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

micro labs limited - 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 warnin

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

preferred 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: risk summary diclofenac sodium and misoprostol delayed-release tablets are contraindicated in pregnant women [see contraindications ( 4)]. if a woman becomes pregnant while taking diclofenac sodium and misoprostol delayed-release tablets, 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 diclofenac sodium and miso

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

greenstone llc - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - diclofenac sodium/misoprostol 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)] . diclofenac sodium/misoprostol is contraindicated in the following patients: risk summary diclofenac sodium/misoprostol is contraindicated in pregnant women [see contraindications (4)] . if a woman becomes pregnant while taking diclofenac sodium/misoprostol, 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 diclofenac sodium/misoprostol in pregnant women; however, there is information available about the active drug components of diclofenac sodium/misoprostol, diclofenac sodium and misoprostol. administration of misoprostol to pregnan

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

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

dash pharmaceuticals llc - 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 diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). 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. 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. diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women. diclofenac sodium and misoprostol delayed-releas

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

blenheim pharmacal, inc. - 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 diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). 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. 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. diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women. diclofena

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

eagle pharmaceuticals, 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 diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). 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. 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. diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women. diclofenac sodium and misoprostol delayed-releas

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)

avkare - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - 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 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 )] ● 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 ( 5.7 , 5.8 )] ● in the

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

actavis pharma, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - 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