GOLYTELY
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 3350 Da |
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 | Polyethylene glycol 3350 is minimally absorbed systemically and is considered safe during the first trimester. No known teratogenic effects in animal studies. Use only if clearly indicated. |
| 2nd trimester | Same as first trimester; minimal systemic absorption. Safe for bowel preparation when benefits outweigh risks. |
| 3rd trimester | Use with caution in late third trimester due to risk of electrolyte imbalance and uterine contractions from vigorous catharsis. Avoid if imminent delivery or cervical dilatation. |
Clinical note
Comprehensive clinical and safety monograph for GOLYTELY (GOLYTELY).
| Placental transfer | Negligible; polyethylene glycol 3350 has a high molecular weight and minimal systemic absorption (less than 0.06% absorbed). No significant placental transfer expected. |
| Breastfeeding | Polyethylene glycol 3350 is minimally absorbed and not expected to be excreted into breast milk in significant amounts. It is considered compatible with breastfeeding. Monitor infant for diarrhea or loose stools. |
| Lactation Rating | L1: Safe |
| 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 | 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. |
■ FDA Black Box Warning
No black box warning.
| Serious Effects |
Gastrointestinal obstructionGastric retentionBowel perforationToxic colitisToxic megacolonIleusHypersensitivity 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 |
| Food/Dietary | Avoid solid food for at least 2 hours before starting GOLYTELY. Only clear liquids are recommended during bowel preparation. Avoid dairy products, alcoholic beverages, and red or purple liquids. Do not consume any food or drink containing pulp or seeds. |
| Clinical Pearls | GOLYTELY (polyethylene glycol 3350 with electrolytes) is an osmotic laxative used for bowel cleansing prior to colonoscopy. Ensure adequate hydration before, during, and after administration. Administer in divided doses: half the evening before and half the morning of the procedure. Monitor for nausea, vomiting, or aspiration risk in elderly or debilitated patients. Discontinue if severe bloating or abdominal pain occurs. |
| Patient Advice | Drink the solution as directed. Do not add any other ingredients. · Do not eat solid food for at least 2 hours before starting the solution. · Stay near a bathroom as bowel movements will begin within 1-2 hours. · If you experience severe bloating, nausea, or vomiting, stop and rest, then resume if tolerated. · Complete all doses as prescribed for effective colon cleansing. · Common side effects include nausea, bloating, and cramping. |
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