PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Clinical safety rating
safeNo significant drug interactions Can cause hypernatremia and fluid overload.
Osmotic laxative. Polyethylene glycol (PEG) 3350 and sodium sulfate act as osmotic agents that retain water in the colon, increasing stool water content and inducing diarrhea. Ascorbic acid and sodium ascorbate enhance colonic fluid retention and secretion through organic anion transporters.
| Metabolism | Not metabolized; excreted unchanged in feces. |
| Excretion | Primarily fecal (≥96%) as intact PEG 3350; absorbed fraction of electrolytes and ascorbate renally eliminated. Renal excretion of PEG <0.2%. |
| Half-life | PEG 3350: Not applicable (minimal systemic absorption). Ascorbic acid: ~10-20 hours (dose-dependent, renal saturable reabsorption). |
| Protein binding | PEG 3350: Negligible; Ascorbic acid: ~25% bound to albumin. |
| Volume of Distribution | PEG 3350: ~0 L/kg (confined to GI tract); Ascorbic acid: ~0.4-0.6 L/kg (distributes into total body water). |
| Bioavailability | Oral: PEG 3350 <0.06% (systemic); Ascorbic acid: 80-90% at low doses, decreases with high doses (saturable absorption). |
| Onset of Action | Oral: First bowel movement typically within 1-4 hours; complete colonic evacuation occurs within 2-6 hours. |
| Duration of Action | Bowel cleansing effect persists for approximately 2-4 hours after last dose; residual effects may last up to 12 hours. |
| Molecular Weight | 3350 |
Adults: 240 mL (or 2 sachets) reconstituted to 1 L water, administered orally or via nasogastric tube, in divided doses (e.g., 240 mL every 10-15 minutes) to a total volume of 1 L, followed by additional clear liquids as needed. For colonoscopy preparation, the typical regimen is a split-dose: first half (500 mL) in the evening before procedure, second half (500 mL) at least 3-5 hours before procedure.
| Dosage form | FOR SOLUTION |
| Renal impairment | Contraindicated in patients with creatinine clearance < 30 mL/min due to risk of fluid and electrolyte disturbances. For GFR 30-60 mL/min: no dose adjustment required but monitor electrolytes and fluid status closely. For GFR > 60 mL/min: no adjustment needed. |
| Liver impairment | No specific dose adjustment recommended for hepatic impairment. Use with caution in patients with severe hepatic impairment (Child-Pugh class C) due to potential fluid overload and electrolyte imbalances; consider alternative bowel preparation. |
| Pediatric use | Children (≥6 months to 18 years): For colonoscopy, dose based on age and weight: 6 months to 1 year (7-10 kg): 125 mL (1/4 sachet) in 250 mL water; 1-2 years (10-13 kg): 250 mL (1/2 sachet) in 500 mL water; 2-4 years (13-17 kg): 375 mL (3/4 sachet) in 750 mL water; 4-12 years (17-33 kg): 500 mL (1 sachet) in 1 L water; >12 years: 1 L (2 sachets) in 2 L water. Administer orally in divided doses (e.g., 25-50 mL/kg/h) until clear rectal effluent. Not recommended in infants <6 months. |
| Geriatric use | Elderly patients (≥65 years): No dose adjustment required but use with caution due to increased risk of fluid and electrolyte disturbances, dehydration, and renal impairment. Monitor hydration status, electrolytes, and renal function (creatinine and BUN) before and after administration. Consider split-dose regimen to minimize volume load and ensure adequate hydration. |
| 1st trimester | Limited human data; animal studies not conducted. Generally avoided due to unknown risks during organogenesis. Use only if clearly needed. |
| 2nd trimester | No evidence of fetal harm from limited use. May be used if benefits outweigh risks. |
| 3rd trimester | Minimal systemic absorption; unlikely to affect fetus. Safe for bowel preparation prior to delivery. |
Clinical note
No significant drug interactions Can cause hypernatremia and fluid overload.
| FDA category | Animal |
| Placental transfer | Negligible due to high molecular weight and poor absorption; not expected to cross placenta in significant amounts. |
| Breastfeeding | Minimal systemic absorption due to large molecular size and poor oral bioavailability. Excretion into breast milk is negligible. Considered compatible with breastfeeding. |
| Lactation Rating | L1 (Compatible) |
| Teratogenic Risk | PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid combination is used for bowel cleansing prior to colonoscopy. There are no adequate and well-controlled studies in pregnant women. Animal reproductive studies have not been conducted. Based on the mechanism of action and lack of systemic absorption of the polyethylene glycol and sulfate components, the risk of teratogenicity is considered low. However, dehydration and electrolyte imbalances secondary to the purgative effect could theoretically pose risks, particularly in the first trimester. The FDA pregnancy category is not assigned; however, most sources consider it low risk with cautious use if clearly needed. |
| Fetal Monitoring | Monitor for signs of dehydration (e.g., thirst, dry mouth, dizziness, oliguria) and electrolyte imbalances (e.g., hyponatremia, hypokalemia, hypernatremia, hyperphosphatemia). Assess serum electrolytes, renal function, and hydration status before and after administration. Fetal monitoring (e.g., fetal heart rate) is not specifically required but should be considered if the mother develops significant electrolyte disturbances or dehydration. In pregnant women, additional monitoring for uterine contractions or preterm labor is prudent given the gastrointestinal stress. |
| Fertility Effects | No studies have been conducted to evaluate the impact on fertility. The drug combination is used for acute bowel cleansing and is not expected to have long-term effects on fertility. However, transient electrolyte disturbances could theoretically affect ovulation or spermatogenesis, but no clinical data support this. Fertility effects are considered negligible with single or intermittent use. |
■ FDA Black Box Warning
None.
| Common Effects | fluid replacement |
| Serious Effects |
Gastrointestinal obstructionGastric retentionBowel perforationToxic colitisMegacolonIleus
| Precautions | Risk of electrolyte abnormalities (especially hypernatremia, hypokalemia) and fluid imbalance, Risk of cardiac arrhythmias, including QT prolongation, in patients with electrolyte disorders or taking QT-prolonging drugs, Risk of renal impairment, especially in patients with pre-existing kidney disease or taking nephrotoxic drugs, Seizures secondary to electrolyte abnormalities, Serious adverse reactions including ulcerative colitis, ischemic colitis, and aspiration |
| Food/Dietary | Avoid solid food and dairy products during bowel preparation. Only clear liquids (e.g., water, clear broth, apple juice, black coffee/tea) are permitted. Do not consume alcohol. |
| Clinical Pearls | Requires adequate hydration to prevent renal injury; rare cases of osmotic demyelination syndrome reported with rapid correction of hyponatremia; contra indicated in GI obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon. |
| Patient Advice | Do not take within 1 hour of other oral medications as absorption may be reduced. · Complete the entire course: split-dose regimen or single dose per prescribing information. · Expect watery stools; stay near a restroom after starting the dose. · Consume only clear liquids during preparation – no red or purple dyes. · Seek medical attention for severe abdominal pain, vomiting, or inability to tolerate the solution. |
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