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JAMPLYTE 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 JAMPLyte is not recommended when abdominal pain, nausea, or vomiting are present. • Unconscious or semiconscious patient should be observed during the administration of JAMPLyte 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.
No additional flavorings or ingredients may be added to the solution. Advise all patients to hydrate adequately before, during, and after the use of JAMPLyte. 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 JAMPLyte 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 JAMPLyte, 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 JAMPLyte. If a patient experiences severe bloating, distension, or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms abate.
, 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 JAMPLyte Prescribing Information Page 5 of 15 reported with PEG/electrolytes-based lavage products that have the same medicinal ingredients as JAMPLyte but with different brand names.
This may represent allergic reactions. Neurologic PEG/electrolytes-based gastrointestinal lavage 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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), JAMPLyte 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.
Special Population Pregnant Women:
Animal reproduction studies have not been conducted with JAMPLyte, PEG/electrolytes-based gastrointestinal lavage products, like JAMPLyte, and it is also not known whether JAMPLyte can affect reproductive capacity or harm the fetus when administered to a pregnant patient.
JAMPLyte 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 JAMPLyte is administered to a breastfeeding woman.
Paediatrics:
Safety and effectiveness of JAMPLyte in children have not been established.
Geriatrics (> 60 years of age):
There are isolated reports of serious post-marketing events following the administration of PEG/electrolytes-based colon preparation products 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 Test JAMPLyte Prescribing Information Page 6 of 15 Monitoring of serum electrolytes is advised.
ADVERSE REACTIONS Adverse Drug Reaction Overview The most frequent adverse reactions, occurring in up to 50% of patients who have undergone PEG/electrolytes-based gastrointestinal lavage products, are nausea, abdominal fullness, and bloating.
Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse effects are transient. Post-Market Adverse Drug_Reactions The following rare adverse events have been reported following administration of a PEG/electrolytes-based gastrointestinal lavage: Cardiovascular: bradycardia, acute pulmonary edema, hypotension Eye: sensitivity to light, painful irritated eyes Gastrointestinal: rectal bleeding (occult blood in stool), sores in mouth, Ischemic Colitis (when used in conjunction with a stimulant laxative) General and Administration Site Conditions: chills, loss of appetite Hematologic: anemia Metabolism and Nutrition: fluid imbalance, hypoglycaemia Musculoskeletal and Connective Tissue: muscle pain Nervous System: headaches, unconscious, coma, seizures, shakes Psychiatric: confused feeling, disorientation Respiratory, Thoracic and Mediastinal: aspiration Skin and Subcutaneous Tissue: oily hair and skin, facial swelling, leg swelling Isolated cases of urticaria, rhinorrhea, and dermatitis have been reported, […]