General Advise all patients to hydrate adequately before, during, and after the use of PegLyte® Powder. Use of PegLyte® Powder is not recommended when abdominal pain, nausea, or vomiting are present. Unconscious or semiconscious patients should be observed during the administration of PegLyte® Powder 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 PegLyte® Powder for more than 1 week, unless recommended by a physician. The safety of long term use of PEG plus electrolytes, like PegLyte® Powder, is unknown. No additional flavorings or ingredients may be added to the solution.
Cardiovascular 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 PegLyte® Powder 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 PegLyte® Powder, 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 PegLyte® Powder.
When a large volume of PegLyte® Powder is used for colon preparation, if a patient experiences severe bloating, distension, or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms subside.
When used for the treatment of constipation, if diarrhea occurs, the use of PegLyte® Powder 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 has 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), PegLyte® Powder 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), 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 PegLyte® Powder, and it is also not known whether PegLyte® Powder can affect reproductive capacity or harm the fetus when administered to a pregnant patient. PegLyte® Powder should be given to a pregnant patient only if clearly needed.
Breastfeeding 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 PegLyte® Powder is administered to a breastfeeding woman.
Pediatrics:
Safety and effectiveness of PegLyte® Powder in children have not been established.
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 PegLyte® Powder Prescribing Information Page 6 of 20 shifts are more risky. 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 Reaction Overview The most frequent adverse reactions, occurring in up to 50% of patients taking 4 L of PegLyte® Powder, are nausea, abdominal fullness, and bloating. Abdominal cramps, vomiting, and anal irritation occur less frequently.
These adverse effects are transient. The most frequent adverse reactions occurring in up […]