Combunox

Combunox^® is the first and only product to combine 5 mg of oxycodone HCl and 400 mg of the nonsteroidal anti-inflammatory (NSAID) ibuprofen, the highest dose of ibuprofen available in a combination opioid product.

Combunox is indicated for the short-term (no more than 7 days) management of acute, moderate to severe pain. Dosage should not exceed 4 tablets in a 24-hour period. Supplied in a fixed-dose combination tablet, Combunox effectively treats pain centrally and peripherally through complementary actions. Opioids work through the central nervous system to prevent pain messages from reaching and being perceived by the brain. NSAIDs, such as ibuprofen, primarily exert their effect peripherally and also have anti-inflammatory properties.

Acute pain begins suddenly, is short-lived, and has a physiologic function. Every year about 25 million Americans experience pain as a result of injury or surgery and nearly all patients undergoing surgery should receive opioids afterward. Untreated pain, or pain not in control, has a significant negative impact on the sufferers' quality of life. Acute pain is the most common reason why patients seek medical attention.

Important Safety Information

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 and can occur at any time during use and without warning symptoms. Patients with cardiovascular disease or risk factors and the elderly may be at greater risk (See WARNINGS in Prescribing Information).
Combunox^® is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (See WARNINGS in PI).

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 in PI).