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
Diclofenac Sodium 50 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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