PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE- polyethylene glycol 3350, sodium chloride, sodium bicarbon

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, chloride ion - UNII:Q32ZN48698), sodium bicarbonate (UNII: 8MDF5V39QO) (sodium cation - UNII:LYR4M0NH37, bicarbonate ion - UNII:HN1ZRA3Q20), potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152, chloride ion - UNII:Q32ZN48698)

Available from:

Affordable Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 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 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see How Supplied/Storage and Handling (16) ] Pregnancy Category C. Animal reproduction studies have not been conducted with PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. It is also not known whether PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. P

Product summary:

In powdered form, for oral administration as a solution following reconstitution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in a disposable jug in powdered form containing: PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with Flavor Packs: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). 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. Each jug has an attached package containing 4 flavor packs (optional); one each 2.0 g: Cherry, Lemon-Lime, Orange and Pineapple flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing. Lemon-Lime Flavor PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. 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. Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with Flavor Packs                NDC 10572-400-01 Lemon-Lime Flavor PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution       NDC 10572-302-01

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE,
POTASSIUM CHLORIDE POWDER, FOR
SOLUTION
Affordable Pharmaceuticals, LLC
----------
Medication Guide
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
for oral solution (PEG-3350, so-
DEE-um klor-IDE, so-DEE-um bi-CAR-bon-ate and po-TASS-ee-um klor-IDE
for oral solution)
Read this Medication Guide before you start taking PEG-3350, sodium
chloride, sodium bicarbonate and
potassium chloride 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,
sodium chloride, sodium
bicarbonate and potassium chloride for oral solution?
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
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 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, sodium chloride, sodium
bicarbonate and potassium chloride 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, sodium chloride, sodium
bicarbonate and potassium chloride
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, sodium
chloride, sodium bicarbonate and
potassium chloride for oral solution” for more information about
side effects.
What is PEG-3350, sodium chloride,

Summary of Product characteristics

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE-
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE,
POTASSIUM CHLORIDE POWDER, FOR
SOLUTION
AFFORDABLE PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEG-3350, SODIUM CHLORIDE, SODIUM
BICARBONATE AND POTASSIUM CHLORIDE FOR ORAL SOLUTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM
CHLORIDE FOR ORAL SOLUTION.
POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND
POTASSIUM CHLORIDE FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions (5) 9/2013
INDICATIONS AND USAGE
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
for oral solution 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
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
for oral solution, 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).
If adding a PEG-3350, sodium chloride, sodium bicarbonate and
potassium chloride for oral solution flavor pack, pour
the contents of flavor powder (i.e., cherry, lemon-lime, orange or
pineapple) into container prior to reconstitution
(2.2).
Early in the evening prior to colonoscopy, fill container containing
PEG-3350, sodium chloride, sodium bicarbonate
and potassium chloride for oral solution powder with lukewarm water to
4 liter fill line (2.2).
After capping container, shake vigorously several times (2.2).
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