POLYETHYLENE GLYCOL 3350 powder for solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)

Доступно од:

REMEDYREPACK INC.

INN (Међународно име):

POLYETHYLENE GLYCOL 3350

Састав:

POLYETHYLENE GLYCOL 3350 17 g

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

POLYETHYLENE GLYCOL 3350 - POLYETHYLENE GLYCOL 3350 POWDER, FOR
SOLUTION
REMEDYREPACK INC.
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POLYETHYLENE GLYCOL 3350, NFPOWDER FOR ORAL SOLUTION
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(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, NF Powder for Oral
Solution is an osmotic agent for the treatment of constipation.
CLINICAL PHARMACOLOGY
Polyethylene Glycol 3350, NF Powder for Oral Solution is an osmotic
agent which causes water to be
retained with the stool.
Essentially, complete recovery of Polyethylene Glycol 3350, NF Powder
for Oral Solution was shown
in normal subjects without constipation. Attempts at recovery of
Polyethylene Glycol 3350, NF Powder
for Oral Solution in constipated patients resulted in incomplete and
highly variable recovery. In vitro
study showed indirectly that Polyethylene Glycol 3350, NF Powder for
Oral Solution was not
fermented into hydrogen or methane by the colonic microflora in human
feces. Polyethylene Glycol
3350, NF 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 STUDIES
In one study, patients with less than 3 bowel movements per week were
randomized to Polyethylene
Glycol 3350, NF 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, NF Powder for Oral Solution 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 gra