United States - English - NLM (National Library of Medicine)

nivagen pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium and misoprostol delayed-release tablets are 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)] . diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: - pregnancy. use of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, 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

United States - English - NLM (National Library of Medicine)

proficient rx lp - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in 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 (5.2)] . diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: risk summary diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women [see contraindications (4)] . there are no adequate and well-controlled studies of diclofenac sodium and misoprostol delayed-release tablets in pregnant women; however, there is information available about the active drug components of diclofenac sodium and misoprostol delayed-release tablets, diclofenac sodium and misoprostol. administration of misoprostol to pregnant women can cause abort

Canada - English - Health Canada

sandoz canada incorporated - diclofenac sodium; misoprostol - tablet - 50mg; 200mcg - diclofenac sodium 50mg; misoprostol 200mcg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

sandoz canada incorporated - diclofenac sodium; misoprostol - tablet - 75mg; 200mcg - diclofenac sodium 75mg; misoprostol 200mcg - other nonsteroidal antiimflammatory agents

United States - English - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in 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 (5.2)] . arthrotec is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium/misoprostol, other prostaglandins, or any components of the drug product [see warnings and precautions (5.7, 5.9)] known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium/misoprostol, other prostaglandins, or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids

United States - English - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 75 mg - carefully consider the potential benefits and risks of arthrotec and other treatment options before deciding to use arthrotec. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. see warnings, gastrointestinal effects - risk of ulceration, bleeding, and perforation for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications. see boxed contraindications and warnings related to misoprostol. arthrotec should not be taken by pregnant women. arthrotec is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. arthrotec should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after

United States - English - NLM (National Library of Medicine)

rebel distributors corp. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 75 mg - carefully consider the potential benefits and risks of arthrotec and other treatment options before deciding to use arthrotec. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. see warnings, gastrointestinal effects - risk of ulceration, bleeding and perforation for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications. see boxed contraindications and warnings related to misoprostol. arthrotec should not be taken by pregnant women. arthrotec is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. arthrotec should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - carefully consider the potential benefits and risks of arthrotec and other treatment options before deciding to use arthrotec. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. see warnings, gastrointestinal effects - risk of ulceration, bleeding, and perforation for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications. see boxed contraindications and warnings related to misoprostol. arthrotec should not be taken by pregnant women. arthrotec is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. arthrotec should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after

United States - English - NLM (National Library of Medicine)

stat rx usa llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 75 mg - carefully consider the potential benefits and risks of arthrotec and other treatment options before deciding to use arthrotec. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. see warnings, gastrointestinal effects - risk of ulceration, bleeding, and perforation for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications. see boxed contraindications and warnings related to misoprostol. arthrotec should not be taken by pregnant women. arthrotec is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. arthrotec should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after

United States - English - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - 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 contraindicated in the following patients: risk summary arthrotec is contraindicated in pregnant women [see contraindications (4)]. if a woman becomes pregnant while taking arthrotec, discontinue the drug and advise the woman of the potential risks to her and to a fetus. there are no adequate and well-controlled studies of arthrotec in pregnant women; however, there is information available about the active drug components of arthrotec, diclofenac sodium and misoprostol. administration of misoprostol to pregnant women can cause uterine rupture, abortion, premature birth, or birth defects [see warnings and precautions (5.1)] . co