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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 16.1 g - prepopik® is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. prepopik is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium [see warnings and precautions (5.4)] - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)] - bowel perforation [see warnings and precautions (5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in prepopik [see adverse reactions (6.2)] risk summary there are no data with prepopik use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in an animal reproduction study, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 160 ml - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)]. - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)]. - bowel perforation [see warnings and precautions (5.6)]. - toxic colitis or toxic megacolon. - gastric retention. - hypersensitivity to any of the ingredients in clenpiq [see adverse reactions (6.2)]. risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based

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

camber pharmaceuticals, inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is contraindicated in the following conditions: • patients with severe renal impairment (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium  [see warnings and precautions ( 5.4)] • gastrointestinal obstruction or ileus [see warnings and precautions ( 5.6)] • bowel perforation [see warnings and precautions ( 5.6)] • toxic colitis or toxic megacolon • gastric retention • hypersensitivity to any of the ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution  [see advers

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)

strides pharma science limited - 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 - polyethylene glycol 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. polyethylene glycol 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 polyethylene glycol 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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. it is also not known whether polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered t

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) - 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) ] pregnancy category c. 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 capacity. p

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - sodium picosulfate, quantity: 7.5 mg/ml - oral liquid - excipient ingredients: citric acid monohydrate; sodium benzoate; purified water; sodium citrate dihydrate; sorbitol solution (70 per cent) (non-crystallising) - for the treatment of constipation

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

asm aerosol-service ag - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)] - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)] - bowel perforation [see warnings and precautions (5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in clenpiq risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based on body surface area during organogenesis. the estimated background risk of major

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)]. - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)]. - bowel perforation [see warnings and precautions (5.6)]. - toxic colitis or toxic megacolon. - gastric retention. - hypersensitivity to any of the ingredients in clenpiq [see adverse reactions (6.2)]. risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based

Ireland - English - HPRA (Health Products Regulatory Authority)

ferring ireland ltd - sodium picosulfate - tablets - 5 milligram