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Arthrotec Information:

Arhtortec (Diclofenac/Misoprotol) is a nonsteroidal anti-inflammatory agent (NSAID) and prostaglandin analog combination used to relieve joint pain, swelling, and stiffness caused by arthritis in patients at high risk of developing ulcers. ARTHROTEC is 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. ARTHROTEC is a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog. ARTHROTEC oral tablets are white to off-white, round, biconvex and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (ARTHROTEC 50) or 75 mg (ARTHROTEC 75) diclofenac sodium surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder.

Arthrotec Side Effects:

SIDE EFFECTS, that may go away during treatment, include nausea, vomiting, diarrhea, gas, upset stomach, dizziness, drowsiness, or headache. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience diarrhea which lasts longer than 1 week, trouble breathing, skin rash or hives, yellowing of the skin or eyes, dark urine, sore throat or fever, unusual bleeding or bruising, loss of appetite, weight loss, or vision or hearing problems. CONTACT YOUR DOCTOR IMMEDIATELY AND STOP TAKING THIS MEDICINE if you notice any of the following unlikely but very serious side effects: black stools, persistent stomach/abdominal pain, or vomit that looks like coffee grounds. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

ARTHROTEC (diclofenac sodium/misoprostol) ADMINISTRATION BY ANY ROUTE IS CONTRAINDICATED, BECAUSE ITS MISOPROSTOL COMPONENT CAN CAUSE ABORTION, IN WOMEN WHO ARE PREGNANT (See WARNINGS and PRECAUTIONS). • Anecdotal reports have been received, primarily from Brazil, of congenital anomalies and reports of fetal death in pregnancies in which misoprostol has been used as an abortifacient. PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED INTRAVAGINALLY IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE FIRST TRIMESTER OF PREGNANCY. UTERINE PERFORATION HAS BEEN REPORTED FOLLOWING ADMINISTRATION OF COMBINED VAGINAL-AND-ORAL MISOPROSTOL IN PREGNANT WOMEN TO INDUCE ABORTION. IN EACH OF THESE REPORTED CASES, THE GESTATIONAL AGE OF THE PREGNANCIES WAS UNKNOWN. ARTHROTEC 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, ARTHROTEC 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. • will begin ARTHROTEC only on the second or third day of the next normal menstrual period.