Combogesic IV FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 31, 2023.
FDA Approved: Yes (First approved October 17, 2023)
Brand name: Combogesic IV
Generic name: acetaminophen and ibuprofen
Dosage form: Injection
Company: AFT Pharmaceuticals Ltd.
Treatment for: Postoperative Pain
Combogesic IV (acetaminophen and ibuprofen) is an analgesic and nonsteroidal anti-inflammatory drug (NSAID) combination for the management of postoperative pain.
- 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. - Combogesic IV contains acetaminophen 1000 mg and ibuprofen 300 mg in 100 mL solution for infusion.
- FDA approval for Combogesic IV was based on positive data from a Phase 3 program in which Combogesic IV demonstrated that it was well tolerated and offered faster onset of action than the same dose of either acetaminophen IV or ibuprofen IV alone.The superior analgesic effect of Combogesic IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.
- Combogesic IV is administered as a 15-minute infusion every 6 hours, as necessary.
- The Combogesic IV product label carries a Boxed Warning for hepatotoxicity, increased risk of cardiovascular thrombotic events, and an increased risk of serious gastrointestinal adverse. Warnings and precautions associated with Combogesic IV include impaired response to some antihypertensive medications, risk of worsening heart failure in patients with severe heart failure, renal toxicity, hypersensitivity and anaphylactic reactions, exacerbation of asthma related to aspirin sensitivity, serious skin reactions, drug rash with eosinophilia and systemic symptoms (DRESS), anemia, and fetal toxicity.
- Common adverse reactions include infusion site pain, nausea, constipation, dizziness, infusion site extravasation, vomiting, headache, and somnolence.
- Combogesic IV is marketed outside the United States as Maxigesic IV (paracetamol and ibuprofen). Maxigesic IV is licensed in over 100 countries, approved in over 40 countries and marketed in over 20 countries.
Development timeline for Combogesic IV
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
