País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)
AvKARE, Inc.
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 1 g in 1 g
PRESCRIPTION DRUG
Abbreviated New Drug Application
POLYETHYLENE GLYCOL 3350- POLYETHYLENE GLYCOL 3350 POWDER AVKARE, INC. ---------- POLYETHYLENE GLYCOL 3350, NF POWDER FOR ORAL SOLUTION RX ONLY DESCRIPTION A white powder for reconstitution. Polyethylene Glycol 3350, NF 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(C2H4O)nH 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, NF is an osmotic agent for the treatment of constipation. CLINICAL PHARMACOLOGY PHARMACOLOGY Polyethylene Glycol 3350, NF is an osmotic agent which causes water to be retained with the stool. Essentially, complete recovery of Polyethylene Glycol 3350, NF was shown in normal subjects without constipation. Attempts at recovery of Polyethylene Glycol 3350, NF in constipated patients resulted in incomplete and highly variable recovery. _In vitro_ study showed indirectly that Polyethylene Glycol 3350, NF was not fermented into hydrogen or methane by the colonic microflora in human feces. Polyethylene Glycol 3350, NF 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, NF, 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, NF was statistically superior to placebo during the second week of treatment. In another study, patients with 3 bowel movements or less per week and/or less than 300 grams of stool per week were randomized to 2 dose levels of Polyethylene Glycol 3350, NF or placebo for 10 days each. Success was defined by an increase in both bowel movement frequency and daily sto Leer el documento completo