PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
Clinical safety rating: safe
No significant drug interactions Can cause hypernatremia and fluid overload.
Combination of osmotic laxative (PEG-3350, sodium chloride, sodium bicarbonate, potassium chloride) and stimulant laxative (bisacodyl). PEG-3350 causes water retention in colon, increasing stool water content and volume, stimulating peristalsis. Electrolytes maintain fluid/electrolyte balance. Bisacodyl stimulates colonic smooth muscle contraction and inhibits water absorption.
| Metabolism | PEG-3350 is not metabolized; excreted unchanged in feces. Bisacodyl is metabolized in the liver and small intestine to its active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2-methane, by ester hydrolysis. Electrolytes are absorbed or secreted by normal physiological mechanisms. |
| Excretion | PEG-3350 is not absorbed, excreted unchanged in feces. Electrolytes (sodium chloride, sodium bicarbonate, potassium chloride) are absorbed and renally excreted; bisacodyl is primarily excreted as glucuronide conjugates in feces (biliary) and urine (renal). Approximately 95% of bisacodyl is recovered in feces, 5% in urine. |
| Half-life | PEG-3350: not applicable (non-absorbed). Bisacodyl: terminal half-life 8–16 hours; clinical effect peaks within 6–12 hours. |
| Protein binding | PEG-3350: negligible (non-absorbed). Bisacodyl: ~90% bound to plasma proteins. |
| Volume of Distribution | PEG-3350: not distributed (non-absorbed). Bisacodyl: Vd approximately 0.4–0.6 L/kg, indicating moderate tissue distribution. |
| Bioavailability | PEG-3350: negligible systemic absorption (<0.2%). Bisacodyl: oral bioavailability 15–30% due to first-pass metabolism; rectal bioavailability ~50%. |
| Onset of Action | PEG-3350 with electrolytes: 1–2 hours (oral). Bisacodyl: 6–12 hours (oral tablet), 0.25–1 hour (rectal suppository). |
| Duration of Action | PEG-3350 with electrolytes: bowel cleansing effect lasts until evacuation is complete (typically 2–4 hours); bisacodyl: cathartic effect may last up to 6 hours; clinical bowel preparation effects resolve within 24 hours. |
For colonoscopy preparation: Day 1: 4 bisacodyl tablets (5 mg each) orally at 2000. Day 2: 1 liter of PEG-3350 plus electrolytes solution (4 sachets dissolved in 4 liters water) orally at 0800; then 2 liters more over 3-4 hours. Alternatively, split-dose regimen: 2 liters evening before colonoscopy and 2 liters morning of procedure.
| Dosage form | FOR SOLUTION, TABLET, DELAYED RELEASE |
| Renal impairment | Contraindicated in severe renal impairment (CrCl <30 mL/min) due to risk of electrolyte disturbances. In moderate impairment (CrCl 30-50 mL/min): use with caution, monitor electrolytes. No dose adjustment specified by manufacturer for mild impairment. |
| Liver impairment | No specific dose adjustment required for hepatic impairment based on Child-Pugh class. However, use with caution in severe hepatic impairment due to potential for encephalopathy from electrolyte shifts. |
| Pediatric use | Not FDA-approved for children <2 years. For children 2-11 years: PEG-3350 plus electrolytes 75-100 mL/kg/dose orally, up to 4 L, for colonoscopy preparation. Bisacodyl tablets: children 6-11 years: 2.5-5 mg orally at bedtime day before procedure. Weight-based: not standardized; refer to specific pediatric protocols. |
| Geriatric use |
| 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 | Bisacodyl and polyethylene glycol are not excreted in breast milk in significant amounts; M/P ratio unknown. Minimal systemic absorption suggests low risk. Use with caution due to potential gastrointestinal effects in infant. |
| Teratogenic Risk | First trimester: Minimal systemic absorption; no known teratogenic effects. Second/third trimester: Avoid use due to risk of electrolyte imbalance and fluid shifts; not associated with congenital anomalies. |
■ FDA Black Box Warning
WARNING: SERIOUS FLUID AND ELECTROLYTE ABNORMALITIES. There have been reports of significant fluid shifts, severe electrolyte abnormalities (including hypokalemia, hyponatremia), and dehydration in patients treated with this product. The risk is increased in patients with renal insufficiency, electrolyte abnormalities, or those taking concomitant medications that affect electrolytes. Monitor and correct fluid and electrolyte disturbances before use.
| Common Effects | fluid replacement |
| Serious Effects |
["Known hypersensitivity to any component","Gastrointestinal obstruction, ileus, gastric retention, bowel perforation, toxic colitis, toxic megacolon","Significant electrolyte abnormalities (e.g., severe hypokalemia, hyponatremia)","Renal impairment (e.g., creatinine clearance < 30 mL/min) for formulations with high PEG-3350 content (note: this product contains lower PEG dose, but caution still warranted)","Pregnancy (relative contraindication; use only if clearly needed)","Patients with impaired consciousness"]
| Precautions | ["Risk of electrolyte abnormalities and dehydration; correct before use","Use with caution in patients with renal impairment, electrolyte disturbances, or taking diuretics, ACE inhibitors, or NSAIDs","Risk of serious arrhythmias due to electrolyte imbalance","Possible colonic mucosal ulcerations (aphthoid ulcers) with bisacodyl","Gag reflex may be impaired in elderly, debilitated, or patients with swallowing disorders; risk of aspiration","May cause Mallory-Weiss tear or esophageal perforation if vomiting occurs","Monitor for QT prolongation in at-risk patients"] |
Loading safety data…
| Use with caution due to increased risk of electrolyte imbalance and dehydration. No specific dose reduction recommended; however, consider lower volume (2 L) split-dose regimen. Monitor renal function and electrolytes before and after procedure. |
| Fetal Monitoring | Monitor serum electrolytes, renal function, and fluid status. Assess for hypotension, tachycardia, and signs of dehydration. Fetal monitoring if maternal electrolyte disturbances occur. |
| Fertility Effects | No known adverse effects on fertility from components. Osmotic laxatives and stimulant laxatives have no established impact on reproductive function. |