I want to recommend asking you doctor about Combunox to anyone who has problems with prescription drugs with tylenol fillers. I recently had my wisdom teeth pulled and I let the doctor know that hydrocodone (w/tylenol filler) makes me sick. He prescribed me Combunox instead and it has ibuprofen as a filler. I get no headaches, don't wake up feeling hung over, and have more energy than ever. Anyways, here is some info.

Combunox� was approved by the FDA on November 19, 2004 for the short-term management of moderate to severe acute pain. Combunox� is a schedule II controlled substance analgesic combination. Each tablet contains oxycodone 5 mg and ibuprofen 400 mg. Oxycodone is an opioid analgesic, which acts on opiate receptors in the central nervous system. Ibuprofen is a nonsteroidal anti-inflammatory agent also used for its analgesic and antipyretic actions. Its actions are attributed to inhibition of cyclooxygenase enzymes as well as inhibition of prostaglandin synthesis.

The oxycodone component is absorbed from the intestinal tract into the blood stream, with maximal concentrations occurring between 1.3 to 2 hours after administration. A 25% increase in oxycodone bioavailability is seen when Combunox� is taken with food. Approximately 45% of the oxycodone is bound to plasma proteins. Metabolism occurs in the liver through N-demethylation, glucuronidation and 6-ketoreduction. O-demethylation also takes place hepatically via the cytochrome P450 2D6 (CYP2D6) enzyme. The elimination half-life is between 3.1 to 3.7 hours.

The ibuprofen component is absorbed into the blood stream with maximal concentrations occurring between 1.6 to 3.1 hours after administration. Absorption is unaffected by the presence of food. Approximately 99% of ibuprofen is bound to plasma proteins. It is hepatically metabolized into two inactive metabolites. The elimination half-life is between 1.8 to 2.6 hours.

Adverse effects frequently experienced with repeated doses of Combunox� include headache (10.2%), nausea (25.4%), somnolence (17.4%), and dizziness (19.2%). Other less frequent adverse effects include asthenia, fever, vasodilation, constipation, diarrhea, dyspepsia and vomiting.

Combunox� has various interactions with other medications based on pharmacokinetic and pharmacodynamic parameters. Metabolism of oxycodone may be affected by medications that induce or downregulate the CYP2D6 enzyme. Other interactions are included in table 1.

The manufacturer�s recommended dose is one tablet for acute pain. The recommended maximum dose is four tablets in a 24 hour period. Combunox� is available as a tablet containing oxycodone 5 mg and ibuprofen 400 mg. A cost comparison between Combunox� and other combination analgesics is outlined in Table 2.

In summary, Combunox� is a new oxycodone plus ibuprofen combination analgesic agent for the short-term management of acute pain. Because Combunox� is significantly more expensive than acetaminophen based combination analgesics, it is likely to be a second line agent, reserved for patients that either do not tolerate or do not adequately respond to opioid plus acetaminophen combinations.

It is always good that they are working on more effective pain relievers. Sounds like this is a good alternative to percocet and percodan, and maybe even more effective. However, still being a schedule II, I am sure it will be very difficult to have it prescribed instead of hydrocodone products. If doctors are so skittish about Schedule IIIs', it will still be hard to get a "new" schedule II. Isn't it an upside down world when the efficacy of a drug treatment is dictated by the government's (i.e. DEA's) scheduling of a drug? Lunacy.
PB