PEG-3350, ELECTROLYTES, AND ASCORBATE- polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium asc

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 (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Available from:

Oceanside Pharmaceuticals

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is contraindicated in the following conditions: Risk Summary There are no available data on Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary The

Product summary:

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is supplied as a white to yellow powder for reconstitution and is lemon flavored. NDC 68682-201-75, Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution, single-use outer carton: Storage

Authorization status:

New Drug Application

Patient Information leaflet

CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE, AND ASCORBIC ACID
Oceanside Pharmaceuticals
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MEDICATION GUIDE
MEDICATION GUIDE
POLYETHYLENE GLYCOL-3350, ELECTROLYTES, AND ASCORBATE FOR ORAL
SOLUTION
(polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium
chloride, sodium ascorbate, and
ascorbic acid for oral solution)
Read this Medication Guide and Instructions for Use before your
colonoscopy and again before you start
taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral
Solution.
What is the most important information I should know about
Polyethylene Glycol-3350, Electrolytes,
and Ascorbate for Oral Solution?
Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral
Solution and other 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:
o
abnormal heartbeats that can cause death.
o
seizures. This can happen even if you have never had a seizure.
o
kidney problems.
Your chance of having fluid loss and changes in body salts with
Polyethylene Glycol-3350, Electrolytes,
and Ascorbate for Oral Solution is higher if you:
•
have heart problems.
•
have kidney problems.
•
take water pills (diuretics), high blood pressure medicine, or
non-steroidal anti-inflammatory drugs
(NSAIDs).
Tell your healthcare provider right away if you have any of these
symptoms of serious loss of body fluid
(dehydration) while taking Polyethylene Glycol-3350, Electrolytes, and
Ascorbate for Oral Solution:
•
vomiting
•
urinating less often than normal
•
dizziness
•
headache
See “What are the possible side effects of Polyethylene Glycol-3350,
Electrolytes, and Ascorbate for
Oral Solution?” for more information about side effects.
What is Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral
Solution?
Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral
Solution is a prescription medicine used
by adults to clean the colon before a co

Summary of Product characteristics

PEG-3350, ELECTROLYTES, AND ASCORBATE- POLYETHYLENE GLYCOL 3350,
SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE,
AND
ASCORBIC ACID
OCEANSIDE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POLYETHYLENE GLYCOL-
3350, ELECTROLYTES, AND ASCORBATE FOR ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR POLYETHYLENE GLYCOL-3350, ELECTROLYTES,
AND ASCORBATE
FOR ORAL SOLUTION.
POLYETHYLENE GLYCOL-3350, ELECTROLYTES, AND ASCORBATE FOR ORAL
SOLUTION
(POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM
CHLORIDE, SODIUM
ASCORBATE, AND ASCORBIC ACID FOR ORAL SOLUTION)
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral
Solution is an osmotic laxative indicated for
cleansing of the colon as a preparation for colonoscopy in adults. (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration:
•
•
•
•
•
Dosing Regimen:
•
•
•
DOSAGE FORMS AND STRENGTHS
For Oral Solution: 2 pouches labeled Pouch A and 2 pouches labeled
Pouch B. (3)
•
•
CONTRAINDICATIONS
•
•
•
•
•
•
Two doses of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for
Oral Solution are required for a
complete preparation for colonoscopy, using a “Two-Day” preferred
method or “One-Day” alternative
method dosing regimen. (2.1)
Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral
Solution must be reconstituted in water
prior to ingestion. (2.1)
Additional clear liquids must be consumed after each dose of
Polyethylene Glycol-3350, Electrolytes,
and Ascorbate for Oral Solution in both dosing regimens. (2.1, 5.1)
Do not take other laxatives while taking Polyethylene Glycol-3350,
Electrolytes, and Ascorbate for Oral
Solution. (2.1, 5.5)
Do not take oral medications within 1 hour of starting each dose.
(2.1)
_Two-Day (Split-Dose) (Preferred Method): _Dose 1 the evening before
the colonoscopy, and Dose 2
the morning of