США - англійська - 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

США - англійська - NLM (National Library of Medicine)

unit dose services - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - misoprostol 200 ug - misoprostol is indicated for reducing the risk of nsaid (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. misoprostol tablet has not been shown to reduce the risk of duodenal ulcers in patients taking nsaids. misoprostol tablets should be taken for the duration of nsaid therapy. misoprostol tablets has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. it had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with nsaid use. see boxed warnings. misoprostol tablets should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (nsaids). misoprostol tablets should not be taken by anyone with a history of allergy to prosta

США - англійська - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - two 12-week, randomized, double-blind trials in osteoarthritic patients who had gastrointestinal symptoms but no ulcer on endoscopy while taking an nsaid compared the ability of 200 mcg of misoprostol tablets, 100 mcg of misoprostol tablets, and placebo to reduce the risk of gastric ulcer (gu) formation. patients were approximately equally divided between ibuprofen, piroxicam, and naproxen, and continued this treatment throughout the 12 weeks. the 200-mcg dose caused a marked, statistically significant reduction in gastric ulcers in both studies. the lower dose was somewhat less effective, with a significant result in only one of the studies. reduction of risk of gastric ulcers induced by ibuprofen, piroxicam, or naproxen [no. of patients with ulcer(s) (%)] in these trials there were no significant differences between misoprostol tablets and placebo in relief of day or night abdominal pain. no effect of misoprostol tablets in reducing the risk of duodenal ulcers was demonstrated, but relatively few duodenal l

США - англійська - NLM (National Library of Medicine)

pharmpak, inc. - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - two 12-week, randomized, double-blind trials in osteoarthritic patients who had gastrointestinal symptoms but no ulcer on endoscopy while taking an nsaid compared the ability of 200 mcg of misoprostol tablets, 100 mcg of misoprostol tablets, and placebo to reduce the risk of gastric ulcer (gu) formation. patients were approximately equally divided between ibuprofen, piroxicam, and naproxen, and continued this treatment throughout the 12 weeks. the 200-mcg dose caused a marked, statistically significant reduction in gastric ulcers in both studies. the lower dose was somewhat less effective, with a significant result in only one of the studies. reduction of risk of gastric ulcers induced by ibuprofen, piroxicam, or naproxen [no. of patients with ulcer(s) (%)] in these trials there were no significant differences between misoprostol tablets and placebo in relief of day or night abdominal pain. no effect of misoprostol tablets in reducing the risk of duodenal ulcers was demonstrated, but relatively few duodenal l

США - англійська - NLM (National Library of Medicine)

major pharmaceuticals - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - two 12-week, randomized, double-blind trials in osteoarthritic patients who had gastrointestinal symptoms but no ulcer on endoscopy while taking an nsaid compared the ability of 200 mcg of misoprostol tablets, 100 mcg of misoprostol tablets, and placebo to reduce the risk of gastric ulcer (gu) formation. patients were approximately equally divided between ibuprofen, piroxicam, and naproxen, and continued this treatment throughout the 12 weeks. the 200-mcg dose caused a marked, statistically significant reduction in gastric ulcers in both studies. the lower dose was somewhat less effective, with a significant result in only one of the studies. reduction of risk of gastric ulcers induced by ibuprofen, piroxicam, or naproxen                       [no. of patients with ulcer(s) (%)] therapy duration therapy 4 weeks 8 weeks 12 weeks study no. 1 misoprostol tablets 200 mcg q.i.d. (n=74) 1 (1.4) 1 (1.4) 1 (1.4) 1 (1.4) misoprostol tablets 100 mcg q.i.d. (n=77) 3 (3.9) 3 (3.9) 3 (3.9) 3 (3.9)

США - англійська - NLM (National Library of Medicine)

yung shin pharmaceutical industrual co., ltd. - 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: - 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 setting of coronary artery bypass g

США - англійська - 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

США - англійська - NLM (National Library of Medicine)

bryant ranch prepack - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - misoprostol 200 ug

США - англійська - NLM (National Library of Medicine)

cadila healthcare limited - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - misoprostol tablets are indicated for reducing the risk of nsaid (nonsteroidal anti-inflammatory drugs, including aspirin)– induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking nsaids. misoprostol should be taken for the duration of nsaid therapy. misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. it had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with nsaid use. see boxed warnings. misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (nsaids). misoprostol should not be taken by anyone with a history of allergy to prostaglandins.

США - англійська - NLM (National Library of Medicine)

genbiopro, inc. - misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - misoprostol is indicated for reducing the risk of nsaid (nonsteroidal anti-inflammatory drugs, including aspirin)–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking nsaids. misoprostol should be taken for the duration of nsaid therapy. misoprostol has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months' duration. it had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with nsaid use. see boxed warnings. misoprostol should not be taken by pregnant women to reduce the risk of ulcers induced by nonsteroidal anti-inflammatory drugs (nsaids). misoprostol should not be taken by anyone with a history of allergy to prostaglandins.