TRILYTE WITH FLAVOR PACKS- polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride powder, for sol

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wallace Pharmaceuticals Inc.

INN (International Name):

POLYETHYLENE GLYCOL 3350

Composition:

POLYETHYLENE GLYCOL 3350 420 g in 4 L

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TRILYTE is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. TRILYTE is contraindicated in the following conditions: Animal reproduction studies have not been conducted with TRILYTE. It is also not known whether TRILYTE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TRILYTE 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 TRILYTE is administered to a nursing woman. Safety and effectiveness of TRILYTE in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of TRILYTE in adults with additional safety and efficacy data from published studies of similar formulations. Use of TRILYTE in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as

Product summary:

In powdered form, for oral administration as a solution following reconstitution. TRILYTE with flavor packs (PEG 3500, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is supplied in a 4 liter bottle with an attached package containing flavor packs. This preparation is supplied in powdered form (white to off-white powder) for oral administration as a solution following reconstitution. Each 4 liter bottle contains polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. Each flavor pack contains 3.22 g of flavoring ingredients. When made up to 4 liters volume with water, the solution contains PEG 3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. TRILYTE with flavor packs     4 liter     NDC 51525-6831-4 Storage: Store in sealed container at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRILYTE WITH FLAVOR PACKS- POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE,
SODIUM
BICARBONATE AND POTASSIUM CHLORIDE POWDER, FOR SOLUTION
Wallace Pharmaceuticals Inc.
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MEDICATION GUIDE
TRILYTE
(traI-laIt)
(PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride
oral solution)
Read this Medication Guide before you start taking TRILYTE. 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 TRILYTE?
TRILYTE 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
TRILYTE 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 TRILYTE:
•
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 TRILYTE” for
more information about side effects.
What is TRILYTE?
TRILYTE is a prescription medicine used by adults to clean the colon
before a colonoscopy. TRILYTE
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.
TRILYTE is safe and effective for use in pediatric patients aged 6
months and older.
Who should not take TRILYTE?
Do not take TRILYTE 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 i

Summary of Product characteristics

TRILYTE WITH FLAVOR PACKS- POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE,
SODIUM
BICARBONATE AND POTASSIUM CHLORIDE POWDER, FOR SOLUTION
WALLACE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRILYTE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRILYTE.
TRILYTE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE
AND POTASSIUM CHLORIDE FOR ORAL
SOLUTION) WITH FLAVOR PACKS
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
TRILYTE is a combination of PEG 3350, an osmotic laxative, and
electrolytes indicated for cleansing of the colon in
preparation for colonoscopy in adults and pediatric patients aged 6
months or greater (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
For oral solution: polyethylene glycol 3350 420 grams, sodium
bicarbonate 5.72 grams, sodium chloride 11.2 grams,
potassium chloride 1.48 grams, and flavoring ingredients 3.22 grams;
supplied in one 4 liter disposable jug (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥ 3%) are: nausea, abdominal fullness
and bloating. Abdominal cramps, vomiting and
anal irritation occur less frequently (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WALLACE PHARMACEUTICALS
INC. AT 1-888-444-1527 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
TRILYTE, supplied as a powder, must be reconstituted with water before
its use (2.1, 5.8)
On day prior to colonoscopy, instruct patients to:
•
•
•
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Eat a light breakfast or have clear liquids (avoid red and purple
liquids) (2.2).
If adding a TRILYTE flavor pack, pour the contents of flavor powder
(i.e., cherry or lemon-lime) into container
prior to reconstitution (2.2).
Early in the evening prior to colonoscopy, fill container containing
TRILYTE powder with lukewarm water to 4
liter fill line (2.2).
After capping container, shake vigorously several times (2.2).
Instruct patients to consume w