-term use of five days or less.

6 ADVERSE REACTIONS The following clinically significant adverse reactions to ibuprofen or acetaminophen are described elsewhere in other sections of the labelling. • Hepatotoxicity [see Warnings and Precautions (5.2) ] • Cardiovascular Thrombotic Events [see Warnings and Precautions (5.3) ] • Gastrointestinal Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.4) ] • Hypertension [see Warnings and Precautions (5.5) ] • Heart Failure and Edema [see Warnings and Precautions (5.6) ] • Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.7) ] • Hypersensitivity and Anaphylactic Reactions [see Warnings and Precautions (5.8) ] • Exacerbation of Asthma Related to Aspirin Sensitivity [see Warnings and Precautions (5.9) ] • Serious Skin Reactions [see Warnings and Pr...

8.1 Pregnancy Risk Summary Use of NSAID-containing products, including COMBOGESIC IV, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of COMBOGESIC IV use between about 20 and 30 weeks of gestation and avoid COMBOGESIC IV use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data) .

BOXED WARNING WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, and GASTROINTESTINAL RISK RISK OF MEDICATION ERRORS: Take care when prescribing, preparing, and administering COMBOGESIC IV to avoid dosing errors which could result in accidental overdose and death ( 5.1 ). HEPATOTOXICITY: COMBOGESIC IV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. 5 WARNINGS AND PRECAUTIONS • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.5 ) • Heart Failure and Edema: Avoid use of COMBOGESIC IV in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. ( 5.6 ) • Renal Toxicity: Long-term administration of NSAIDs, including the ibuprofen component of COMBOGESIC IV, has resulted in renal papillary necrosis and other renal injury. ( 5.7 ) • Anaphylactic Reactions: Discontinue use immediately if symptoms occur. ( 5.8 ) • Exacerbation of Asthma Related to Aspirin Sensitivity: COMBOGESIC IV is contraindicated in patients with aspirin-sensitive asthma. 4 CONTRAINDICATIONS COMBOGESIC IV is contraindicated in: • patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to acetaminophen, ibuprofen, other NSAIDs or to any other components of this product [see Warnings and Precautions (5.8 , 5.10 , 5.11 )] • patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or ot...