GAVILYTE G TM- polyethylene glycol-3350 and electrolytes powder, for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Lupin Pharmaceuticals,Inc.

INN (Nama Antarabangsa):

POLYETHYLENE GLYCOL 3350

Komposisi:

POLYETHYLENE GLYCOL 3350 236 g in 274.31 g

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

Gavilyte-G (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. Gavilyte-G 4 Liter Disposable Jug                                                                                 NDC 43386-090-19 Storage Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of Gavilyte-G at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

GAVILYTE G TM- POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES POWDER, FOR
SOLUTION
Lupin Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
GaviLyte™-G (GAV-ee-LITE-G)
(PEG-3350 (236 g) and Electrolytes for Oral Solution, USP)
Read this Medication Guide before you start taking GaviLyte-G. 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 GaviLyte-G?
GaviLyte-G 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
GaviLyte-G 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 GaviLyte-G:
•
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 GaviLyte-G?" for
more information about side effects.
What is GaviLyte-G?
GaviLyte-G is a prescription medicine used by adults to clean the
colon before a colonoscopy or barium
enema X-ray examination. GaviLyte-G 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 GaviLyte-G is safe and effective in children.
Who should not take GaviLyte-G?
Do not take GaviLyte-G if your heathcare provider has told you that
you have:
•
a blockage in your bowel (obstruction)
•
an opening in the wall of your stomach or int

Ciri produk

GAVILYTE G TM- POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES POWDER, FOR
SOLUTION
LUPIN PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GAVILYTE™- G SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GAVILYTE™- G.
GAVILYTE™- G (PEG-3350 (236 G) AND ELECTROLYTES FOR ORAL SOLUTION,
USP)
INITIAL U.S. APPROVAL:1984
RECENT MAJOR CHANGES
Warnings and Precautions, Aspiration: (5.7) 05/2021
INDICATIONS AND USAGE
GaviLyte-G 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
Gavilyte-G.
Reconstitute Gavilyte-G with water prior to ingestion.
Do not take oral medications within 1 hour before the start or during
administration of Gavilyte-G. (2.1)
Do not take other laxatives while taking Gavilyte-G.
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 Gavilyte-G.
Adult Dosing Regimen (2.2):
On day prior to colonoscopy, instruct patients to consume a light
breakfast at least 2 hours before
starting Gavilyte-G.
Begin the recommended dosage regimen for Gavilyte-G 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, 2.97 g potassium chloride and 2 g
favoring agent supplied in one 4
liter disposable jug. (3)
CONTRAINDICATION