PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
Clinical safety rating
safeNo 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. |
| Molecular Weight | PEG-3350: ~3500 Da (range 3010-3680); Sodium Chloride: 58.44; Sodium Bicarbonate: 84.01; Potassium Chloride: 74.55; Bisacodyl: 361.39 |
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 | 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. |
| 1st trimester | Bisacodyl and PEG-3350 with electrolytes are generally avoided in the first trimester unless clearly necessary. Stimulant laxatives like bisacodyl may theoretically increase uterine irritability; osmotic laxatives are preferred. |
| 2nd trimester | May be used with caution during the second trimester for short-term treatment of constipation when dietary measures fail. Minimal systemic absorption of PEG-3350 and bisacodyl is expected. |
| 3rd trimester | Use with caution in the third trimester; avoid prolonged use. Risk of electrolyte disturbances in mother and fetus; bisacodyl may rarely cause uterine contractions. |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Placental transfer | Minimal placental transfer expected for PEG-3350 due to high molecular weight (average range ~3500 Da); bisacodyl is poorly absorbed and its active metabolite (BHPM) has low systemic exposure, limiting placental crossing. |
| Breastfeeding | PEG-3350 and electrolytes are minimally absorbed and considered compatible with breastfeeding. Bisacodyl is also poorly absorbed; however, its active metabolite may be excreted in milk in small amounts. Monitor infant for diarrhea or abdominal discomfort. |
| Lactation Rating | L2: Limited data - probably compatible (safest options: PEG-3350 alone or with electrolytes; bisacodyl used occasionally and at low doses is considered acceptable). |
| 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. |
| 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. |
■ 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 |
Gastrointestinal obstructionAcute surgical abdomen (e.g., appendicitis, peritonitis)Ileus or intestinal perforationSevere inflammatory bowel disease (e.g., toxic colitis)Hypersensitivity to any componentSevere dehydration or electrolyte disturbances (before correction)
| 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 |
| Food/Dietary | Avoid solid foods, dairy, and red/purple colored liquids during preparation. Only clear liquids (water, clear broth, apple juice, gelatin, tea or coffee without cream) are permitted until after the procedure. |
| Clinical Pearls | This combination is used for colonoscopy preparation. Ensure adequate hydration and renal function assessment; avoid in patients with ileus, GI obstruction, or significant electrolyte abnormalities. Bisacodyl is a stimulant laxative that may cause cramping. Administer in divided doses as per protocol. |
| Patient Advice | Drink plenty of clear liquids to stay hydrated. · Follow the exact dosing schedule provided by your doctor. · Expect frequent, watery bowel movements; stay near a restroom. · Do not eat solid foods during the preparation; only clear liquids. · Notify your doctor if you experience severe abdominal pain, vomiting, or signs of dehydration. |
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