CoLyte
FDA Approves Dotarem, a New MRI Agent »
"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
CoLyte
WARNINGS
Flavor packs are for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. colyte (peg electrolytes solution) ® with flavor packs should be used with caution in patients with severe ulcerative colitis.
PRECAUTIONS
General
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 (peg electrolytes solution) , especially if it is administered via nasogastric tube.
If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of colyte® with flavor packs (peg electrolytes solution) .
Patient Information
colyte® with flavor packs (peg electrolytes solution) 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 (peg electrolytes solution) administration. In no case should solid foods be eaten within 2 hours of drinking colyte® with flavor packs (peg electrolytes solution) .
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 packs (peg electrolytes solution) administration.
Administration of colyte® with flavor packs (peg electrolytes solution) 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.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies to evaluate carcinogenic 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® with flavor packs (peg electrolytes solution) , and it is not known whether colyte (peg electrolytes solution) ® with flavor packs can affect reproductive capacity or harm the fetus when administered to a pregnant patient. colyte® with flavor packs (peg electrolytes solution) should be given to a pregnant patient only if clearly needed.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
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.
Last reviewed on RxList: 5/4/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional CoLyte Information
CoLyte - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.






