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

lupin pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 420 g in 438.4 g - gavilyte-n is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. gavilyte-n 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 gavilyte-n for oral solution [see how supplied/storage and handling (16)] animal reproduction studies have not been conducted with gavilyte-n. it is also not known whether gavilyte-n can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. gavilyte-n should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when gavilyte-n is administered to a nursing woman. safety and effectiveness of gavilyte-n in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of gavilyte-n in adults with additional safety and efficacy data from published studies of similar formulations. use of gavilyte-n in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. dehydration has been reported in one child and hypokalemia has been reported in 3 children. clinical studies of gavilyte-n 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.

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

lupin pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium cation - unii:lyr4m0nh37), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 236 g in 274.31 g - gavilyte-g is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. gavilyte-g is contraindicated in the following conditions: - gastrointestinal (gi) obstruction [see warnings and precautions (5.6)] - bowel perforation [see warnings and precautions (5.6)] - toxic colitis or toxic megacolon - gastric retention - ileus - hypersensitivity to any component of gavilyte-g [see warnings and precautions (5.8)] animal reproduction studies have not been conducted with gavilyte-g. it is also not known whether gavilyte-g can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. gavilyte-g should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when gavilyte-g is administered to a nursing woman. safety and effectiveness of gavilyte-g in pediatric patients have not been established. clinical studies of

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

affordable pharmaceuticals, llc - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium cation - unii:lyr4m0nh37, sulfate ion - unii:7is9n8kpmg), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q3 - polyethylene glycol 3350 236 g in 4 l - peg-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. peg-3350 and electrolytes for oral solution is contraindicated in the following conditions: - gastrointestinal (gi) obstruction [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precautions ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - ileus - hypersensitivity to any component of peg-3350 and electrolytes for oral solution [see warnings and precautions ( 5.8)] animal reproduction studies have not been conducted with peg-3350 and electrolytes for oral solution. it is also not known whether peg-3350 and electrolytes for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. peg-3350 and electrolytes for oral solution should be given to a pregnant woman only if clearly nee

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

braintree laboratories, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium cation - unii:lyr4m0nh37, sulfate ion - unii:7is9n8kpmg), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q3 - polyethylene glycol 3350 236 g in 4 l - golytely is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. golytely is contraindicated in the following conditions: - gastrointestinal (gi) obstruction [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precautions ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - ileus - hypersensitivity to any component of golytely [see warnings and precautions ( 5.8)] animal reproduction studies have not been conducted with golytely. it is also not known whether golytely can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. golytely should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when golytely is administered to a nursing woman. safety and effectiv

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

braintree laboratories, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - polyethylene glycol 3350 420 g in 4 l - nulytely is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. nulytely 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 nulytely [ see how supplied/storage and handling ( 16) ] pregnancy category c. animal reproduction studies have not been conducted with nulytely. it is also not known whether nulytely can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. nulytely should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when nulytely is administered to a nursing woman. safety and effectiveness of nulyte

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

lupin pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium sulfate anhydrous - unii:36kcs0r750), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 236 g in 274.31 g - gavilyte-g is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults. gavilyte-g 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 gavilyte-g [see how supplied/storage and handling (16) ] pregnancy category c. animal reproduction studies have not been conducted with gavilyte-g. it is also not known whether gavilyte-g can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. gavilyte-g should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when gavilyte-g is administered to a nursing woman. safety and effectiveness of gavilyte-g in pediatric patients have not been established. clinical studies of gavilyte-g did n

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

wallace pharmaceuticals inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - polyethylene glycol 3350 420 g in 4 l - trilyte is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. trilyte is contraindicated in the following conditions: animal reproduction studies have not been conducted with trilyte. it is also not known whether trilyte can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. trilyte should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when trilyte is administered to a nursing woman. safety and effectiveness of trilyte in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of trilyte in adults with additional safety and efficacy data from published studies of similar formulations. use of trilyte in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as

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)

nexgen pharma, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - for the treatment of occasional constipation. this product should be used for 2 weeks or less or as directed by a physician. polyethylene glycol 3350 nf is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol. there have been no reports of accidental overdosage. in the event of overdosage, diarrhea would be the expected major event. if an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. medication should be terminated and free water administered. the oral ld50 is > 50 gm/kg in mice, rats and rabbits.

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

nucare pharmaceuticals,inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - for the treatment of occasional constipation. this product should be used for 2 weeks or less or as directed by a physician. polyethylene glycol 3350 nf is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.