• Horizon Pharma Products

DUEXIS® (ibuprofen and famotidine) Tablets

The Smarter Ibuprofen Due to Added Gastroprotection

DUEXIS (ibuprofen and famotidine) tablets 800 mg/26.6 mg are a proprietary, single-tablet combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the histamine H2-receptor antagonist famotidine. Ibuprofen has proven anti-inflammatory and analgesic properties, and famotidine reduces the stomach acid secretion that can cause gastric and duodenal ulceration. With the combination of ibuprofen and famotidine in a single product, DUEXIS decreases the risk of upper gastrointestinal (GI) ulcers while reducing pain and inflammation from osteoarthritis (OA) and rheumatoid arthritis (RA).

POWERFUL HERE Duexis outer layer: IBUPROFEN to relieve the pain and inflammation of osteoarthritis and rheumatoid arthritis. PROTECTION HERE DUEXIS inner core: FAMOTIDINE to decrease your risk of developing ulcers in the stomach or upper intestines. Not actual size; for illustrative purposes only.

Indications and Usage

DUEXIS is indicated for the relief of signs and symptoms of RA and OA and to decrease the risk of developing upper GI 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.

Important Safety Information

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, may increase the chance of a heart attack or stroke, which can be fatal. This chance increases with longer use and in people who have heart disease or risk factors for heart disease.
  • DUEXIS should not be used before or after a type of heart surgery called coronary artery bypass graft (CABG).
  • NSAID-containing medications like DUEXIS may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer. These problems can happen without warning and can lead to death. Older patients may have a greater chance of developing these problems.

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.

For more information on DUEXIS, please see the Medication Guide and Full Prescribing Information.

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