FDA Approves GD Searle's Arthortec

Arthrotec is a tablet containing a combination of diclofenac and misoprostol.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain.

Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs.

Arthrotec is used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.

Arthrotec is a combination of diclofenac and misoprostol. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) similar to ibuprofen (Motrin; Advil), naproxen (Naprosyn), and others. Diclofenac, like other NSAIDs work by inhibiting the production of prostaglandins. Prostaglandins are a related family of chemicals that are produced by the cells of the body and have several important functions. They promote inflammation, pain, and fever, support the function of platelets that are necessary for the clotting of blood, and protect the lining of the stomach from the damaging effects of acid. Prostaglandins are produced by the enzyme cyclooxygenase (Cox). There actually are two Cox enzymes, Cox-1 and Cox-2. Both enzymes produce prostaglandins that promote inflammation, pain, and fever. However, only Cox-1 produces prostaglandins that support platelets and protect the stomach. Diclofenac blocks both Cox enzymes and reduces prostaglandins throughout the body. As a consequence, ongoing inflammation, pain, and fever are reduced. Since prostaglandins that protect the stomach and support platelets and blood clotting also are reduced, NSAIDs can cause ulcers in the stomach and promote bleeding.

Arthrotec is a combination drug of diclofenac and misoprostol. Diclofenac blocks COX-1 and COX-2 enzymes which produce prostaglandins and play a role in the inflammatory process. COX-1 also is involved in platelet function and stomach protection.
Diclofenac is the nonsteroidal anti-inflammatory (NSAID) portion of Arthrotec. Misoprostol (a synthetic prostaglandin) protects the lining of the stomach by reducing acid production and stimulates secretion of mucous in the gastrointestinal tract.

Arthrotec has been approved as a treatment for arthritis pain. It is a non-steroidal anti-inflammatory (diclofenac sodium) that is coated with misoprostol (for protection against stomach ulcer).