COMBUNOX.pdf

021378s006lbl.pdf
Preview of COMBUNOX
🔗 Source: accessdata.fda.gov
📊 Size: 329 KB
👤 Author: fda/cder
⬇️ Downloads: 62

Summary

CombunoxTM (Oxycodone HCl and Ibuprofen) Tablets are a fixed combination of the opioid analgesic oxycodone and the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen, used for managing moderate to severe pain. The combination is available in tablet form for oral administration. Oxycodone works by binding to opiate receptors in the central nervous system, while ibuprofen inhibits cyclooxygenase activity and prostaglandin synthesis. Combunox is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery and may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, as well as gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines. Clinical studies have shown Combunox to be effective in managing acute, moderate to severe pain, producing greater efficacy than placebo and its individual components. However, it should be used with caution, considering the potential benefits and risks, and at the lowest effective dose for the shortest duration.

Description

CombunoxTM (Oxycodone HCl and Ibuprofen) Tablets are a fixed combination of the opioid analgesic oxycodone and the nonsteroidal anti-inflammatory drug (NSAID)...

Technical Information

  • File Format: PDF
  • File Size: 329 KB
  • Pages: 21
  • Language: EN
  • Author: fda/cder
  • Total Downloads: 62
  • Last Updated: 1 week ago

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This PDF document about COMBUNOX provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into COMBUNOX.

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