POLYETHYLENE GLYCOL 3350
Clinical safety rating: caution
Comprehensive clinical and safety monograph for POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350).
Osmotic laxative. Polyethylene glycol 3350 is a non-absorbable polymer that retains water in the colon via hydrogen bonding, increasing stool water content and stimulating defecation.
| Metabolism | Not metabolized; excreted unchanged in feces. |
| Excretion | Renal: approximately 20% excreted unchanged; Fecal: approximately 80% eliminated unchanged in feces. |
| Half-life | Terminal elimination half-life is 1-2 hours in patients with normal renal function; prolonged in renal impairment, but clinical impact minimal due to primarily fecal elimination. |
| Protein binding | Minimal protein binding (approximately 0%); not significantly bound to plasma proteins. |
| Volume of Distribution | Vd approximately 0.2-0.5 L/kg; indicates distribution mainly in extracellular fluid and minimal tissue penetration. |
| Bioavailability | Oral bioavailability essentially 0% as it is not absorbed from the gastrointestinal tract; acts locally within the gut lumen. |
| Onset of Action | Oral: 30-60 minutes for bowel cleansing; complete evacuation occurs within 1-4 hours after administration. |
| Duration of Action | Duration of bowel cleansing effect is 4-6 hours post-dose; prolonged if retained, but typically complete evacuation occurs within 4-6 hours. |
17 g (1 capful or packet) dissolved in 4–8 oz (120–240 mL) water, administered orally once daily for constipation; for colonoscopy preparation, 240 g (4 L of solution) ingested at 240 mL every 10–15 minutes.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for any degree of renal impairment; monitor for fluid/electrolyte disturbances. |
| Liver impairment | No dose adjustment required for any Child-Pugh class; caution in severe hepatic disease due to potential fluid overload. |
| Pediatric use | For constipation: 0.5–1.5 g/kg/day (max 17 g/day) dissolved in 4–8 oz water orally once daily; for colonoscopy: 4 g/kg (max 240 g) as 4 L solution. |
| Geriatric use | Initiate at 17 g once daily; monitor for electrolyte imbalances, dehydration, and aspiration risk; reduce dose if renal function impaired, though no specific adjustment required. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350).
| Breastfeeding | Polyethylene glycol 3350 is not absorbed orally and is not expected to pass into breast milk. It is safe for use during breastfeeding. M/P ratio is not applicable due to negligible systemic absorption. |
| Teratogenic Risk | Polyethylene glycol 3350 is not absorbed systemically after oral administration, thus fetal exposure is negligible. No teratogenic effects have been reported in animal studies or human data. It is considered low risk during all trimesters. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Bowel obstruction or ileus","Gastric retention or perforation","Toxic colitis or toxic megacolon","Known hypersensitivity to PEG compounds"]
| Precautions | ["Use no longer than 7 days for constipation without medical advice","Risk of dehydration and electrolyte disturbances, especially in elderly or renal impairment","Caution in patients with ulcerative colitis, toxic megacolon, or gastrointestinal obstruction","Rare reports of Mallory-Weiss tears, esophagitis, or aspiration"] |
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| No specific monitoring is required for maternal or fetal effects. Routine prenatal care is adequate. |
| Fertility Effects | No known effects on fertility. Polyethylene glycol 3350 is not systemically absorbed and does not interfere with reproductive hormones or gamete function. |