ARTHROTEC® Contraindications

(misoprostol, diclofenac sodium)

4 CONTRAINDICATIONS

ARTHROTEC is contraindicated in the following patients:

•
Pregnancy. Use of misoprostol, a component of ARTHROTEC, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]
•
In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2)]
•
Active gastrointestinal bleeding [see Warnings and Precautions (5.3)]
•
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.8, 5.9)]
•
Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium and misoprostol, other prostaglandins, or any components of the drug product [see Warnings and Precautions (5.8, 5.10)]

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Contraindications

4 CONTRAINDICATIONS

ARTHROTEC is contraindicated in the following patients:

•
Pregnancy. Use of misoprostol, a component of ARTHROTEC, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]
•
In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.2)]
•
Active gastrointestinal bleeding [see Warnings and Precautions (5.3)]
•
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.8, 5.9)]
•
Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium and misoprostol, other prostaglandins, or any components of the drug product [see Warnings and Precautions (5.8, 5.10)]
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