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COLYTE™
R & C
PEG-3350 - Electrolytes
Colon Electrolyte Lavage Preparation
 
Action And Clinical Pharmacology: Colyte cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or secretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance. tag_IndicationsIndications

Indications And Clinical Uses: For bowel cleansing prior to colonoscopy or barium enema x-ray examination or surgical procedures requiring a clean colon. PEG lavage solution is also indicated for the treatment of constipation and impaction in the elderly and has been used occasionally in children.

Contra-Indications: Patients with ileus, gastric retention, bowel perforation, gastrointestinal obstruction, toxic colitis and toxic megacolon. tag_WarningWarnings

Manufacturers' Warnings In Clinical States: No additional flavorings or ingredients may be added to the solution. Colyte should be used with caution in patients with severe ulcerative colitis.

Precautions: Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of Colyte, 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 Colyte.

When it is used in children, caution should be exercised to avoid dehydration.

Drug Interactions: Oral medications administered within 1 hour of the start of administration of Colyte may be flushed from the gastrointestinal tract and not absorbed.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term carcinogenic and reproductive studies with animals have not been performed.

Pregnancy: Animal reproduction studies have not been conducted with Colyte, and it is not known whether Colyte can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Colyte should be given to a pregnant patient only if clearly needed.

Children: PEG lavage solution has been used for bowel cleansing and the treatment of constipation and fecal impaction in children. Treatment and dosage should be monitored by a physician.

Adverse Reactions: Nausea, abdominal fullness, and bloating are the most frequent adverse effects, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse effects are transient.

Isolated cases of urticaria, rhinorrhea and dermatitis have been reported which may represent allergic reactions.

Dosage And Administration: Prior to gastrointestinal examination or procedure: Colyte can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A 1-hour waiting period after the appearance of clear liquid stools should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Colyte administration.

Oral: The recommended adult oral dose is 240 mL every 10 minutes (see Information for Patients). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 to 4 L.

Nasogastric Tube: Colyte is administered at a rate of 20 to 30 mL/minute (1.2 to 1.8 L/hour).

Preparation of Solution: Add tap water to fill line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No additional flavorings or ingredients may be added to the solution.)

Information for the Patient: Colyte produces a watery stool which cleanses the bowel prior to examination.

For best results, no solid food should be consumed during the 3 to 4 hour period before Colyte consumption. In no case should solid foods be ingested 3 hours before Colyte administration.

The rate of administration is 240 mL (8 oz) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously.

The first bowel movement should occur approximately 1 hour after the start of Colyte administration. Administration of Colyte should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3 to 4 L, although more or less may be required in some patients. The unused portion should be discarded.

Chronic Constipation: 240 to 480 mL/day orally or as recommended by a physician.

Fecal Impaction: Fecal impaction should only be treated by a physician. Recommended adult dose is 2 to 3 L orally, over a 3 to 4 hour period.

Children: Dosage should be adjusted bearing in mind the weight of the child.

Availability And Storage: Each disposable 4 L jug contains: 240 g polyethylene glycol 3350, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate 22.72 g.

After reconstitution of water-soluble components each Colyte preparation delivers the following, in g/L: polyethylene glycol 3350 60.00, sodium chloride 1.46, potassium chloride 0.745, sodium bicarbonate 1.68, sodium sulfate (anhydrous) 5.68. The reconstituted solution is isosmotic and has a mild fruit flavor.

Reconstituted solution should be used within 48 hours after mixing if stored at room temperature. Refrigerated solution must be used within 30 days. Discard unused portion.

Note: Flavoring for Colyte is premixed with powder inside jug.