Flavor packs are for use only
in combination with the contents of the accompanying 1 gallon container. No other
additional ingredients (e.g., flavorings) should be added to the solution.
Colyte with flavor packs should be used with caution in patients with severe
Patients with impaired gag
reflex, unconscious or semiconscious patients and patients prone to
regurgitation or aspiration should be observed during the administration of
Colyte® with flavor packs, especially if it is administered via nasogastric
Serious Fluid and Serum
Advise patients to hydrate
adequately before, during, and after the use of Colyte. Use caution in patients
with congestive heart failure when replacing fluids. If a patient develops
significant vomiting or signs of dehydration including signs of orthostatic
hypotension after taking Colyte, consider performing post-colonoscopy lab tests
(electrolytes, creatinine, and BUN) and treat accordingly. Fluid and
electrolyte disturbances can lead to serious adverse events including cardiac
arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities
should be corrected before treatment with Colyte.
In addition, use caution when
prescribing Colyte for patients who have conditions, or who are using
medications, that increase the risk for fluid and electrolyte disturbances or
may increase the risk of adverse events of seizure, arrhythmia, and renal
There have been rare reports of
serious arrhythmias associated with the use of ionic osmotic laxative products
for bowel preparation. Use caution when prescribing Colyte for patients at increased
risk of arrhythmias (e.g., 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
There have been reports of
generalized tonic-clonic seizures and/or loss of consciousness associated with
use of bowel preparation products in patients with no prior history of
seizures. The seizures cases were associated with electrolyte abnormalities
(e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low
serum osmolality. The neurologic abnormalities resolved with correction of
fluid and electrolyte abnormalities.
Use caution with prescribing
Colyte for patients with a history of seizures and in patients at increased
risk of seizure, such as patients taking medications that lower the seizure
threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol
or benzodiazepines, or patients with known or suspected hyponatremia.
Use caution when prescribing
Colyte for patients with impaired renal function or patients taking concomitant
medications that may affect renal function (such as diuretics, angiotensin
converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal
anti-inflammatory drugs). Advise these patients of the importance of adequate
hydration, and consider performing baseline and post-colonoscopy laboratory
tests (electrolytes, creatinine, and BUN) in these patients.
Colonic Mucosal Ulcerations and
Administration of osmotic
laxative products may produce colonic mucosal aphthous ulcerations, and there
have been reports of more serious cases of ischemic colitis requiring
hospitalization. Concurrent use of stimulant laxatives and Colyte may increase
the risk. The potential for mucosal ulcerations resulting from the bowel
preparation should be considered when interpreting colonoscopy findings in
patients with known or suspected inflammatory bowel disease (IBD).
Use in Patients with
Significant Gastrointestinal Disease
If gastrointestinal obstruction
or perforation is suspected, perform appropriate diagnostic studies to rule out
these conditions before administering Colyte. Use caution in patients with
severe active ulcerative colitis.
Use with caution in patients
with impaired gag reflex and patients prone to regurgitation or aspiration.
Such patients should be observed during administration of Colyte, especially if
it is administered via nasogastric tube.
Not for Direct Ingestion
The contents of each jug must
be diluted with water to final volume of 4 liters (4L) and ingestion of
additional water is important to patient tolerance. Direct ingestion of the
undissolved powder may increase the risk of nausea, vomiting, dehydration, and
obstruction or perforation is suspected appropriate studies should be performed
to rule out these conditions before administration of colyte® with flavor
Information for Patients
(see Medication Guide
Colyte® with flavor packs
produces a watery stool which cleanses the bowel prior to examination.
For best results, no solid
food should be ingested during the 3 – 4 hour period prior to the initiation of
Colyte with flavor packs administration. In no case should solid foods be eaten
within 2 hours of drinking Colyte with flavor packs.
The rate of administration is
240 mL (8 fl. oz.) every 10 minutes. Rapid drinking of each portion is
preferred rather than drinking small amounts continuously.
The first bowel movement
should occur approximately one hour after the start of Colyte® with flavor
Administration of Colyte with
flavor packs should be continued until the watery stool is clear and free of
solid matter. This normally requires the consumption of approximately 3 - 4
liters (3 - 4 quarts), although more or less may be required in some patients.
The unused portion should be discarded.
Consume water or clear liquids
during the bowel preparation and after completion of the bowel preparation up
until 2 hours before the time of the colonoscopy.
Impairment of Fertility
Studies to evaluate
carcinogenesis or mutagenic potential or potential to adversely affect male or
female fertility have not been performed.
Pregnancy - Category C
Animal reproduction studies
have not been conducted with Colyte to evaluate the carcinogenic potential. It
is not known whether Colyte can cause fetal harm when administered to a
pregnant woman or can affect reproductive capacity. Colyte should be given to a
pregnant woman only if clearly needed.
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.
The safety and effectiveness
of Colyte in pediatric patients have not been established.
Published literature contains
isolated reports of serious adverse reactions following the administration of
PEG-ELS products in patients over 60 years of age. These adverse events include
upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole,
sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrate on chest
x-ray after vomiting and aspirating PEG.