(diclofenac sodium/misoprostol) Tablets
CONTRAINDICATIONS AND WARNINGS
ARTHROTEC CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL.
ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT
CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS.
UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS
ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE
ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also
PRECAUTIONS). ARTHROTEC SHOULD NOT BE TAKEN BY PREGNANT
WOMEN (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND
WARNED NOT TO GIVE THE DRUG TO OTHERS.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
• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may increase with
duration of use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater risk (see WARNINGS).
• ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting
of coronary artery bypass graft (CABG) surgery (see WARNINGS).
• NSAIDs cause an increased risk of serious