GAVILYTE G TM- 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:

Lupin Pharmaceuticals,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:

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, ileus, or gastric retention - Bowel perforation - Toxic colitis or toxic megacolon - Known allergy or hypersensitivity to any component of GaviLyte-G [see How Supplied/Storage and Handling (16) ] Pregnancy Category C. 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 GaviLyte-G did n

Product summary:

In powdered form, for oral administration as a solution following reconstitution. GaviLyte-G is available in a disposable jug in powdered form containing: Disposable Jug :  polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L. Storage: Store in sealed container at 59º to 86°F (15ºC to 30°C).  When reconstituted, keep solution refrigerated. Use within 48 hours, Discard unused portion. Keep out of reach of children. GaviLyte-G     NDC 43386-090-19

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GAVILYTE G TM- POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES POWDER, FOR
SOLUTION
Lupin Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
GaviLyte™-G (GAV-ee-LITE-G)
(PEG-3350 (235 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 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. 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 intestine (bowel
perforation)
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Summary of Product characteristics

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 (5) 9/2013
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
GaviLyte-G, supplied as a powder, must be reconstituted with water
before its use (2.1, 5.8)
On day prior to colonoscopy, instruct patients to:
Eat a light breakfast or have clear liquids (avoid red and purple
liquids) (2.2).
Early in the evening prior to colonoscopy, fill container containing
GaviLyte-G powder with lukewarm water to 4 liter
fill line (2.2)
After capping container, shake vigorously several times. Instruct
patients to consume water or clear liquids during
and after bowel preparation up until 2 hours before time of
colonoscopy (2.3).
ADULTS: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4
liters are consumed or rectal effluent is clear. For
nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour (2.3)
DOSAGE FORMS AND STRENGTHS
For oral solution: polyethylene glycol 3350 236 grams, sodium sulfate
(anhydrous) 22.74 grams, sodium bicarbonate 6.74
grams, sodium chloride 5.86 grams, potassium chloride 2.97 grams and
flavoring ingredients 2 gram; supplied in one 4 liter
disposable jug. (3)
CONTRAINDICATIONS
Gastrointestinal (GI) obstruction, ileus, or gastric retention (4,
5.6)
Bowel perforation (4, 5.6)
Toxic colitis or toxic megacolon (4)
Known allergy or hypersensitivity to components of GaviLyte-G (4, 11)
WARNINGS AND PRECAUTIONS
Risk of fluid and electrolyte abnormalities, arrhythmias,