国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P)
Alaven Pharmaceutical LLC
Polyethylene Glycol 3350
Polyethylene Glycol 3350 420 g in 4 L
PRESCRIPTION DRUG
Abbreviated New Drug Application
TRILYTE WITH FLAVOR PACKS- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE POWDER, FOR SOLUTION ALAVEN PHARMACEUTICAL LLC ---------- TRILYTE WITH FLAVOR PACKS (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) RX ONLY DESCRIPTION TRILYTE is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride. Flavor packs, each containing 3.22 g of flavoring ingredients, are attached to the 4 liter bottle. See individual flavor packs for complete listing of ingredients. When dissolved in water to a volume of 4 liters, TRILYTE with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. One flavor pack can be added before reconstitution to flavor the solution. TRILYTE with flavor packs is administered orally or via nasogastric tube as a gastrointestinal lavage. This preparation can be used without the addition of a flavor pack. CLINICAL PHARMACOLOGY TRILYTE with flavor packs induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance. INDICATIONS AND USAGE TRILYTE with flavor packs is indicated for bowel cleansing prior to colonoscopy. CONTRAINDICATIONS TRILYTE with flavor packs is contraindicated in patients known to be hypersensitive to any of the components. TRILYTE with flavor packs is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon. WARNINGS The flavor packs are for use with the accompanying 4 liter bottle. No additional ingredients, e.g., flavorings, sh 完全なドキュメントを読む