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

sunrise pharmaceutical, inc - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - polyethylene glycol 3350 17 g in 17 g - osmotic laxative - relieves occasional constipation (irregularity) - generally produces a bowel movement in 1 to 3 days taking a prescription drug - you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. these may be signs of a serious condition. - you get diarrhea - you need to use a laxative for longer than 1 week

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

strides pharma inc - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - polyethylene glycol 3350 17 g in 17 g - osmotic laxative osmotic laxative - relieves occasional constipation (irregularity) - generally produces a bowel movement in 1 to 3 days

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

lannett company, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - polyethylene glycol 3350 17 g in 17 g - laxative - relieves occasional constipation (irregularity) - generally produces a bowel movement in 1 to 3 days

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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

natures best (tas) pty ltd - methylene blue - misc. fish tank medication - methylene blue dye-blue active 12.0 mg/ml - parasiticides - fish aquarium freshwater | cold water | tropical - fungal infection | white spot | whitespot

Malta - English - Medicines Authority

macarthys laboratories limited bampton road, harold hill, romford essex, rm3 8ug, united kingdom - methylene blue - solution for injection - methylene blue 1 % (w/v) - all other therapeutic products

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

affordable pharmaceuticals, llc - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - polyethylene glycol 3350 420 g in 4 l - peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: - gastrointestinal (gi) obstruction, ileus, or gastric retention - bowel perforation - toxic colitis or toxic megacolon - known allergy or hypersensitivity to any component of peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see how supplied/storage and handling ( 16)] animal reproduction studies have not been conducted with peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. it is also not known whether peg-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive

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)

salix pharmaceuticals, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 100 g in 1 l - moviprep® is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. moviprep is contraindicated in the following conditions: risk summary there are no available data on moviprep in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with moviprep. 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. risk summary there are no data available on the presence of moviprep in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk o