GOLYTELY
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GOLYTELY (GOLYTELY).
Polyethylene glycol 3350 is an osmotic laxative that induces diarrhea by retaining water in the bowel lumen through osmotic activity. Electrolytes (sodium sulfate, potassium chloride, sodium bicarbonate) prevent significant electrolyte absorption or loss.
| Metabolism | Not metabolized; excreted unchanged in feces. |
| Excretion | Primarily fecal elimination of unabsorbed polyethylene glycol 3350. Minimal systemic absorption (<0.06%), less than 0.06% recovered in urine as intact PEG 3350; electrocytes and sulfate (from sodium sulfate) are renally excreted. |
| Half-life | Not applicable (PEG 3350 is not significantly absorbed; effective half-life in GI tract is approximately 2-4 hours for colonic clearance). |
| Protein binding | Not applicable (PEG 3350 is a large polymer with negligible systemic absorption; no protein binding data). |
| Volume of Distribution | Not applicable (PEG 3350 remains largely in GI tract; Vd not clinically relevant due to minimal absorption). |
| Bioavailability | Oral: <0.06% (systemic bioavailability of PEG 3350 is negligible). |
| Onset of Action | Oral: 1-2 hours (first bowel movement); full colonic evacuation within 3-4 hours. |
| Duration of Action | Duration of bowel cleansing effect: 3-4 hours for complete evacuation; residual effects (e.g., loose stools) may persist up to 6 hours. Clinical use: single-dose preparation for colonoscopy. |
240 mL (oral) every 10 minutes until 4 L consumed or rectal effluent is clear; typically 4 L total over 3-4 hours.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment; use with caution in severe renal disease due to potential fluid/electrolyte imbalance. |
| Liver impairment | No dose adjustment recommended for hepatic impairment; use caution in severe hepatic disease. |
| Pediatric use | 25-40 mL/kg/hour (oral) until clear rectal effluent; maximum 4 L; not recommended for children <6 months. |
| Geriatric use | Use with caution; monitor fluid and electrolyte status closely due to increased risk of aspiration, dehydration, and renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GOLYTELY (GOLYTELY).
| Breastfeeding | Not absorbed systemically, thus no excretion into breast milk expected. Considered compatible with breastfeeding. M/P ratio not applicable due to lack of absorption. |
| Teratogenic Risk | Golytely (polyethylene glycol 3350) is not systemically absorbed, thus no direct fetal exposure. Based on lack of absorption and animal studies, risk is minimal. No adequate human data, but FDA category C. Use during pregnancy only if clearly needed. |
| Fetal Monitoring |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
["Gastrointestinal obstruction","Gastric retention","Bowel perforation","Toxic colitis","Toxic megacolon","Hypersensitivity to any component"]
| Precautions | ["Risk of aspiration if given to patients with impaired gag reflex or unconsciousness","May cause electrolyte disturbances, especially in patients with renal impairment","Use with caution in patients with severe ulcerative colitis or toxic megacolon","Risk of arrhythmias if electrolyte imbalance occurs"] |
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| No specific fetal monitoring required. Monitor maternal fluid and electrolyte status during prolonged use, especially in patients with comorbidities. |
| Fertility Effects | No known effects on fertility based on mechanism and lack of systemic absorption. |