PEG-LYTE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PEG-LYTE (PEG-LYTE).
PEG-LYTE is an osmotic laxative that induces diarrhea by retaining water in the colon through the non-absorbable polyethylene glycol (PEG) and electrolytes, which prevent dehydration and electrolyte imbalance during bowel cleansing.
| Metabolism | Polyethylene glycol (PEG) is not metabolized and is excreted unchanged in feces. The electrolytes (sodium, potassium, bicarbonate, chloride) are absorbed and metabolized according to normal physiological pathways. |
| Excretion | Primarily fecal (98-99%) as unchanged polyethylene glycol (PEG) 3350; negligible renal excretion (<0.2%). Electrolytes (sodium, potassium, bicarbonate) are partially absorbed and excreted renally. |
| Half-life | Not applicable; PEG-3350 is minimally absorbed (<0.06%), thus systemic half-life is not clinically relevant. Local gut transit time ~1-2 hours. |
| Protein binding | Negligible (<1%); PEG-3350 does not bind to plasma proteins. |
| Volume of Distribution | Not applicable due to negligible absorption. For absorbed fraction, estimated Vd ~0.3 L/kg (based on PEG distribution to extracellular fluid). |
| Bioavailability | Oral: <0.06% (systemic absorption of PEG-3350 is minimal). Electrolytes are absorbed variably. |
| Onset of Action | Oral: 30-60 minutes to first bowel movement; maximal effect at 2-3 hours. |
| Duration of Action | Effects last 3-4 hours post ingestion; complete colonic evacuation typically within 4-6 hours. |
4 liters orally as a single dose or in divided doses for colonoscopy preparation.
| Dosage form | FOR SUSPENSION |
| Renal impairment | Contraindicated in patients with GFR < 30 mL/min/1.73 m² due to risk of electrolyte abnormalities and fluid overload. For GFR 30-60 mL/min/1.73 m², use with caution and monitor electrolytes. |
| Liver impairment | No specific dose adjustment required for Child-Pugh A or B. For Child-Pugh C, use with caution due to ascites risk. |
| Pediatric use | Weight-based dosing: 25-40 mL/kg per dose, up to a maximum of 4 liters total, for colonoscopy preparation. Dose should be adjusted based on clinical response and tolerability. |
| Geriatric use | Initiate at lower doses (e.g., 2 liters total) with slower administration, monitor for dehydration and electrolyte imbalances, and consider split-dose regimens. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PEG-LYTE (PEG-LYTE).
| Breastfeeding | PEG-LYTE (polyethylene glycol 3350 with electrolytes) is minimally absorbed systemically and not expected to be excreted into breast milk. M/P ratio not applicable due to negligible plasma levels. |
| Teratogenic Risk | No known teratogenic risk. Insufficient data for first trimester; minimal systemic absorption makes fetal exposure unlikely. No evidence of fetal harm during second and third trimesters. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus, hypersensitivity to any component of the product.
| Precautions | Risk of aspiration and regurgitation (especially in patients with impaired gag reflex), serious fluid and electrolyte disturbances (especially in patients with renal impairment, electrolyte abnormalities, or those taking diuretics or other medications that affect electrolytes), risk of cardiac arrhythmias due to electrolyte shifts, potential for mucosal ulcerations or ischemic colitis, and use with caution in patients with severe ulcerative colitis or toxic megacolon. |
Loading safety data…
| No specific monitoring required. Observe for electrolyte imbalance if large volumes used; monitor serum electrolytes if administered over prolonged periods or in at-risk patients. |
| Fertility Effects | No known effects on fertility. No studies available, but minimal systemic absorption makes significant impact unlikely. |