FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
No additional ingredients, e.g. flavorings, should be added to the solution. Clenz-Lyte™ should be used with caution in patients with severe ulcerative colitis.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Clenz-Lyte™ is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination.
History
There is currently no drug history available for this drug.
Other Information
Clenz-Lyte™ (Polyethylene Glycol 3350 and Electrolytes for Oral Solution) is a white powder in a 4 liter jug for reconstitution, containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride. When dissolved in water to a volume of 4 liters, Clenz-Lyte™ is an isosmotic solution, for oral administration, having a mildly salty taste. Clenz-Lyte™ is administered orally or via nasogastric tube as a gastrointestinal lavage.
Sources
Clenz-lyte Manufacturers
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Paddock Laboratories, Inc.
Clenz-lyte | Paddock Laboratories, Inc.
The recommended dose for adults is 4 liters of Clenz-Lyte™ prior to gastrointestinal examination, as ingestion of this dose produces a satisfactory preparation in over 95% of patients. Ideally, the patient should fast for approximately three or four hours prior to Clenz-Lyte™ administration, but in no case should solid food be given for at least two hours before the solution is given.
Clenz-Lyte™ is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Oral administration is at a rate of 240 mL (8 oz.) every 10 minutes, until the 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric tube administration is at the rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour). The first bowel movement should occur approximately one hour after the start of Clenz-Lyte™ administration.
Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer Clenz-Lyte™ on the evening before the examination, particularly if the patient is to have a barium enema.
Preparation of the solution:Clenz-Lyte™ is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to ensure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.
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