POLYETHYLENE GLYCOL 3350 powder, for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Nexgen Pharma, Inc.

INN (Rahvusvaheline Nimetus):

POLYETHYLENE GLYCOL 3350

Koostis:

POLYETHYLENE GLYCOL 3350 17 g

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. There have been no reports of accidental overdosage. In the event of overdosage, diarrhea would be the expected major event. If an overdose of drug occurred without concomitant ingestion of fluid, dehydration due to diarrhea may result. Medication should be terminated and free water administered. The oral LD50 is > 50 gm/kg in mice, rats and rabbits.

Toote kokkuvõte:

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 0722-6920-01 Polyethylene Glycol 3350 NF 255g NDC 0722-6921-01 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. STORAGE Store at 20°- 25°C (68°- 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature] Manufactured by: Nexgen Pharma, Inc. Irvine, CA 92614 Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 6920, 6921 Rev 11/08

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

POLYETHYLENE GLYCOL 3350- POLYETHYLENE GLYCOL 3350 POWDER, FOR
SOLUTION
NEXGEN PHARMA, INC.
----------
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(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
inc