POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES 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), SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Available from:

Novel Laboratories, Inc.

INN (International Name):

POLYETHYLENE GLYCOL 3350

Composition:

POLYETHYLENE GLYCOL 3350 236 g in 274.31 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PEG-3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. PEG-3350 and electrolytes for oral solution is contraindicated in the following conditions: - Gastrointestinal (GI) obstruction (5.6) - Bowel perforation (5.6) - Toxic colitis or toxic megacolon - Gastric retention - Ileus - Hypersensitivity to components of PEG-3350 and electrolytes for oral solution (5.8) Animal reproduction studies have not been conducted with PEG-3350 and electrolytes for oral solution. It is also not known whether PEG-3350 and electrolytes for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350 and electrolytes for oral solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PEG-3350 and electrolytes for oral solution is administ

Product summary:

Polyethylene glycol 3350 and electrolytes for oral solution is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white to off white powder. $$UnOrderedlist • When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride. $$EndUnOrderedlist Polyethylene glycol 3350 and electrolytes for oral solution 4 Liter Disposable Jug                                 NDC 40032-090-19 Storage: Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of PEG-3350 and electrolytes for oral solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES - POLYETHYLENE GLYCOL-3350
AND
ELECTROLYTES POWDER, FOR SOLUTION
Novel Laboratories, Inc.
----------
MEDICATION GUIDE
PEG-3350 and Electrolytes for Oral Solution
Read this Medication Guide before you start taking PEG-3350 and
electrolytes 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 PEG-3350
and electrolytes for oral solution?
PEG-3350 and electrolytes 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 (arrhythmias) 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
PEG-3350 and electrolytes for oral solution
is higher if you:
•
have heart problems
•
have kidney problems
•
take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)
Tell your healthcare provider right away if you have any of these
symptoms of a loss of too much body fluid
(dehydration) while taking PEG-3350 and electrolytes for oral
solution:
•
vomiting that prevents you from keeping down the solution
•
dizziness
•
urinating less often than normal
•
headache
See Section "what are the possible side effects of peg-3350 and
electrolytes for oral solution" for more
information about side effects.
What is PEG-3350 and electrolytes for oral solution?
PEG-3350 and electrolytes for oral solution is a prescription medicine
used by adults to clean the colon
before a colonoscopy or barium enema X-ray examination. PEG-3350 and
electrolytes for oral solution
cleans your colon by causing you to have diarrhea (loose stools).
Cleaning your colon helps your healthcare
provider see the inside of your colon more clearly during your
col

Summary of Product characteristics

POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES - POLYETHYLENE GLYCOL-3350
AND ELECTROLYTES POWDER, FOR SOLUTION
NOVEL LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEG-3350 AND ELECTROLYTE
FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PEG-3350 AND
ELECTROLYTE FOR ORAL SOLUTION.
PEG-3350 (236 G) AND ELECTROLYTE FOR ORAL SOLUTION, USP
INITIAL U.S. APPROVAL:1984
RECENT MAJOR CHANGES
Warnings and Precautions, Aspiration (5.7) 5/2021
INDICATIONS AND USAGE
PEG-3350 and electrolytes for oral solution, USP is a combination of
PEG 3350, an osmotic laxative, and
electrolytes indicated for cleansing of the colon in preparation for
colonoscopy and barium enema X-ray
examination in adults (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration (2.1): (2)
Correct fluid and electrolyte abnormalities before treatment with
PEG-3350 and electrolytes for oral
solution.
Reconstitute PEG-3350 and electrolytes for oral solution with water
prior to ingestion.
Do not take oral medications within 1 hour before the start or during
administration of PEG-3350 and
electrolytes for oral solution. (2.1)
Do not take other laxatives while taking PEG-3350 and electrolytes for
oral solution.
Consume only clear liquids; avoid red and purple liquids.
Consume water or other clear liquids up until 2 hours before the time
of the colonoscopy.
Do not consume solid food within 2 hours before starting PEG-3350 and
electrolytes for oral solution.
Adult Dosing Regimen (2.2): (2)
On day prior to colonoscopy, instruct patients to consume a light
breakfast at least 2 hours before
starting PEG-3350 and electrolytes for oral solution.
Begin the recommended dosage regimen for PEG-3350 and electrolytes for
oral solution early in the
evening on the day before colonoscopy
Drink reconstituted solution at a rate of 8 ounces every 10 minutes,
until 4 liters are consumed, or
rectal effluent is clear.
For complete information on dosing, preparation and