POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED powder, for solution POLYETHY

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, CHLORIDE ION - UNII:Q32ZN48698), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Available from:

Strides Pharma Science Limited

INN (International Name):

POLYETHYLENE GLYCOL 3350

Composition:

POLYETHYLENE GLYCOL 3350 420 g in 4 L

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: - Gastrointestinal (GI) obstruction, ileus, or gastric retention - Bowel perforation - Toxic colitis or toxic megacolon - Known allergy or hypersensitivity to any component of polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see How Supplied/Storage and Handling (16)] Animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. It is also not known whether polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered t

Product summary:

In powdered form, for oral administration as a solution following reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in a disposable jug in powdered form containing: Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with Flavor Packs : polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients acesulfame potassium 0.1 gram and flavor lemon 0.4 grams for lemon flavor and acesulfame potassium 0.1 gram and flavor orange 0.6 grams for orange flavor. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Storage: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in following flavors:

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND
POTASSIUM CHLORIDE - UNFLAVORED - POLYETHYLENE GLYCOL 3350, SODIUM
CHLORIDE, SODIUM
BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED POWDER, FOR SOLUTION
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND
POTASSIUM CHLORIDE WITH LEMON FLAVOR - POLYETHYLENE GLYCOL 3350,
SODIUM CHLORIDE,
SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH LEMON FLAVOR POWDER,
FOR SOLUTION
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND
POTASSIUM CHLORIDE WITH ORANGE FLAVOR - POLYETHYLENE GLYCOL 3350,
SODIUM CHLORIDE,
SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH ORANGE FLAVOR POWDER,
FOR SOLUTION
Strides Pharma Science Limited
----------
MEDICATION GUIDE
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and
Potassium Chloride for Oral Solution
(pol" ee eth' i leen glye' kol 3350, soe' dee um klor' ide, soe' dee
um bye kar' bo nate and poe tas' ee um klor'
ide)
Read this Medication Guide before you start taking polyethylene glycol
3350, sodium chloride, sodium
bicarbonate and potassium chloride for oral solution. This information
does not take the place of talking with
your healthcare provider about your medical condition or your
treatment.
What is the most important information I should know about
polyethylene glycol 3350, sodium chloride,
sodium bicarbonate and potassium chloride for oral solution?
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and
potassium chloride for oral solution and
other osmotic bowel preparations can cause serious side effects,
including:
Serious loss of body fluid (dehydration) and changes in blood salts
(electrolytes) in your blood.
These changes can cause:
•
abnormal heartbeats that can cause death
•
seizures . This can happen even if you have never had a seizure.
•
kidney problems
Your chance of having fluid loss and changes in body salts with
polyethylene glycol 3350, sodium chloride,
sodium bicarbonate and potassium chloride for oral solution is higher
if you:
•
have heart

Summary of Product characteristics

POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE
AND POTASSIUM CHLORIDE - UNFLAVORED - POLYETHYLENE GLYCOL 3350,
SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE -
UNFLAVORED POWDER, FOR SOLUTION
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE
AND POTASSIUM CHLORIDE WITH LEMON FLAVOR - POLYETHYLENE GLYCOL 3350,
SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH LEMON
FLAVOR POWDER, FOR SOLUTION
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE
AND POTASSIUM CHLORIDE WITH ORANGE FLAVOR - POLYETHYLENE GLYCOL
3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH
ORANGE FLAVOR POWDER, FOR SOLUTION
STRIDES PHARMA SCIENCE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POLYETHYLENE GLYCOL
3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE FOR
ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
POLYETHYLENE GLYCOL
3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE FOR
ORAL
SOLUTION.
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND
POTASSIUM
CHLORIDE FOR ORAL SOLUTION (UNFLAVORED, LEMON AND ORANGE FLAVORS)
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and
potassium chloride for oral solution is
a combination of PEG 3350, an osmotic laxative, and electrolytes
indicated for cleansing of the colon in
preparation for colonoscopy in adults and pediatric patients aged 6
months or greater (1)
DOSAGE AND ADMINISTRATION
Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and
potassium chloride for oral solution,
supplied as a powder, must be reconstituted with water before its use
(2.1, 5.8)
On day prior to colonoscopy, instruct patients to:
Eat a light breakfast or have clear liquids (avoid red and purple
liquids) (2.2).
Early in the evening prior to colonoscopy, fill container containing
polyethylene glycol 3350, sodium
chloride, sodium