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:

Paddock Laboratories, 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, USP Powder for Oral Solution 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, 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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