TRILYTE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRILYTE (TRILYTE).
TRILYTE (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid) is an osmotic laxative. The active components induce diarrhea by osmotically drawing water into the gastrointestinal lumen, thereby increasing stool volume and stimulating peristalsis. Sodium ascorbate and ascorbic acid enhance the osmotic effect.
| Metabolism | TRILYTE components are minimally absorbed and undergo negligible metabolism. Polyethylene glycol 3350 is excreted unchanged in feces. Ascorbic acid is metabolized via oxidation to dehydroascorbic acid, followed by further metabolism and renal excretion. |
| Excretion | Renal excretion of intact electrolyte ions; negligible drug excretion |
| Half-life | Not applicable; non-absorbed, acts locally in GI tract |
| Protein binding | Not applicable; non-absorbed |
| Volume of Distribution | Not applicable; non-absorbed |
| Bioavailability | Not applicable; not absorbed from GI tract |
| Onset of Action | Oral: 30-60 minutes for bowel evacuation |
| Duration of Action | Duration of bowel evacuation: 2-4 hours; complete clearance usually within 4-6 hours |
Adults: 1 liter (L) orally every 10-15 minutes until 4 L total consumed; complete ingestion within 4 hours.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dosage adjustment required for renal impairment; however, use with caution in severe renal impairment (CrCl <30 mL/min) due to risk of electrolyte disturbances. |
| Liver impairment | No dosage adjustment required for hepatic impairment; no specific Child-Pugh based modifications. |
| Pediatric use | Children 6 months to 12 years: 20 mL/kg orally per hour (maximum 1 L/hour) until rectal effluent clear; typical total dose 4 L. |
| Geriatric use | Use with caution; reduce rate of administration (e.g., 1 L over 2-3 hours) and monitor for electrolyte and fluid imbalances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRILYTE (TRILYTE).
| Breastfeeding | Polyethylene glycol 3350 is not significantly absorbed systemically, and its high molecular weight limits excretion into breast milk. Electrolytes are normal constituents. Therefore, risk to nursing infant is minimal. M/P ratio not established due to negligible absorption. Use caution: consider temporary interruption of breastfeeding during colon preparation and for 24 hours after procedure to avoid theoretical risk of infant diarrhea or electrolyte imbalance. |
| Teratogenic Risk | TRILYTE (polyethylene glycol 3350 with electrolytes) is a bowel cleansing solution. No teratogenic effects are expected due to minimal systemic absorption. Pregnancy Category C: insufficient human data; animal studies not available. Use only if clearly needed. Risk to fetus unlikely, but caution in first trimester due to potential maternal dehydration/electrolyte imbalance. |
■ FDA Black Box Warning
There is no FDA-issued black box warning for TRILYTE.
| Serious Effects |
["Gastrointestinal obstruction or ileus","Gastric retention","Bowel perforation","Toxic colitis or megacolon","Hypersensitivity to any component","Severe renal impairment (e.g., estimated glomerular filtration rate < 30 mL/min)"]
| Precautions | ["Risk of severe fluid and electrolyte disturbances (e.g., hyponatremia, hypokalemia, hypocalcemia) leading to arrhythmias or seizures, especially in patients with renal impairment or those taking diuretics","Risk of acute phosphate nephropathy (although TRILYTE does not contain phosphate, similar risks apply due to electrolyte shifts)","Mucosal ulcerations or ischemic colitis (rare)","Aspiration risk, particularly in patients with impaired gag reflex or swallowing disorders"] |
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| Fetal Monitoring | Monitor maternal vital signs, hydration status, and serum electrolytes (sodium, potassium, chloride, bicarbonate) before and during TRILYTE administration. Assess for signs of fluid overload or dehydration. Fetal monitoring as clinically indicated if maternal status compromised. In pregnancy, evaluate uterine activity if large fluid shifts occur. |
| Fertility Effects | No known effects on fertility. Systemic absorption is negligible; thus, no impact on reproductive function or fertility expected. No animal studies available, but clinical experience with polyethylene glycol suggests no impairment. |