POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED powder, for solution POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMO

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, BICARBONATE ION - UNII:HN1ZRA3Q20), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORATE (UNII: H35KS68EE7) (POTASSIUM CATION - UNII:295O53K152, CHLORATE ION - UNII:08Z8093742)

Available from:

Strides Pharma Science Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Polyethylene Glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults Polyethylene Glycol 3350 and electrolytes for oral solution, 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 Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.8)] Animal reproduction studies have not been conducted with Polyethylene Glycol 3350 and electrolytes for oral solution. It is also not known whether Polyethylene Glycol 3350 and electrolytes for oral solution, can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Polyethylene Glycol 3350 and electrolytes for oral solution, should be given to a pregnant woman only if clearl

Product summary:

Polyethylene Glycol 3350 and electrolytes for oral solution, USP is supplied in a 5-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. Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor is supplied in a 5-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, 2.97 g potassium chloride, acesulfame potassium 0.2 g and lemon flavor 0.1 g as a white powder. Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor is supplied in a 5-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, 2.97 g potassium chloride, acesulfame potassium 0.2 g and orange flavor 0.4 g as a white powder. • When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L  PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride. Polyethylene Glycol 3350 and electrolytes for oral solution, USP is available in following flavors: Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see Controlled Room Temperature]. Store reconstituted solution of Polyethylene Glycol 3350 and electrolytes for oral solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED - POLYETHYLENE
GLYCOL
3350 AND ELECTROLYTES - UNFLAVORED POWDER, FOR SOLUTION
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR -
POLYETHYLENE
GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR POWDER, FOR SOLUTION
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESWITH ORANGE FLAVOR -
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH ORANGE FLAVOR POWDER,
FOR SOLUTION
Strides Pharma Science Limited
----------
Medication Guide
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION, USP
(pol″ ee eth′ i leen glye′ kol 3350)
Read this Medication Guide before you start taking Polyethylene Glycol
3350 and electrolytes 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
Polyethylene Glycol 3350 and electrolytes for
oral solution?
Polyethylene Glycol 3350 and electrolytes 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 (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
Polyethylene Glycol 3350 and electrolytes
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 Polyethylene Glycol 3350 and electrolytes
for oral solutions:
•
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 Polyethylene Glycol
3350 and electrolytes f

Summary of Product characteristics

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED -
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED POWDER, FOR
SOLUTION
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR -
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR POWDER,
FOR
SOLUTION
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESWITH ORANGE FLAVOR -
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH ORANGE FLAVOR POWDER,
FOR
SOLUTION
STRIDES PHARMA SCIENCE LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POLYETHYLENE GLYCOL
3350 AND ELECTROLYTES FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL
SOLUTION.
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION. INITIAL
U.S. APPROVAL:
1984
INDICATIONS AND USAGE
Polyethylene Glycol 3350 and electrolytes for oral solution, 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) (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration (2.1): (2)
Correct fluid and electrolyte abnormalities before treatment with
Polyethylene Glycol 3350 and
electrolytes for oral solution.
Reconstitute Polyethylene Glycol 3350 and electrolytes for oral
solution with water prior to ingestion.
Do not take oral medications within 1 hour before the start or during
administration of Polyethylene
Glycol 3350 and electrolytes for oral solution. (2.1)
Do not take other laxatives while taking Polyethylene Glycol 3350 and
electrolytes for oral solution.
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 Polyethylene
Glycol 3350 and electrolytes for
oral solution.
Adult Dosing Regimen (2.2): (2)
On day prior to colonoscopy, instruct patients to consume a light
breakfast at least