November 16, 2023

FDA Approves New Formulation of Combogesic

The FDA has approved a new IV formulation of Combogesic® (acetaminophen and ibuprofen), with an expanded indication.

Originally approved in tablet formulation in March of 2023, Combogesic was previously approved for the short term management of mild to moderate acute pain. This new IV formulation shares that indication, as well as the management of moderate to severe pain as an adjunct to opioid analgesics.

Combogesic should be limited to five days of use or less. Combogesic features similar warnings that respectively come with acetaminophen and ibuprofen products.

Acetaminophen can be associated with cases of acute liver failure, usually when doses of acetaminophen exceed 4,000 milligrams per day, often involving more than one acetaminophen containing product. Like any NSAID, Combogesic can cause increased risk of serious cardiovascular thrombotic events, and serious gastrointestinal adverse events.

Adverse reactions include infusion site pain, nausea, constipation, dizziness, infusion site extravasation, vomiting, headache, and somnolence.

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