GOLYTELY- polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride powder, fo

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Braintree Laboratories, Inc.

INN（国際名）:

Polyethylene Glycol 3350

構図:

Polyethylene Glycol 3350 236 g in 4 L

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY 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 GoLYTELY [see Warnings and Precautions ( 5.8)] Animal reproduction studies have not been conducted with GoLYTELY. It is also not known whether GoLYTELY can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GoLYTELY 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 GoLYTELY is administered to a nursing woman. Safety and effectiv

製品概要:

GoLYTELY (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 powder. GoLYTELY 4 Liter Disposable Jug          NDC 52268-100-01 Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of GoLYTELY at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration ( 2.1)] .

認証ステータス:

New Drug Application

情報リーフレット

potassium chloride powder, for solution
Braintree Laboratories, Inc.
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Medication Guide
GoLYTELY® (Go-lite-ly)
(PEG-3350 and Electrolytes)
for oral solution
Read this Medication Guide before you start taking GoLYTELY. 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 GoLYTELY?
GoLYTELY 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
GoLYTELY 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 GoLYTELY:
•
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 GoLYTELY” for
more information about side effects.
What is GoLYTELY?
GoLYTELY is a prescription medicine used by adults to clean the colon
before a colonoscopy or barium
enema X-ray examination. GoLYTELY 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
colonoscopy. It is not known if GoLYTELY is safe and effective in
children.
Who should not take GoLYTELY?
Do not take GoLYTELY if your healthcare provider has told you that you
have:
•
a blockage in your bowel (obstruction).
•
an opening in the wall of your stomach or intestine (bowel
perforation).
•
a very dilated intestine (toxic m

製品の特徴

GOLYTELY- POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM
BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE POWDER, FOR SOLUTION
BRAINTREE LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GOLYTELY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GOLYTELY.
GOLYTELY (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
GoLYTELY 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
GoLYTELY.
Reconstitute GoLYTELY with water prior to ingestion.
Do not take oral medications within 1 hour before the start or during
administration of GoLYTELY. ( 2.1)
Do not take other laxatives while taking GoLYTELY.
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 GoLYTELY.
Adult Dosing Regimen ( 2.2):
On day prior to colonoscopy, instruct patients to consume a light
breakfast at least 2 hours before
starting GoLYTELY.
Begin the recommended dosage regimen for GoLYTELY 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 administration,
see the full prescribing
information. ( 2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
For Oral Solution: 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 per
4 liters. (3)
CONTRAINDICATIONS
Gastro