Combunox
Combunox™
(oxycodone HCl and ibuprofen) Tablets
Cardiovascular Risk
- 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™ is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
- 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).
DRUG DESCRIPTION
Each combination Combunox™ tablet contains:
Oxycodone HCl, USP 5 mg
Ibuprofen, USP 400 mg
Combunox 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 4,5a-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:
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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:
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Inactive ingredients in Combunox 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.
Generic Name: Oxycodone HCl and Ibuprofen
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Combunox
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