Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

greenstone llc - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine is indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. mesalamine is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [ s ee 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 evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose ( see data ) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data reproduction studies have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human intra-rectal dose of mesalamine, based on body surface area) and in rabbits at oral doses up to 495 mg/kg/day (about 5.4 times the recommended human intra-rectal dose of mesalamine, based on body surface area) following administration during the period of organogenesis, and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. risk summary mesalamine and its n-acetyl metabolite are present in human milk in undetectable to small amounts ( see data ) . there are limited reports of diarrhea in breastfed infants. there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of mesalamine to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine and any potential adverse effects on the breastfed child from mesalamine or from the underlying maternal conditions.   clinical considerations monitor breastfed infants for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. the concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/l. the concentration of the n-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of n-acetyl-5-aminosalicylic acid. the safety and effectiveness of mesalamine in pediatric patients for the treatment of mildly to moderately active ulcerative proctitis have not been established. mesalamine was evaluated for the treatment of ulcerative proctitis in a 6-week, open-label, single-arm study in 49 patients 5 to 17 years of age, which only included 14 patients with histologically-confirmed cases of ulcerative proctitis. however, efficacy was not demonstrated. adverse reactions seen in pediatric patients in this trial (abdominal pain, headache, pyrexia, pharyngolaryngeal pain, diarrhea and vomiting) were similar to those seen in adult patients. clinical trials of mesalamine did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients.   reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia and pancytopenia) in patients receiving mesalamine-containing products such as mesalamine who were 65 years or older compared to younger patients. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients when prescribing mesalamine [see use in specific populations ( 8.6 )] . mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue mesalamine if renal function deteriorates while on therapy [see warnings and precautions ( 5.1 ), adverse reactions (6.2 ) , drug interactions ( 7.1 )] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release tablets are indicated for the: pediatric use information is approved for takeda pharmaceuticals u.s.a., inc.’s lialda (mesalamine) delayed-release tablets. however, due to takeda pharmaceuticals u.s.a., inc.’s marketing exclusivity rights, this drug product is not labeled with that information. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), description (11)] . published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations) . in animal reprodu

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine rectal suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. mesalamine rectal suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [see warnings and precautions (5.3), adverse reactions (6.2), and description (11)] . limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. no evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risk of major birth defects and miscarr

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

american health packaging - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release tablets are 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 are 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. there was no evidence of harm to the fetus. these mesalamine doses were about 0.97 times (rat) and 1.95 times (rabbit) the recommended human dose of 4.8 grams per day, based on body surface area. risk summary mesalamine and its n-acetyl metabolite are present in human milk in undetectable to small amounts [see data]. there are limited reports of diarrhea in breastfed infants. there is no information on the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mesalamine and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. clinical considerations monitor breastfed infants for diarrhea. data human data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. the concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/l. the concentration of the nacetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of n-acetyl-5-aminosalicylic acid. safety and effectiveness of mesalamine in pediatric patients have not been established. see the prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients. clinical studies of mesalamine delayed-release tablets did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, and pancytopenia) in patients who were 65 years or older compared to younger patients taking mesalamine containing products such as mesalamine delayed-release tablets, 800 mg. monitor complete blood cell counts and platelet counts in elderly patients during therapy with mesalamine delayed-release tablets. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing mesalamine delayed-release tablets [see use in specific populations (8.6)]. mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine delayed-release tablets therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue mesalamine if renal function deteriorates while on therapy [see warnings and precautions (5.1), drug interactions (7.1)and adverse reactions (6.2)].

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release tablets are indicated for the: - induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. - treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [ see warnings and precautions (5.3), adverse reactions (6.2), description (11)] . risk summary published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data ). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations) . in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.8 and 2.9 times, respectively, the maximum recommended human dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and embryo/fetal risk published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. data human data published data from meta-analyses, cohort studies, and case series on the use of mesalamine during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. there is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk of major congenital malformations, including cardiac malformations. published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. animal data reproduction studies with mesalamine during organogenesis have been performed in rats at doses up to 1000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine. risk summary data from published literature report the presence of mesalamine and its metabolite, n-acetyl-5-aminosalicylic acid in human milk in small amounts with relative infant doses (rid) of 0.1% or less for mesalamine (see data) . there are case reports of diarrhea in breastfed infants exposed to mesalamine (see clinical considerations) . there is no information on the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of mesalamine to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine and any potential adverse effects on the breastfed child from mesalamine or from the underlying maternal condition. clinical considerations advise the caregiver to monitor the breastfed infant for diarrhea. data in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 4.8 g daily. the average concentration of mesalamine in milk ranged from non-detectable to 0.5 mg/l. the average concentration of n-acetyl-5-aminosalicylic acid in milk ranged from 0.2 to 9.3 mg/l. based on these concentrations, estimated infant daily dosages for an exclusively breastfed infant are 0 to 0.075 mg/kg/day (rid 0% to 0.1%) of mesalamine and 0.03 to 1.4 mg/kg/day of n-acetyl-5-aminosalicylic acid. the safety and effectiveness of mesalamine has been established for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. use of mesalamine in this population is supported by evidence from adequate and well-controlled trials in adults, a multicenter, randomized, double-blind, parallel group trial in 105 pediatric patients 5 to 17 years of age, and additional pharmacokinetic analyses. the safety profile in pediatric patients was similar to that observed in adults [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.2)]. the safety and effectiveness of mesalamine has not been established in patients weighing less than 24 kg. clinical trials of mesalamine did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, and pancytopenia) in patients who were 65 years or older who were taking mesalamine-containing products such as mesalamine compared to younger patients. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine. systemic exposures are increased in elderly subjects [see clinical pharmacology (12.3)] . in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing mesalamine. consider starting at the low end of the dosing range for induction in elderly patients [see dosage and administration (2), use in specific populations (8.6)] . mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue mesalamine delayed-release tablets if renal function deteriorates while on therapy [see warnings and precautions (5.1), adverse reactions (6.2), drug interactions (7.1)] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

remedyrepack inc. - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

remedyrepack inc. - sulfasalazine (unii: 3xc8guz6cb) (sulfasalazine - unii:3xc8guz6cb) - 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.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. mesalamine delayed-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. mesalamine delayed-release capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release capsules [see warnings and precautions (5.3), adverse reactions (6.2),  description (11)] .  risk summary there are no adequate and well controlled studies of mesalamine use in pregnant women. limited published human data on mesalamine show no increase in the overall rate of congenital malformations. some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. furthermore, all pregnancies, regardless of drug exposure, h

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

greenstone llc - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release capsules is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. mesalamine delayed-release capsules is indicated for the maintenance of remission of ulcerative colitis in adults. mesalamine delayed-release capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release capsules [see warnings and precautions ( 5.3 ), adverse reactions ( 6.2 ), description ( 11 ) ] . risk summary there are no adequate and well controlled studies of mesalamine delayed-release capsules use in pregnant women. limited published human data on mesalamine show no increase in the overall rate of congenital malformations. some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease. furthermore, all pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. no evidence of fetal harm was observed in animal reproduction studies of mesalamine in rats and rabbits at oral doses approximately 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose. mesalamine delayed-release capsules should be used during pregnancy only if clearly needed. human data mesalamine crosses the placenta. in prospective and retrospective studies of over 600 women exposed to mesalamine during pregnancy, the observed rate of congenital malformations was not increased above the background rate in the general population. some data show an increased rate of preterm birth, stillbirth, and low birth weight, but it is unclear whether this was due to underlying maternal disease, drug exposure, or both, as active inflammatory bowel disease is also associated with adverse pregnancy outcomes. animal data reproduction studies with mesalamine were performed during organogenesis in rats and rabbits at oral doses up to 480 mg/kg/day. there was no evidence of impaired fertility or harm to the fetus. these mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area. mesalamine and its n-acetyl metabolite are present in human milk. in published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily. the concentration of mesalamine in milk ranged from non-detectable to 0.11 mg/l. the concentration of the n-acetyl-5-aminosalicylic acid metabolite ranged from 5 to 18.1 mg/l. based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 to 0.017 mg/kg/day of mesalamine and 0.75 to 2.72 mg/kg/day of n-acetyl-5-aminosalicylic acid. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mesalamine delayed-release capsules and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. caution should be exercised when mesalamine delayed-release capsules is administered to a nursing woman. the safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets. use of mesalamine delayed-release capsules in these pediatric age groups is supported by evidence from adequate and well controlled studies of mesalamine delayed-release 400 mg tablets in adults and a single 6-week study in 82 pediatric patients 5 to 17 years of age [see adverse reactions ( 6.1 ), clinical pharmacology ( 12.3 ) , clinical studies ( 14.1 )] .  the safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients below the age of 5 years have not been established. the safety and effectiveness of mesalamine delayed-release capsules in the maintenance of remission of ulcerative colitis in pediatric patients have not been established. clinical studies of mesalamine delayed-release tablets did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. reports from uncontrolled clinical studies and postmarketing experience suggest a higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) in subjects receiving mesalamine delayed-release tablets who are 65 years or older compared to younger patients taking mesalamine-containing products such as mesalamine delayed-release capsules. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine delayed-release capsules. in general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing mesalamine delayed-release capsules [see use in specific populations ( 8.6 )] . mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine delayed-release capsules therapy. monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. discontinue mesalamine delayed-release capsules if renal function deteriorates while on therapy  [see warnings and precautions ( 5.1 ) , adverse reactions ( 6.2 ) , drug interactions ( 7.1 ) ] .

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

rising pharmaceuticals, inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. mesalamine suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle [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 evidence of teratogenicity was observed in rats or rabbits when treated during gestation with orally administered mesalamine at doses greater than the recommended human intra-rectal dose [see data ]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. in the u.s. general population, the estimated background risk of major birth defects and m