PEG 3350 AND ELECTROLYTES
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PEG 3350 AND ELECTROLYTES (PEG 3350 AND ELECTROLYTES).
PEG 3350 is an osmotic laxative that retains water in the bowel lumen via hydrogen bonding, increasing fecal water content and stimulating peristalsis. Electrolytes (sodium sulfate, potassium chloride, sodium bicarbonate, magnesium sulfate) prevent significant fluid and electrolyte shifts by maintaining isotonicity.
| Metabolism | PEG 3350 is not metabolized; it is excreted unchanged in feces. Electrolytes are absorbed or excreted via renal and gastrointestinal routes; sodium and potassium are renally eliminated primarily. |
| Excretion | Primarily fecal (96–98%) as unabsorbed PEG 3350; electrolytes absorbed are excreted renally (sodium, potassium) and via feces (biliary excretion negligible). |
| Half-life | Not applicable; PEG 3350 undergoes minimal systemic absorption (<0.2%), thus no meaningful terminal half-life. Systemic half-life of absorbed fraction is <2 hours. |
| Protein binding | Negligible (<1%); PEG 3350 does not bind to plasma proteins due to its large molecular weight and hydrophilic nature. |
| Volume of Distribution | Not clinically meaningful; Vd is essentially limited to gastrointestinal lumen (estimated <0.1 L/kg) due to minimal systemic absorption. |
| Bioavailability | Oral: <0.2% (systemic absorption of PEG 3350 is negligible). |
| Onset of Action | Oral: 1–2 hours (first bowel movement); peak effect at 2–4 hours. Rectal (enema): 5–15 minutes. |
| Duration of Action | Oral: 4–6 hours (bowel cleansing persists until colon emptied). Rectal: 30–60 minutes. Note: Duration depends on dose and individual colonic transit. |
4 liters orally of the reconstituted solution administered as a single dose at 240 mL every 10 minutes or 1 to 1.5 L/hour until rectal effluent is clear. Alternatively, 240 mL every 10 minutes until 4 L consumed.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (eGFR >30 mL/min). For severe renal impairment (eGFR <30 mL/min or dialysis), use with caution due to risk of fluid and electrolyte disturbances; monitor electrolytes and fluid status. |
| Liver impairment | No specific dose adjustment for hepatic impairment; use with caution in severe hepatic impairment due to potential fluid shifts. |
| Pediatric use | Children 6 months to 16 years: 25 mL/kg/hour orally until rectal effluent is clear (maximum 1 L/hour). Total dose: typically 25-40 mL/kg, not to exceed 4 L. Safety and efficacy in infants <6 months not established. |
| Geriatric use | No specific dose adjustment; use with caution due to increased risk of aspiration, electrolyte imbalance, and volume depletion. Monitor renal function and electrolytes before and after administration. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PEG 3350 AND ELECTROLYTES (PEG 3350 AND ELECTROLYTES).
| Breastfeeding | Excretion into breast milk is unlikely due to minimal systemic absorption. M/P ratio not determined; considered compatible with breastfeeding. Use with caution in nursing mothers with gastrointestinal disorders. |
| Teratogenic Risk | PEG 3350 and electrolytes are minimally absorbed systemically, posing negligible teratogenic risk. No human studies; animal reproduction studies not conducted. Considered safe throughout pregnancy due to lack of systemic exposure. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Absolute: Bowel obstruction, ileus, gastric retention, gastrointestinal perforation, toxic colitis, toxic megacolon","Relative: Severe renal impairment (creatinine clearance <30 mL/min), electrolyte abnormalities (e.g., hypernatremia, hypokalemia), severe heart failure (NYHA III/IV), active seizures or epilepsy, known hypersensitivity to any component"]
| Precautions | ["Risk of electrolyte imbalance (e.g., hypernatremia, hypokalemia) in patients with renal impairment, heart failure, or on diuretics","Aspiration risk in patients with impaired gag reflex, dysphagia, or reduced consciousness","GI adverse effects: nausea, bloating, cramping, vomiting; severe reactions like colitis or ischemic colitis rare","Seizures: associated with electrolyte abnormalities, especially hyponatremia, or in patients with underlying CNS disorders","Cardiac arrhythmias (QT prolongation) due to electrolyte disturbances","Dehydration and volume depletion; monitor fluid intake"] |
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| Monitor maternal fluid and electrolyte balance, especially with prolonged use. No specific fetal monitoring required due to lack of systemic exposure. |
| Fertility Effects | No known effects on fertility. Systemic absorption is negligible; reproductive toxicity is unlikely. |