POLYETHYLENE GLYCOL 3350- polyethylene glycol 3350 powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

Polyethylene Glycol 3350

Composition:

Polyethylene Glycol 3350 17 g in 17 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 NF is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

Product summary:

In powdered form, for oral administration after dissolution in water, juice, soda, coffee, or tea. Polyethylene Glycol 3350 NF (Polyethylene Glycol 3350 Powder for Oral Solution) is available in two package sizes: a 500 cc container of 255 grams of laxative powder and a 950 cc container of 527 grams of laxative powder. NDC 51991-457-58 Polyethylene Glycol 3350 NF 255g NDC 51991-457-57 Polyethylene Glycol 3350 NF 527g The dosing cup supplied with each bottle is marked with a measuring line and may be used to measure a single Polyethylene Glycol 3350 NF dose of 17 grams (about 1 heaping tablespoonful). Rx only Keep this and all medications out of the reach of children. Store at 20°- 25°C (68°- 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POLYETHYLENE GLYCOL 3350- POLYETHYLENE GLYCOL 3350 POWDER, FOR
SOLUTION
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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 fo