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COLYTE is a brand name for Polyethylene Glycol 3350, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .........................................................................3 CONTRAINDICATIONS .............................................................................................3 WARNINGS AND PRECAUTIONS.............................................................................4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
General Use of Colyte® is not recommended when abdominal pain, nausea, or vomiting are present Unconscious or semiconscious patient should be observed during the administration of Colyte® via nasogastric tube. A laxative should not be taken within 2 hours of another medicine because the desired effect of the other medicine may be reduced.
For use in the treatment of constipation: Patients presenting with complaints of constipation should have a thorough medical history and physical examination to detect associated metabolic, endocrine and neurogenic conditions, and medications.
A diagnostic evaluation should include a structural examination of the colon. Do not take Colyte® for more than 1 week, unless recommended by a physician. The safety of long term use of PEG plus electrolytes, like Colyte®, is unknown.
No additional flavorings or ingredients may be added to the solution. Colyte® may result in a potential interactive effect when used with starch-based food thickeners. The PEG ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.
This warning applies to all polyethylene glycol (PEG) containing-products. Advise all patients to hydrate adequately before, during, and after the use of Colyte®. Cardiac Arrhythmias There have been rare reports of serious cardiac arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation.
, patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.
Gastrointestinal Colyte® should be used with caution in patients with ulcerative colitis (UC). Patients suffering from UC or from an acute exacerbation of inflammatory bowel disease have not been studied. Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration of Colyte®, especially if it is administered via nasogastric tube.
If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out those conditions before administration of Colyte®. When a large volume of Colyte® is used for colon preparation, if a patient experiences severe Colyte® Prescribing Information Page 5 of 19 bloating, distension or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms abate.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
When used for the treatment of constipation, if diarrhea occurs, the use of Colyte® should be discontinued. , bisacodyl). If patients develop severe abdominal pain and/or rectal bleeding, immediate evaluation and close medical attention should be provided.
Immune Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products which may represent allergic reactions. Neurologic Use of a 4 L volume of PEG-based colon preparation products have resulted in reports of generalized tonic-clonic seizures in patients with no prior history of seizures.
Electrolyte abnormalities, such as hyponatremia and hypokalemia, as well as severe vomiting and excessive beverage consumption have been associated with these cases. A correction of fluid and electrolyte abnormalities resolved the neurologic irregularity.
Therefore, in patients with known or suspected hyponatremia, or in patients using concomitant medications that increase the risk of electrolyte abnormalities (such as diuretics), Colyte® should be used with caution. In these patients, baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) should be monitored.
Renal The close monitoring of patients with impaired renal function should be performed, especially if severe vomiting occurs. Measurement of electrolytes (sodium, potassium, calcium,) and BUN and creatinine is desirable. Mild hypokalemia was reported in a patient treated for constipation during 1 month who concurrently received diuretics.
Hyperphosphatemia was reported during long term treatment with PEG-products.
Special Populations Pregnant Women:
Animal reproduction studies have not been conducted with Colyte®, and it is also not known whether Colyte® can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Colyte® should be given to a pregnant patient only if clearly needed.
Nursing Women:
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 Colyte® is administered to a nursing woman.
Pediatrics:
Safety and effectiveness of Colyte® in children have not been established.
Colyte® Prescribing Information Page 6 of 19 Geriatrics (> 60 years of age):
There are isolated reports of serious post-marketing events following the administration of large volumes of PEG-based products for colon preparation in patients over 60 years of age (acute pulmonary edema after vomiting and aspirating the PEG- based solution, asystole, esophageal perforation, and upper GI bleeding from a Mallory-Weiss tear).
Caution is required in patients with renal and cardiac dysfunction in whom fluid and electrolyte shifts are of extra risk. Monitoring and Laboratory Tests Repeated or prolonged use of PEG-based products may result in electrolyte imbalance; monitoring of serum electrolytes including phosphate level is advised.
ADVERSE REACTIONS Adverse Drug Re action Overview The most frequent adverse reactions, occurring in up to 50% of patients taking 4 L of Colyte® solution, are nausea, abdominal fullness and […]