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

avkare - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. pregnancy category b. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response,

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

apotex corp. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. limitations of use safety and effectiveness of balsalazide beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. balsalazide disodium capsules is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [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, the active moiety of balsalazide, 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 effects observed after oral administration of balsalazide disodium in pregnant rats and rabbits during organogenesis at doses up to 2.4 and 4.7 times, respectively, the maximum recommended human dose (mrhd) (see data).   the estimated background risk of major birth defects and miscarriage for the indicated population 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 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 2,500 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, the active moiety of balsalazide, 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 were performed in rats and rabbits following administration of balsalazide during organogenesis at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the mrhd based on body surface area for the rat and rabbit, respectively, and revealed no adverse embryofetal developmental effects due to balsalazide disodium. 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 balsalazide to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for balsalazide and any potential adverse effects on the breastfed child from balsalazide or from the underlying maternal condition.   clinical considerations advise the caregiver to monitor breastfed infants for diarrhea.   data in published lactation studies, maternal mesalamine doses from various oral and rectal mesalamine 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 balsalazide disodium has been established for the treatment of mildly to moderately active ulcerative colitis in pediatric and adolescent patients 5 years to 17 years of age. use of balsalazide disodium for this indication is supported by evidence from adequate and well-controlled clinical studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 5 years to 17 years [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.2)]. based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day [see dosage and administration (2.2)].   the safety and effectiveness of balsalazide disodium capsules in pediatric patients below the age of 5 years have not been established.  clinical trials of balsalazide disodium did not include sufficient numbers of subjects aged 65 years and over 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., neutropenia and pancytopenia, in patients who were 65 years or older compared to younger patients taking mesalamine-containing products. balsalazide disodium is converted into mesalamine in the colon. monitor complete blood cell counts and platelet counts in elderly patients during treatment with balsalazide disodium. 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 balsalazide disodium 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 balsalazide disodium, which is converted to mesalamine, may be greater in patients with impaired renal function. evaluate renal function in all patients prior to initiation and periodically while on balsalazide disodium 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 balsalazide disodium capsules 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)

oceanside pharmaceuticals - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsule is indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this

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

hikma pharmaceuticals usa inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. limitations of use: safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [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, the active moiety of balsalazide, 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 wit

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

avpak - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. safety and effectiveness of balsalazide beyond 8 weeks in children (ages 5 to 17 years) and 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. pregnancy category b. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. it is not known whether balsalazide disodium is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when balsalazide is administered to a nursing woman. use of balsalazide disodium in pediatric and adolescent patients 5 to 17 years of age for the treatment of mildly to moderately active ulcerative colitis is supported by: - extrapolation of results from clinical studies that supported the approval of balsalazide disodium for adults. - a clinical trial of 68 patients ages 5 to 17 years comparing two doses of balsalazide disodium (6.75 g/day and 2.25 g/day), and - a pharmacokinetic study performed on a subset of the pediatric study population. [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)]. based on the limited data available, dosing can be initiated at either 6.75 or 2.25 g/day. safety and efficacy of balsalazide disodium in pediatric patients below the age of 5 years have not been established.

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

physicians total care, inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in adults. safety and effectiveness of balsalazide disodium capsules beyond 12 weeks in adults have not been established. patients with hypersensitivity to salicylates or to any of the components of balsalazide disodium capsules or balsalazide metabolites. hypersensitivity reactions may include, but are not limited to the following: anaphylaxis, bronchospasm, and skin reaction. pregnancy category b. reproduction studies were performed in rats and rabbits at oral doses up to 2 g/kg/day, 2.4 and 4.7 times the recommended human dose based on body surface area for the rat and rabbit, respectively, and revealed no evidence of impaired fertility or harm to the fetus due to balsalazide disodium. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clea

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

golden state medical supply, inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg - balsalazide disodium capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. limitations of use: safety and effectiveness of balsalazide disodium capsules beyond 8 weeks in pediatric patients 5 years to 17 years of age and 12 weeks in adults have not been established. balsalazide disodium capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the components of balsalazide disodium capsules or balsalazide metabolites [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, the active moiety of balsalazide, 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 adve

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

clinical solutions wholesale, llc - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg

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par pharmaceutical inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 1.1 g

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

mylan pharmaceuticals inc. - balsalazide disodium (unii: 1xl6bji034) (balsalazide - unii:p80al8j7zp) - balsalazide disodium 750 mg