POLYETHYLENE GLYCOL 3350 powder

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:

Lannett Company, Inc..

INN (International Name):

POLYETHYLENE GLYCOL 3350

Composition:

POLYETHYLENE GLYCOL 3350 1 g in 1 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 Powder for Oral Solution is available in two package sizes: a 16 oz. container of 255 grams of laxative powder (NDC 62175-442-15) and a 24 oz. container of 527 grams of laxative powder (NDC 62175-442-31). The dosing cap 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). Store at 20° - 25°C (68° - 77°F); excursions permitted between 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
LANNETT COMPANY, 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