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

akorn - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 10 mg in 1 ml - drug-induced methemoglobinemia. methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

general injectables & vaccines, inc - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 10 mg in 1 ml - drug induced methemoglobinemia. methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

american regent, inc. - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 5 mg in 1 ml - provayblue is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. provayblue is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions (5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions (5.3, 5.4)]. risk summary provayblue may cause fetal harm when administered to a pregnant woman. intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. following administration of provayblue to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. data animal data methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. maternal toxicity consisted of increased spleen weight. embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. the dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. maternal death was observed at the methylene blue dose of 100 mg/kg. embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. the dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. risk summary there is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions including genotoxicity, discontinue breast-feeding during and for up to 8 days after treatment with provayblue [see clinical pharmacology (12.3)] . the safety and effectiveness of provayblue for the treatment of acquired methemoglobinemia have been established in pediatric patients. use of provayblue is supported by two retrospective case series that included 2 pediatric patients treated with provayblue and 12 treated with another methylene blue class product. the case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). the efficacy outcomes were consistent across pediatric and adult patients in both case series [see clinical studies (14)]. clinical studies of provayblue did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. provayblue is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see dosage and administration (2)] . methylene blue concentrations increased in subjects with renal impairment (egfr 15 to 89 ml/min/1.73m2 ) significantly [see clinical pharmacology (12.3)] . adjust provayblue dosage in patients with moderate or severe renal impairment (egfr 15 to 59 ml/min/1.73 m2 ) [see dosage and administration (2.2)] . no dose adjustment is recommended in patients with mild renal impairment (egfr 60 – 89 ml/min/1.73 m2 ). methylene blue is extensively metabolized in the liver. monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with provayblue.

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

zydus pharmaceuticals usa inc. - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. methylene blue is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions (5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions (5.3, 5.4)]. risk summary methylene blue may cause fetal harm when administered to a pregnant woman. intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. following administration of methylene blue to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. data animal data methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. maternal toxicity consisted of increased spleen weight. embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. the dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. maternal death was observed at the methylene blue dose of 100 mg/kg. embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. the dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. risk summary there is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions, including genotoxicity discontinue breast-feeding during and for up to 8 days after treatment with methylene blue [see clinical pharmacology (12.3)] . the safety and effectiveness of methylene blue for the treatment of acquired methemoglobinemia have been established in pediatric patients. use of methylene blue is supported by two retrospective case series that included 2 pediatric patients treated with methylene blue and 12 treated with another methylene blue class product. the case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). the efficacy outcomes were consistent across pediatric and adult patients in both case series [see clinical studies (14)] . clinical studies of methylene blue did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. methylene blue is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see dosage and administration (2)]. methylene blue concentrations increased in subjects with renal impairment (egfr 15 to 89 ml/min/1.73 m2 ) significantly [see clinical pharmacology (12.3)]. adjust methylene blue dosage in patients with moderate or severe renal impairment (egfr 15 to 59 ml/min/1.73 m2 ) [see dosage and administration (2.2)]. no dose adjustment is recommended in patients with mild renal impairment (egfr 60-89 ml/min/1.73 m2 ). methylene blue is extensively metabolized in the liver. monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with methylene blue.

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

bpi labs llc - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - drug-induced methemoglobinemia methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions, and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

bpi labs llc - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - drug-induced methemoglobinemia methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions, and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

cenexi hsc - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - provayblue ® usp is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. this indication is approved under accelerated approval. continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials [ see clinical studies ( 14.1) ]. provayblue ® is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions ( 5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions ( 5.3,

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

edwards pharmaceuticals, inc. - methenamine (unii: j50oix95qv) (methenamine - unii:j50oix95qv), sodium phosphate, monobasic (unii: 3980jih2sw) (sodium cation - unii:lyr4m0nh37), methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh), hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x) - methenamine 81.6 mg - urogesic-blue™ is indicated for the treatment of symptoms of irritative voiding. indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. indicated for the relief of urinary tract symptoms caused by diagnostic procedures. urogesic-blue™ is contraindicated in patients with a hypersensitivity to any of the ingredients. risk-benefit should be considered when the following medical problems exist: cardiac disease (especially cardiac arrythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy). a dependence on the use of urogesic-blue™ has not been reported and due to the nature of its ingredients, abuse of urogesic-blue™ is not expected.

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

edwards pharmaceuticals, inc. - methenamine (unii: j50oix95qv) (methenamine - unii:j50oix95qv), sodium phosphate, monobasic (unii: 3980jih2sw) (sodium cation - unii:lyr4m0nh37), methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh), hyoscyamine sulfate (unii: f2r8v82b84) (hyoscyamine - unii:px44xo846x) - methenamine 81.6 mg - urogesic-blue™ is indicated for the treatment of symptoms of irritative voiding. indicated for the relief of local symptoms, such as hypermotility which accompany lower urinary tract infections and as antispasmodic. indicated for the relief of urinary tract symptoms caused by diagnostic procedures. urogesic-blue™ is contraindicated in patients with a hypersensitivity to any of the ingredients. risk-benefit should be considered when the following medical problems exist: cardiac disease (especially cardiac arrythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy). a dependence on the use of urogesic-blue™ has not been reported and due to the nature of its ingredients, abuse of urogesic-blue™ is not expected.

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

zydus lifesciences limited - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) -