Oxycodone and Ibuprofen Tablets (CombunoxTM)
By William T. Elliott, MD, FACP, and James Chan, PhD, PharmD
A fixed combination of the narcotic analgesic oxycodone and the nonsteroidal anti-inflammatory agent ibuprofen has been approved for the short-term treatment of acute moderate-to-severe pain. This first time combination of these 2 agents is marketed by Forest Laboratories as CombunoxTM.
Oxycodone/ibuprofen is indicated for the short-term (no more than 7 days) management of acute, moderate-to-severe pain.1
The recommended dose is one tablet, not exceeding 4 tablets in 24 hours.
Oxycodone/ibuprofen is supplied as tablets containing 5 mg of oxycodone and 400 mg of ibuprofen.
The combination potentially provides additive analgesic effect of 2 different analgesics without substantially increasing adverse events.
The addition of 5 mg of oxycodone to ibuprofen 400 mg produced similar analgesia to ibuprofen 400 mg in an oral surgery pain model.2 Oxycodone/ibuprofen is approved for acute use only, no more than 7 days. No multiple dose studies have been conducted with this combination.1 It is a schedule CII controlled substance requiring the Schedule II security prescription form.
Oxycodone/ibuprofen was studied in 3 single-dose clinical trials, 2 in patients following dental surgery (n = 949) and the third following abdominal/pelvic surgery (n = 456). Patients were randomized to placebo, oxycodone, ibuprofen, or the combination. Magnitude of pain relief and reduction in pain intensity were assessed over 6 hours. Oxycodone/ibuprofen was reported to be more efficacious than placebo and each individual component.1 However, in a published study using an oral surgery pain model (removal of 2 or 4 molars) (n = 118) the addition of oxycodone 5 mg to ibuprofen showed no statistical difference in analgesia as assessed by the time course of pain intensity using a visual analog scale or pain relief.2 The addition of 10 mg of oxycodone produced significant analgesia over ibuprofen or ibuprofen plus 5 mg oxycodone but also produced greater frequency of adverse effects. The analgesic advantage was detected only over the first 2 hours. The wholesale cost of oxycodone/ibuprofen is $1.20 per tablet.
It is not clear if this new fixed combination offers any clinical advantages over available analgesic combinations as comparative multiple dosing comparisons are not available.
Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; Asst. Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Both are Associate Editors of Internal Medicine Alert.
1. Combunox Product Information. Forest Laboratories. November 2004.
2. Dionne RA. J Oral Maxillofac Surg. 1999;57(6):673-678.