Eagle diclofenac sodium misoprostol is a tablet available in 50-mg and 75-mg strengths.13

Indication

Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.13

Diclofenac misoprostol is currently marketed in the U.S. by Eagle Pharmaceuticals, Inc. To report product quality concerns or drug safety issues, including adverse events, please contact Eagle at: 1-855-318-2170

For full Prescribing Information see the package insert.

Important Safety Information

Diclofenac sodium and misoprostol. Administration of misoprostol to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion beyond the eighth week of pregnancy (see also PRECAUTIONS). Diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). Patients must be advised of the abortifacient property and warned not to give the drug to others. Diclofenac sodium and misoprostol delayed release tablets should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID (see WARNINGS). In such patients, diclofenac sodium and misoprostol delayed-release tablets may be prescribed if the patient:

  • Has had a negative serum pregnancy test within 2 weeks prior to beginning therapy
  • Is capable of complying with effective contraceptive measures
  • Has received both oral and written warnings of the hazards of misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake
  • May begin diclofenac sodium and misoprostol delayed-release tablets only on the second or third day of the next normal menstrual period

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)
  • Diclofenac sodium and misoprostol delayed-release tablets are contraindicated for treatment of perioperative 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).