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- What is diclofenac and misoprostol, and how does it work (mechanism of action)?
- What are the side effects of diclofenac and misoprostol?
- What is the dosage for diclofenac and misoprostol?
- Which drugs or supplements interact with diclofenac and misoprostol?
- Is diclofenac and misoprostol safe to take if I'm pregnant or breastfeeding?
- What else should I know about diclofenac and misoprostol?
What is diclofenac and misoprostol, and how does it work (mechanism of action)?
Arthrotec is a combination of diclofenac and misoprostol. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) similar to ibuprofen (Motrin or Advil), naproxen (Naprosyn), and others that is used to treat inflammation, pain, and fever. Diclofenac, like other NSAIDs works by inhibiting the production of prostaglandins. Prostaglandins are a family of chemicals produced by the cells of the body that promote inflammation, pain, and fever. In addition, they 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. Misoprostol is a synthetic (man-made) prostaglandin that stimulates secretion of mucus in the gastrointestinal tract. Mucus protects the lining of the stomach from acid. Misoprostol has been shown to reduce the frequency of ulcers of the stomach caused by NSAIDs. Arthrotec was approved by the FDA in December 1997.
What brand names are available for diclofenac and misoprostol?
Is diclofenac and misoprostol available as a generic drug?
Do I need a prescription for diclofenac and misoprostol?
What are the side effects of diclofenac and misoprostol?
Arthrotec has the side effects of diclofenac and misoprostol. The most common side effects are:
Diarrhea and abdominal pain may resolve after 2-7 days. Magnesium containing antacids worsen diarrhea caused by misoprostol. Taking Arthrotec with food and avoiding antacids containing magnesium may reduce the occurrence of diarrhea.
Other important side effects include
- gastrointestinal ulcers and bleeding;
- liver dysfunction;
- severe skin reactions,
- allergic reactions, and
- kidney failure.
Severe bronchospasms may occur in patients with aspirin-sensitive asthma. Like other NSAIDS, Arthrotec may cause heart attacks and strokes; accumulation of fluid and worsen heart failure; cause or worsen hypertension and kidney failure.
What is the dosage for diclofenac and misoprostol?
For osteoarthritis the recommended dose is Arthrotec 50 given three times daily. Patients who cannot tolerate this regimen may be treated with Arthrotec 50 or 75 twice daily. The recommended dose for treating rheumatoid arthritis is Arthrotec 50 given 3-4 times daily. If this regimen is not tolerated, Arthrotec 50 or 75 twice a day may be used. Administering Arthrotec twice daily is less effective for preventing ulcers. Taking Arthrotec with food may reduce stomach upset. It is recommended that Arthrotec not be taken with alcohol because of the increased risk for ulcers.
Which drugs or supplements interact with diclofenac and misoprostol?
(Please also see the drug information for diclofenac.) Diclofenac is generally used with caution in patients taking blood thinning medications (anticoagulants), such as warfarin (Coumadin), because of the increased risk of bleeding.
Antacids reduce the absorption of misoprostol and may delay absorption of diclofenac. Magnesium-containing antacids worsen misoprostol-associated diarrhea. Therefore, Arthrotec should not be administered with magnesium-containing antacids.
Combining NSAIDs with angiotensin receptor blockers (for example, valsartan [Diovan], losartan [Cozaar], irbesartan [Avapro]) or angiotensin converting enzyme inhibitors (for example, enalapril [Vasotec], captopril [captopril]) in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure. These effects usually are reversible.
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Is diclofenac and misoprostol safe to take if I'm pregnant or breastfeeding?
Diclofenac and misoprostol are secreted in breast milk. Arthrotec is not recommended for use by nursing mothers.
What else should I know about diclofenac and misoprostol?
What preparations of diclofenac and misoprostol are available?
Tablets (diclofenac/misoprostol): Arthrotec 50 (50 mg/200 g), Arthrotec 75 (75 mg/200 g) .
How should I keep diclofenac and misoprostol stored?
The tablets should be kept at room temperature, 15 C - 30 C (59 F - 86 F).
Diclofenac and misoprostol (Arthrotec) is a NSAID drug prescribed for the treatment of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Side effects, drug interactions, warnings and precautions, and pregnancy safety should be reviewed prior to taking this medication.
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Related Disease Conditions
Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body. Because it can affect multiple other organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease. The 16 characteristic early RA signs and symptoms include the following. Anemia Both sides of the body affected (symmetric) Depression Fatigue Fever Joint deformity Joint pain Joint redness Joint stiffness Joint swelling Joint tenderness Joint warmth Limping Loss of joint function Loss of joint range of motion Many joints affected (polyarthritis)
Ankle Pain (Tendonitis)
Ankle pain is commonly due to a sprain or tendinitis. The severity of ankle sprains ranges from mild (which can resolve within 24 hours) to severe (which can require surgical repair). Tendinitis of the ankle can be caused by trauma or inflammation.
Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Also known as degenerative arthritis, osteoarthritis can be caused by aging, heredity, and injury from trauma or disease.
Bursitis of the knee results when any of the three fluid-filled sacs (bursae) become inflamed due to injury or strain. Symptoms and signs include pain, swelling, warmth, tenderness, and redness. Treatment of knee bursitis depends on whether infection is involved. If the knee bursa is not infected, knee bursitis may be treated with ice compresses, rest, and anti-inflammatory and pain medications.
Shoulder bursitis is inflammation of the shoulder bursa. Bursitis may be caused by injury, infection, or a rheumatic condition. Symptoms include pain, swelling, tenderness, and pain with movement of the shoulder joint. Treatment may involve ice compresses, rest, and anti-inflammatory medications and depends on whether there is an infection.
Treatment & Diagnosis
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Facts and Comparisons 4.0. Online Edition Arthrotec prescribing information. Pfizer Inc., 2005.
Arthrotec FDA Prescribing Information, 2010