WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full Prescribing Information for complete boxed warning.

  • Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs, including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal (GI) adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.

Important Safety Information About DUEXIS

DUEXIS is not right for everyone. People who have had asthma, hives, or an allergic reaction to aspirin or other NSAIDs should not take DUEXIS. Women in the late stages of pregnancy should not take DUEXIS. People who have had allergic reactions to medications like famotidine (histamine H2‐receptor antagonists) should not take DUEXIS.

Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.

NSAID‐containing medications like DUEXIS can cause high blood pressure or make existing high blood pressure worse, either of which can increase the chance of a heart attack or stroke. Your health care provider should check your blood pressure while you are taking DUEXIS.

Before you start taking DUEXIS, tell your health care provider if you have heart problems, kidney problems, or liver problems, or if you are taking medications for high blood pressure. DUEXIS can increase the chance of potentially significant liver injury and/or kidney injury, which may be fatal. Stop taking DUEXIS immediately and contact your health care provider if you experience any signs and/or symptoms of liver or kidney injury.

Serious allergic reactions, including skin reactions, can happen without warning and can be life threatening. Stop taking DUEXIS and consult your doctor immediately if you get a skin rash or if you start to have problems breathing or swallowing, or if you develop swelling of your face or throat.

The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain, and headache.

Please see Medication Guide and full Prescribing Information on this Web site.

 

Indication for DUEXIS

DUEXIS, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.


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