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출처: NLM (National Library of Medicine)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)
Paddock Laboratories, LLC
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 17 g in 17 g
ORAL
PRESCRIPTION DRUG
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, USP Powder for Oral Solution is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.
In powdered form, for oral administration after dissolution in water, juice, soda, coffee, or tea. Polyethylene Glycol 3350, USP Powder for Oral Solution is available in three package sizes; a 16 oz. container of 255 grams of laxative powder (NDC 0574-0412 -02), a 32 oz. container of 527 grams of laxative powder (NDC 0574-0412 -05), and a box of 14 sachets, each sachet containing 17 grams of laxative powder (NDC 0574-0412 -07). The dosing cup with each bottle is marked with a measuring line and may be used to measure a single Polyethylene Glycol 3350, USP Powder for Oral Solution dose of 17 grams (about 1 heaping tablespoon).
Abbreviated New Drug Application
POLYETHYLENE GLYCOL 3350- POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION PADDOCK LABORATORIES, LLC ---------- POLYETHYLENE GLYCOL 3350, USP POWDER FOR ORAL SOLUTION RX ONLY DESCRIPTION A white powder for reconstitution. Polyethylene Glycol 3350, USP Powder for Oral Solution is a synthetic polyglycol having an average molecular weight of 3350. The actual molecular weight is not less than 90.0 percent and not greater than 110.0 percent of the nominal value. The chemical formula is HO(C H O) H in which n represents the average number of oxyethylene groups. Below 55°C it is a free flowing white powder freely soluble in water. Polyethylene Glycol 3350, USP Powder for Oral Solution is an osmotic agent for the treatment of constipation. CLINICAL PHARMACOLOGY PHARMACOLOGY: Polyethylene Glycol 3350, USP Powder for Oral Solution is an osmotic agent which causes water to be retained with the stool. Essentially, complete recovery of Polyethylene Glycol 3350, USP Powder for Oral Solution was shown in normal subjects without constipation. Attempts at recovery of Polyethylene Glycol 3350, USP Powder for Oral Solution in constipated patients resulted in incomplete and highly variable recovery. In vitro study showed indirectly that Polyethylene Glycol 3350, USP Powder for Oral Solution was not fermented into hydrogen or methane by the colonic microflora in human feces. Polyethylene Glycol 3350, USP Powder for Oral Solution appears to have no effect on the active absorption or secretion of glucose or electrolytes. There is no evidence of tachyphylaxis. CLINICAL TRIALS In one study, patients with less than 3 bowel movements per week were randomized to Polyethylene Glycol 3350, USP Powder for Oral Solution, 17 grams, or placebo for 14 days. An increase in bowel movement frequency was observed for both treatment groups during the first week of treatment. Polyethylene Glycol 3350, USP Powder for Oral Solution was statistically superior to placebo during the second week of treatment. In another study, patients with 3 bowel movements or 전체 문서 읽기