POLYETHYLENE GLYCOL 3350 powder for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Polyethylene Glycol 3350 (UNII: G2M7P15E5P) (Polyethylene Glycol 3350 - UNII:G2M7P15E5P)

Disponível em:

Golden State Medical Supply, Inc.

DCI (Denominação Comum Internacional):

Polyethylene Glycol 3350

Composição:

Polyethylene Glycol 3350 17 g in 17 g

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

POLYETHYLENE GLYCOL 3350- POLYETHYLENE GLYCOL 3350 POWDER, FOR
SOLUTION
GOLDEN STATE MEDICAL SUPPLY, INC.
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POLYETHYLENE GLYCOL 3350 NF
POLYETHYLENE GLYCOL 3350 POWDER FOR
ORAL SOLUTION
DESCRIPTION
A white powder for reconstitution. Polyethylene Glycol 3350 NF
(Polyethylene Glycol 3350 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 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 defi