What You Need to Know About Arthrotec (diclofenac/misprostol)

Arthrotec is a nonsteroidal anti-inflammatory drug (NSAID). Drugs classified as NSAIDs work by inhibiting the production of prostaglandins. Drugs classified as NSAIDs have anti-inflammatory, analgesic, and antipyretic properties.

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 mucus in the gastrointestinal tract.

Arthrotec is not available over-the-counter. Arthrotec requires a prescription from your doctor. No generic is yet available for Arthrotec. It is currently only available in brand name formulation. Arthrotec is distributed by Pfizer Inc.

Arthrotec is available in tablet form. Arthrotec comes in two strengths:

• Arthrotec 50 (50 mg diclofenac sodium and 200 mcg misoprostol)
• Arthrotec 75 (75 mg diclofenac sodium and 200 mcg misoprostol)

Arthrotec is indicated for the treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk for NSAID-induced gastric or duodenal ulcers.

Recommended dosage for osteoarthritis and maximum gastrointestinal (GI) protection is Arthrotec 50 TID. If not well-tolerated, Arthrotec 75 or Arthrotec 50 BID can be used, but with less GI protection. Check Prescription Abbreviations for BID, TID, QID.

The recommended dose for rheumatoid arthritis patients is Arthrotec 50 TID or QID. For patients who do not tolerate that dosage well, they can switch to Arthrotec 75 BID or Arthrotec 50 BID but will have less protection against ulcers.

The total dose of misoprostol should not exceed 800mcg/day. and no more than 200mcg at any one time. Doses of diclofenac higher than 150 mg/day for osteoarthritis patients are not recommended. Doses of diclofenac higher than 225 mg/day for rheumatoid arthritis patients are not recommended.

Other important instructions about taking Arthrotec include:

• Take Arthrotec with food.
• Never crush or split Arthrotec. It must be taken whole.
• Avoid alcohol when taking Arthrotec.
• Misoprostol can cause abortions. Women who are pregnant should not take Arthrotec.
• After discontinuing Arthrotec, do not get pregnant for one month, or one menstrual cycle after discontinuing the drug.
• Arthrotec is not recommended for mothers who are nursing their babies.

Arthrotec has the side effects associated with both of its components (diclofenac sodium and misoprostol).

• stomach pain
• dyspepsia
• nausea
• flatulence
• diarrhea (which may resolve in up to 7 days)
• bleeding gastrointestinal ulcers

There is a cardiovascular risk and gastrointestinal risk with Arthrotec, the same as is associated with all NSAIDs.

The following are serious enough to notify your doctor immediately:

• Signs of GI bleeding
• Skin rash (Stevens-Johnson Syndrome)
• Kidney failure
• Weight gain/swelling/edema
• Liver toxicity
• Anaphylactoid reaction (difficulty breathing)