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

amring 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)] . 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 rectal suppositories, 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 rectal suppositories, 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 rectal suppositories 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 rectal suppositories and any potential adverse effects on the breastfed child from mesalamine rectal suppositories 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 rectal suppositories in pediatric patients for the treatment of mildly to moderately active ulcerative proctitis have not been established. mesalamine rectal suppositories were 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 rectal suppositories 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 rectal suppositories 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 rectal suppositories. 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 rectal suppositories [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 rectal suppository 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)] .

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

avkare - 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), and description ( 11)]. pregnancy category b 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 di

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

avkare - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine delayed-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. mesalamine is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine [ see warnings and precautions ( 5.3), description ( 11), adverse reactions ( 6.2) ] . 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 de

United States - English - 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.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

international pharmaceutical services sa-nv - mesalazine 250 mg - gastro-resistant tablet - 250 mg - mesalazine 250 mg - mesalazine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

international pharmaceutical services sa-nv - mesalazine 500 mg - gastro-resistant tablet - 500 mg - mesalazine 500 mg - mesalazine

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - mesalazine 500 mg - gastro-resistant tablet - 500 mg - mesalazine 500 mg - mesalazine

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

sandoz inc - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine suppositories, 1000 mg are 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 [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 miscarriage in

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

mylan pharmaceuticals inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. mesalamine extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of mesalamine extended-release capsules [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) . in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.7 and 5.4 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. 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. 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. 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 in 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, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. reproduction studies with mesalamine during organogenesis have been performed in rats at oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the recommended human dose based on a body surface area comparison) and have revealed no evidence of harm to the fetus due to mesalamine. 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 2% or less (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 extended-release capsules and any potential adverse effects on the breastfed child from mesalamine or from the underlying maternal condition. advise the caregiver to monitor the breastfed infant for diarrhea. 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 the 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. safety and effectiveness of mesalamine extended-release capsules in pediatric patients have not been established. clinical studies of mesalamine extended-release capsules did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. 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 extended-release capsules. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine extended-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 extended-release capsules [see use in specific populations (8.6)] . mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine extended-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 extended-release capsules if renal function deteriorates while on therapy [see warnings and precautions (5.1), adverse reactions (6.2), drug interactions (7.2)] .

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

oceanside pharmaceuticals - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. mesalamine extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of mesalamine extended-release capsules [ 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) . in animal reproduction studies, there were no adverse developmental outcomes with administration of oral mesalamine during organogenesis to pregnant rats and rabbits at doses 1.7 and 5.4 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. 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. 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 in 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, and 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 oral doses up to 320 mg/kg/day (about 1.7 times the recommended human dose based on a body surface area comparison) and rabbits at doses up to 495 mg/kg/day (about 5.4 times the 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 2% or less (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 extended-release capsules 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 extended-release capsules and any potential adverse effects on the breastfed child from mesalamine extended-release capsules 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 the 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. safety and effectiveness of mesalamine extended-release capsules in pediatric patients have not been established. clinical studies of mesalamine extended-release capsules did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. 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 extended-release capsules. monitor complete blood cell counts and platelet counts in elderly patients during treatment with mesalamine extended-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 extended-release capsules [ see use in specific populations (8.6)] . mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on mesalamine extended-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 extended-release capsules if renal function deteriorates while on therapy [ see warnings and precautions (5.1) , adverse reactions (6.2), drug interactions (7.2)] .