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

zydus pharmaceuticals (usa) inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 800 mg - mesalamine delayed-release tablets is indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use: safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. mesalamine delayed-release tablets is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated backgro

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

par pharmaceutical - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets, usp are indicated: - in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - for the prolongation of the remission period between acute attacks of ulcerative colitis. sulfasalazine tablets are contraindicated in: -  patients with intestinal or urinary obstruction, -  patients with porphyria as sulfonamides have been reported to precipitate an acute attack, -  patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates. none reported.

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

greenstone llc - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine delayed release tablets are indicated: sulfasalazine delayed release tablets are particularly indicated in patients with ulcerative colitis who cannot take uncoated sulfasalazine tablets because of gastrointestinal intolerance, and in whom there is evidence that this intolerance is not primarily the result of high blood levels of sulfapyridine and its metabolites, e.g., patients experiencing nausea and vomiting with the first few doses of the drug, or patients in whom a reduction in dosage does not alleviate the adverse gastrointestinal effects. in patients with rheumatoid arthritis or juvenile rheumatoid arthritis, rest and physiotherapy as indicated should be continued. unlike anti-inflammatory drugs, sulfasalazine delayed release tablets do not produce an immediate response. concurrent treatment with analgesics and/or nonsteroidal anti-inflammatory drugs is recommended at least until the effect of sulfasalazine delayed release tablets is apparent. sulfasalazine delayed release tablets are con

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

actavis pharma, inc. - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and b) for the prolongation of the remission period between acute attacks of ulcerative colitis. sulfasalazine tablets are contraindicated in: patients with intestinal or urinary obstruction, patients with porphyria as sulfonamides have been reported to precipitate an acute attack, patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates. none reported.

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

blenheim pharmacal, inc. - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets, usp are indicated: - in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - for the prolongation of the remission period between acute attacks of ulcerative colitis. sulfasalazine tablets are contraindicated in: -  patients with intestinal or urinary obstruction, -  patients with porphyria as sulfonamides have been reported to precipitate an acute attack, -  patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates. none reported.

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

aidarex pharmaceuticals llc - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets, usp are indicated: - in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - for the prolongation of the remission period between acute attacks of ulcerative colitis. sulfasalazine tablets are contraindicated in: -  patients with intestinal or urinary obstruction, -  patients with porphyria as sulfonamides have been reported to precipitate an acute attack, -  patients hypersensitive to sulfasalazine, its metabolites, sulfonamides, or salicylates. none reported.

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

avpak - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets are indicated: - in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - for the prolongation of the remission period between acute attacks of ulcerative colitis. sulfasalazine tablets are contraindicated in: patients with intestinal or urinary obstruction, patients with porphyria as sulfonamides have been reported to precipitate an acute attack, patients hypersensitive to sulfasalazine, its metabolites, sulfonamides or salicylates. none reported.

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

preferred pharmaceuticals, inc - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets are indicated: sulfasalazine tablets are contraindicated in: patients with intestinal or urinary obstruction, patients with porphyria as sulfonamides have been reported to precipitate an acute attack, patients hypersensitive to sulfasalazine, its metabolites, sulfonamides or salicylates. none reported.

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

nucare pharmaceuticals,inc. - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - sulfasalazine 500 mg - sulfasalazine tablets are indicated: - in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and - for the prolongation of the remission period between acute attacks of ulcerative colitis. sulfasalazine tablets are contraindicated in: patients with intestinal or urinary obstruction, patients with porphyria as sulfonamides have been reported to precipitate an acute attack, patients hypersensitive to sulfasalazine, its metabolites, sulfonamides or salicylates. none reported.

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

american health packaging - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 800 mg - mesalamine delayed-release tablets is indicated for the treatment of moderately active ulcerative colitis in adults. limitations of use: safety and effectiveness of mesalamine delayed-release tablets beyond 6 weeks have not been established. mesalamine delayed-release tablets is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions ( 5.3), adverse reactions ( 6.2), and description ( 11)] . risk summary limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the es