Medications and Drugs
Pharmacy Editor: Jay W. Marks, MD
GENERIC NAME: diclofenac and misoprostol
BRAND NAME: Arthrotec
DRUG CLASS AND MECHANISM: 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.
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.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Tablets (diclofenac/misoprostol): Arthrotec 50 (50 mg/200 µg) ,
Arthrotec 75 (75 mg/200 µg) .
STORAGE: The tablets should be kept at room temperature, 15-30°C (59-86°F).
PRESCRIBED FOR: Arthrotec is used for treating signs and symptoms of
rheumatoid arthritis or osteoarthritis in patients at risk for developing ulcers
from NSAIDs.
DOSING: 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. 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.
DRUG INTERACTIONS: (Please also see the monographs 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. Patients taking lithium can develop toxic blood
levels of lithium because diclofenac may inhibit the elimination of lithium from
the body by the kidney. Side effects from methotrexate and cyclosporine also may
be increased by diclofenac. Diclofenac may reduce the effectiveness of
antihypertensives because it causes or worsens high blood pressure.
PREGNANCY: Since misoprostol can cause abortions, Arthrotec should not be
used by women who are pregnant. Avoid pregnancy for 1 month or 1 menstrual cycle
after discontinuing Arthrotec.
NURSING MOTHERS: Arthrotec is not recommended for use by nursing mothers.
SIDE EFFECTS: Arthrotec has the side effects of diclofenac and misoprostol.
The most common side effects are stomach pain, diarrhea, dyspepsia, nausea and
flatulence. 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. Serious side effects include gastrointestinal ulcers and bleeding;
liver dysfunction; severe skin reactions. 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.
References Facts and Comparisons 4.0. Online Edition Arthrotec
prescribing information. Pfizer Inc., 2005
Reference: FDA Prescribing Information
Last Editorial Review: 12/13/2005
Report Problems to the Food and Drug Administration
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.
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