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In addition to requiring new labeling on these prescript"...
(oxycodone hcl and ibuprofen) Tablets
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS).
- Combunox™ (oxycodone hcl and ibuprofen) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (See WARNINGS).
Each combination Combunox™ (oxycodone hcl and ibuprofen) tablet contains:
Oxycodone HCl, USP 5 mg
Ibuprofen, USP 400 mg
Combunox (oxycodone hcl and ibuprofen) is supplied in a fixed combination tablet form for oral administration and combines the opioid analgesic agent, oxycodone HCl, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.
Oxycodone HCl is a centrally acting semisynthetic opioid analgesic. Its chemical name is 4,5α-Epoxy-14-hydroxy-3-methoxy-methylmorphinan-6-one hydrochloride. Its chemical formula is C18H21NO4 HCl and molecular weight is 351.83. Its structural formula is:
Ibuprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Its chemical name is (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is C13H18O2 and molecular weight is 206.29. Its structural formula is:
Inactive ingredients in Combunox (oxycodone hcl and ibuprofen) tablets include: sodium starch glycolate, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, calcium stearate, carboxymethylcellulose, povidone, Opadry® II White, Y-22 7719 coloring agent. Opadry® II White, Y-22 7719 coloring agent consists of titanium dioxide, polydextrose, hypromellose, triacetin and polyethylene glycol 8000.
What are the possible side effects of ibuprofen and oxycodone (Combunox)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using ibuprofen and oxycodone and call your doctor at once if you have a serious side effect such as:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- shallow breathing, slow heartbeat;
What are the precautions when taking oxycodone hcl and ibuprofen (Combunox)?
Before taking this medication, tell your doctor or pharmacist if you are allergic to oxycodone or ibuprofen; or to other narcotic pain relievers (such as codeine, hydrocodone, oxymorphone); or to aspirin or other NSAIDs (such as naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), recent heart bypass surgery (CABG), liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count),...
Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.
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