| PEGLYTE™ |
|Gastrointestinal Lavage |
|Action And Clinical Pharmacology: Peglyte 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. Peglyte should be used with caution in patients with severe ulcerative colitis.
Precautions: Patients with impaired gag reflex, unconcious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of Peglyte, 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 Peglyte.
When it is used in children, caution should be excercised to avoid dehydration.
Drug Interactions: Oral medications administered within 1 hour of the start of administration of Peglyte 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 Peglyte, and it is not known whether Peglyte can affect reproductive capacity or harm the fetus when administered to a pregnant patient. Peglyte 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.
Information for the Patient: Peglyte 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 Peglyte consumption. In no case should solid foods be ingested 3 hours before Peglyte administration.
The rate of administration is 240 mL 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 Peglyte administration. Administration of Peglyte 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.
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: Peglyte 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 Peglyte administration.
Oral: The recommended adult oral dose is 240 mL every 10 minutes (see Precautions, Information for the Patient). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 to 4 L.
Nasogastric Tube: Peglyte 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.)
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: Powder: Each 280 g container of powder contains: polyethylene glycol 3350 238.18 g, sodium sulfate 22.96 g, sodium bicarbonate 6.76 g, sodium chloride 5.85 g, potassium chloride 3.05 g, flavors 2.55 g and sodium saccharin 0.55 g.
When reconstituted to 4 L with water, each 1 L of solution contains: polyethylene glycol 3350 17.8 mmol, sodium 126 mmol, potassium 10.2 mmol, chloride 35.3 mmol, sulfate 40.4 mmol, bicarbonate 20.1 mmol. The reconstituted solution has a mild fruit flavor.
Containers of 4 L. Reconstituted solution should be used within 48 hours after mixing if stored at room temperature. If kept refrigerated (2 to 8°C), use within 30 days. Discard unused portion.
Solution: Each 1 L of solution contains: polyethylene glycol 17.8 mmol, sodium 126 mmol, potassium 10.2 mmol, chloride 35.3 mmol, sulfate 40.4 mmol, bicarbonate 20.1 mmol supplied as polyethylene glycol 59.55 g, sodium sulfate 5.74 g, sodium bicarbonate 1.69 g, sodium chloride 1.46 g, potassium chloride 0.76 g. The solution has a mild fruit flavor.
Containers of 1 L, cartons of 8, wrapped in groups of 4. Once opened the solution should be used within 48 hours if stored at room temperature. If kept refrigerated (2 to 8°C) use within 30 days. Discard unused portion.
Note: Flavoring for Peglyte is premixed with powder inside jug.