A summary of all safety data collected related to Maxigesic acetaminophen+ibuprofen tablets.

What is it about?

The combined use of acetaminophen and ibuprofen for pain management has many potential benefits over other pharmaceutical treatments such as opioids (codeine, tramadol, oxycodone, morphine, etc). It has been shown previously that a combination acetaminophen and ibuprofen fixed dose product provides increased pain relief compared to the individual components. There remains uncertainty over the safety of combining these products, in particular the use of ibuprofen following surgery, due to the increased risk of post-operative bleeding which is common in drugs of this type (nonsteroidal anti-inflammatory drugs; NSAIDs). This paper examines the safety profile of a combination acetaminophen and ibuprofen product using pooled clinical trial data. The clinical trials examined multiple doses in tablet form of the combination therapy. Patients were provided with the maximum recommended dose of either acetaminophen alone, ibuprofen alone, the combination, or a placebo tablet during the 24-48 h following either dental or knee surgery. Overall, the combination tablets are well tolerated. The safety profile was found to be the same as acetaminophen or ibuprofen when taken alone. Together with the additional pain relief provided by the combination, this shows an improved and beneficial treatment that can be well tolerated following surgery.

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Why is it important?

Providing effective and safe alternatives and adjuncts to opioids after surgery will lead to improved pain relief and reduce opioid related adverse events. Our findings show that combination acetaminophen+ibuprofen tablets are well tolerated at single doses and multiple doses over a 24-72 hour period. This was further supported by an exploratory trial during which multiple doses were taken daily for 1 year. The efficacy of acetaminophen+ibuprofen combination tablets have been examined previously and found to be as effective as weak opioids in post-surgical settings.