POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
Clinical safety rating: caution
Comprehensive clinical and safety monograph for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES (POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES).
Polyethylene glycol 3350 is an osmotic laxative that acts by retaining water in the stool, increasing stool volume, and stimulating colonic peristalsis. Electrolytes (sodium sulfate, potassium sulfate, magnesium sulfate) are included to maintain fluid and electrolyte balance and prevent shifts.
| Metabolism | Polyethylene glycol 3350 is not significantly metabolized; it is excreted unchanged in feces and urine. Electrolytes are absorbed and metabolized according to normal physiological pathways. |
| Excretion | Primarily fecal (unchanged); minimal renal excretion (<2%) as intact polymer. Electrolytes absorbed and renally excreted. |
| Half-life | Not applicable; PEG 3350 is not metabolized and is eliminated non-kinetically. Clinical effect occurs during colonic transit; residual drug cleared within 24–48 hours post-dose. |
| Protein binding | PEG 3350: <1% bound to plasma proteins. |
| Volume of Distribution | PEG 3350: 0.58 L/kg (confined to extracellular fluid; minimal tissue penetration). |
| Bioavailability | Oral: <0.06% for PEG 3350 (systemic absorption negligible). Electrolytes fully absorbed. |
| Onset of Action | Oral: 1–2 hours for first bowel movement; complete evacuation usually within 4–6 hours. |
| Duration of Action | Bowel cleansing effect lasts 4–6 hours (single dose); residual effects may persist up to 24 hours. |
4 liters of PEG-3350 and electrolytes solution orally as a single dose for colonoscopy preparation; alternative split-dose regimen: 2 liters evening before and 2 liters morning of procedure. For constipation: 17 g (1 heaping tablespoon) dissolved in 8 oz water once daily, up to 3 days.
| Dosage form | FOR SOLUTION |
| Renal impairment | Contraindicated in patients with GFR < 30 mL/min/1.73 m² due to risk of electrolyte abnormalities and fluid overload. For GFR 30-60: use with caution, monitor electrolytes and volume status; consider split-dose regimen. |
| Liver impairment | No specific Child-Pugh based dose adjustments; use with caution in severe hepatic impairment due to risk of electrolyte disturbances and fluid shifts. |
| Pediatric use | For colonoscopy: 4 L if ≥ 12 years old; for constipation: 0.5-1.5 g/kg/day (max 17 g/day) in children ≥ 6 months. Safety and efficacy not established for colonoscopy in children < 12 years; alternative polyethylene glycol products available. |
| Geriatric use | Use with caution due to increased risk of electrolyte imbalance, aspiration, and fluid overload. Consider split-dose regimen, monitor renal function and electrolytes. Lower starting dose for constipation: 8.5 g daily. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES (POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES).
| Breastfeeding | Excretion into breast milk unknown; polyethylene glycol is minimally absorbed systemically. Considered likely compatible with breastfeeding due to low absorption. |
| Teratogenic Risk | Insufficient human data; animal studies not conducted. Use during pregnancy only if clearly needed. No known teratogenicity from limited reports. |
| Fetal Monitoring |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Gastrointestinal obstruction","Gastric retention","Bowel perforation","Toxic colitis","Toxic megacolon","Ileus","Known hypersensitivity to any component"]
| Precautions | ["Risk of fluid and electrolyte abnormalities","Serious arrhythmias in patients with pre-existing electrolyte disturbances","Seizures","Renal impairment","Aspiration risk in patients with impaired gag reflex","Colonic mucosal ulcerations"] |
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| Monitor maternal hydration status, serum electrolytes, and renal function during prolonged use. Fetal heart rate monitoring not required unless maternal electrolyte imbalance occurs. |
| Fertility Effects | No known adverse effects on fertility. |