No

Nonsteroidal Anti-Inflammatory Agent (NSAID); Prostaglandin

The diclofenac component is indicated for the treatment of osteoarthritis and rheumatoid arthritis; the misoprostol component is indicated for the prophylaxis of NSAID-induced gastric and duodenal ulceration

X

Pregnancy; patients who have demonstrated hypersensitivity to diclofenac, aspirin, other NSAIDs, misoprostol, other prostaglandins, or any component of the drug product

Use in premenopausal women; should not be used in premenopausal women unless they use effective contraception and have been advised of the risks of taking the product if pregnant

>10%: Gastrointestinal: Abdominal pain (21%), diarrhea (19%), nausea (11%), dyspepsia (14%)

1% to 10%:

Endocrine & metabolic: Elevated transaminase levels

Gastrointestinal: Flatulence (9%)

Hematologic: Anemia

Miscellaneous: Anaphylactic reactions

Increased effect/toxicity: Aspirin (shared toxicity), digoxin (elevated digoxin levels), warfarin (synergistic bleeding potential), methotrexate (increased methotrexate levels), cyclosporine (increased nephrotoxicity), lithium (increased lithium levels)

Decreased effects: Aspirin (displaces diclofenac from binding sites), antihypertensive agents (decreased blood pressure control), antacids (may decrease absorption)

See individual agents

The pharmacokinetic profiles of diclofenac and misoprostol administered as a combination product is similar to the profiles when the two drugs are administered as separate tablets. No pharmacokinetic interaction between the two drugs has been observed following multiple doses.

Adults: Oral:

Osteoarthritis: 1 tablet 2-3 times/day

Rheumatoid arthritis: 1 tablet 3-4 times/day

For both regimens, if not tolerated by patient, the dose may be reduced to 1 tablet twice daily

Arthrotec® 75:

Patients who cannot tolerate full daily Arthrotec® 50 regimens: 1 tablet twice daily

Note: The use of these tablets may not be as effective at preventing GI ulceration

May cause nervousness or dizziness; may rarely cause depression

May rarely cause agranulocytosis; use caution with clozapine and carbamazepine; may decrease the clearance of lithium resulting in elevated serum levels and potential toxicity; monitor serum lithium levels

No information available to require special precautions

No effects or complications reported

See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. Male: Do not cause a female to become pregnant. Male/female: Consult prescriber for instruction on appropriate contraceptive measures. This drug may cause severe fetal defects. Do not breast-feed.

Tablet: Diclofenac 50 mg and misoprostol 200 mcg; diclofenac 75 mg and misoprostol 200 mcg