Diclofenac Sodium 50 MG Misoprostol 0.2 MG Delayed Release Oral Tablet Arthrotec
1 INDICATIONS AND USAGE ARTHROTEC is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3) ] . ARTHROTEC is a combination of diclofenac sodium, a non-steroidal anti-inflammatory drug, and misoprostol, a prostaglandin-1 (PGE1) analog, indicated for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. ( 1 )
G.D. Searle LLC Division of Pfizer Inc
ROUND WHITE SEARLE 1411 AAAA 50
SEARLE 1411 AAAA 50 ROUND WHITE
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diclofenac sodium 75 MG misoprostol 0.2 MG Delayed Release Oral Tablet Arthrotec
G.D. Searle LLC Division of Pfizer Inc
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16 HOW SUPPLIED/STORAGE AND HANDLING ARTHROTEC (
DICLOFENAC SODIUM AND MISOPROSTOL delayed-release tablets) are supplied as: • 50 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with four "A's" encircling a "50" in the middle on one side and "SEARLE" and "1411" on the other. • 75 mg diclofenac sodium and 200 mcg misoprostol as round, biconvex, white to off-white tablets imprinted with four "A's" encircling a "75" in the middle on one side and "SEARLE" and "1421" on the other. The dosage strengths are supplied in: Strength NDC Number Size ARTHROTEC 50 50 mg diclofenac sodium and 200 mcg misoprostol 0025-1411-60 bottle of 60 0025-1411-90 bottle of 90 ARTHROTEC 75 75 mg diclofenac sodium and 200 mcg misoprostol 0025-1421-60 bottle of 60 Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
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