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

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SODIUM CATION - UNII:LYR4M0NH37, SULFATE ION - UNII:7IS9N8KPMG), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q3

Հասանելի է:

A-S Medication Solutions

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 [see Warnings and Precautions ( 5.6)] - Bowel perforation [see Warnings and Precautions ( 5.6)] - Toxic colitis or toxic megacolon - Gastric retention - Ileus - Hypersensitivity to any component of PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions ( 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 nee

Ապրանքի ամփոփագիր:

Product: 50090-6521 NDC: 50090-6521-0 4 L in a JUG

Լիազորման կարգավիճակը:

New Drug Application Authorized Generic

Տեղեկատվական թերթիկ

SODIUM CHLORIDE, POTASSIUM CHLORIDE POWDER, FOR SOLUTION
A-S Medication Solutions
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Medication Guide
PEG-3350 and Electrolytes for Oral Solution
(PEG-3350 and i-lek-truh-lahyts 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

Ապրանքի հատկությունները

PEG-3350 AND ELECTROLYTES- POLYETHYLENE GLYCOL 3350, SODIUM SULFATE
ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE
POWDER,
FOR SOLUTION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEG-3350 AND
ELECTROLYTES FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
PEG-3350 AND ELECTROLYTES FOR ORAL SOLUTION.
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
Warnings and Precautions, Aspiration: ( 5.7)
05/2021
INDICATIONS AND USAGE
PEG-3350 and Electrolytes for Oral Solution 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):
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):
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.
F