PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
Clinical safety rating: safe
No significant drug interactions Can cause hypernatremia and fluid overload.
Osmotic laxative: PEG-3350 retains water in stool via osmotic effect; electrolytes (potassium, sodium, bicarbonate) prevent electrolyte depletion and maintain fluid balance.
| Metabolism | PEG-3350 is not significantly metabolized; excreted unchanged in feces. Electrolytes are absorbed and regulated by renal function. |
| Excretion | PEG-3350 is eliminated essentially unchanged in feces; less than 1% is absorbed and excreted renally. Electrolytes are absorbed and distributed; potassium is primarily excreted renally (90%), sodium and chloride are excreted renally with regulation by aldosterone, and bicarbonate is converted to CO2 and excreted via lungs. |
| Half-life | The terminal elimination half-life of PEG-3350 is approximately 1.5 hours for the absorbed fraction; the majority is not absorbed and has negligible systemic half-life. Electrolytes have variable half-lives: potassium ~12 hours (renal function dependent), sodium ~6 hours, chloride ~8 hours, bicarbonate ~15 minutes. |
| Protein binding | PEG-3350: negligible binding. Potassium: none. Sodium: none. Chloride: none. Bicarbonate: negligible binding. |
| Volume of Distribution | PEG-3350: Vd approximately 0.1 L/kg (confined to extracellular fluid). Potassium: 0.04 L/kg (primarily intracellular, but distribution is tightly regulated). Sodium: 0.4 L/kg (extracellular). Chloride: 0.2 L/kg (extracellular). Bicarbonate: 0.3 L/kg (extracellular). |
| Bioavailability | PEG-3350: <0.1% absorbed orally; essentially negligible systemic bioavailability. Electrolytes: potassium chloride (100% absorbed), sodium chloride (100% absorbed), sodium bicarbonate (100% absorbed). |
| Onset of Action | Oral administration: bowel cleansing begins within 1-2 hours; full effect typically within 2-4 hours. |
| Duration of Action | Duration of bowel cleansing effect is approximately 2-4 hours after the last dose; the entire colon is usually cleansed within 4-6 hours after starting ingestion. |
Adult dose for colonoscopy preparation: 240 mL (1 glass) orally every 10 minutes until 4 L consumed or rectal effluent is clear. For constipation: 17 g (1 heaping tablespoon) dissolved in 8 oz water orally once daily, not to exceed 7 days.
| Dosage form | FOR SOLUTION |
| Renal impairment | No specific dose adjustment for GFR; use with caution in severe renal impairment (CrCl <30 mL/min) due to risk of electrolyte disturbances; monitor electrolytes and fluid status. |
| Liver impairment | No adjustment required for Child-Pugh Class A or B; use with caution in Class C due to potential fluid shifts and electrolyte imbalance; monitor closely. |
| Pediatric use | Colonoscopy preparation for pediatric patients: 25 mL/kg/hour orally (maximum 1000 mL/hour) until rectal effluent is clear, up to 4 L total. For constipation: 0.5-1.5 g/kg/day orally divided once daily; max 17 g/day. |
| Geriatric use | Start with lower doses for constipation (e.g., 7.5-10 g/day); ensure adequate hydration; monitor electrolytes and renal function due to age-related decline; use with caution in those with unstable blood pressure or cardiac conditions. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Breastfeeding | These agents are minimally absorbed; thus, excretion into breast milk is negligible. M/P ratio not determined. Considered compatible with breastfeeding. |
| Teratogenic Risk | PEG-3350, potassium chloride, sodium bicarbonate, and sodium chloride are not absorbed systemically in significant amounts; therefore, no fetal risk is anticipated. No teratogenic effects have been reported. For all trimesters, minimal to no risk. |
■ FDA Black Box Warning
No FDA boxed warning exists for this combination product, but individual components may have warnings.
| Common Effects | Blurred vision Difficulty in paying attention Dizziness Dryness in mouth Edema swelling Sleepiness Weight gain |
| Serious Effects |
["Gastrointestinal obstruction","Gastric retention","Bowel perforation","Toxic colitis or megacolon","Hypersensitivity to any component","Severe electrolyte abnormalities (e.g., hypernatremia, hypokalemia)"]
| Precautions | ["Risk of serious fluid and electrolyte disturbances","Use caution in patients with renal impairment, cardiac disease, or electrolyte abnormalities","Avoid in patients with GI obstruction, perforation, or toxic colitis","May cause seizures due to electrolyte shifts (especially hyponatremia)"] |
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| Fetal Monitoring | Monitor for diarrhea or electrolyte disturbances in the mother, especially with prolonged use or large volumes. No specific fetal monitoring required. |
| Fertility Effects | No effects on fertility reported or anticipated due to lack of systemic absorption. |