PEG-3350 AND ELECTROLYTES- polyethylene glycol 3350, sodium chloride, potassium chloride, sodium bicarbonate, and sodium sulfate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Lannett Company, Inc.

INN (International Name):

POLYETHYLENE GLYCOL 3350

Composition:

POLYETHYLENE GLYCOL 3350 240 g in 4 L

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PEG-3350 & ELECTROLYTES is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. PEG-3350 & ELECTROLYTES is contraindicated in patients known to be hypersensitive to any of the components. PEG-3350 & ELECTROLYTES is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

Product summary:

PEG-3350 & ELECTROLYTES is supplied in 4 liter bottles. Each 4 liter bottle contains polyethylene glycol 3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. The preparation is supplied in powdered form for oral administration as a solution. PEG-3350 & ELECTROLYTES 4 liter NDC 62175-446-01 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION. Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA L2152J Rev. 3E 01/2011

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PEG-3350 AND ELECTROLYTES- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE,
POTASSIUM
CHLORIDE, SODIUM BICARBONATE, AND SODIUM SULFATE POWDER, FOR SOLUTION
LANNETT COMPANY, INC.
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PEG-3350 & ELECTROLYTES FOR ORAL SOLUTION
RX ONLY
DESCRIPTION:
PEG-3350 & ELECTROLYTES is a colon lavage preparation provided as
water-soluble components
for solution. In solution each PEG-3350 & ELECTROLYTES preparation
delivers the following, in
grams per liter.
Polyethylene glycol 3350 60.00
Sodium chloride
1.46
Potassium chloride
0.745
Sodium bicarbonate
1.68
Sodium sulfate
5.68
When dissolved in sufficient water to make 4 liters, the final
solution contains
125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L
sulfate,
35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The
reconstituted solution is isosmotic and
has a mildly salty taste. PEG-3350 & ELECTROLYTES is administered
orally or via nasogastric tube.
CLINICAL PHARMACOLOGY:
PEG-3350 & ELECTROLYTES cleanses the bowel by induction of diarrhea.
The osmotic activity of
polyethylene glycol 3350, in combination with the electrolyte
concentration, results in virtually no net
absorption or excretion of ions or water. Accordingly, large volumes
may be administered without
significant changes in fluid and electrolyte balance.
INDICATIONS AND USAGE:
PEG-3350 & ELECTROLYTES is indicated for bowel cleansing prior to
colonoscopy or barium
enema X-ray examination.
CONTRAINDICATIONS:
PEG-3350 & ELECTROLYTES is contraindicated in patients known to be
hypersensitive to any of the
components. PEG-3350 & ELECTROLYTES is contraindicated in patients
with ileus, gastrointestinal
obstruction, gastric retention, bowel perforation, toxic colitis or
toxic megacolon.
WARNINGS:
No additional ingredients (e.g., flavorings) should be added to the
solution. PEG-3350 &
ELECTROLYTES should be used with caution in patients with severe
ulcerative colitis.
PRECAUTIONS:
GENERAL:
Patients with impaired gag reflex, unconscious or semiconscious
patients and patients prone to
regurgitation or