COLYTE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COLYTE (COLYTE).
Colyte is a polyethylene glycol (PEG)-based osmotic laxative that induces diarrhea by retaining water in the gastrointestinal tract via osmotic forces, thereby cleansing the colon.
| Metabolism | Polyethylene glycol is not significantly metabolized and is excreted largely unchanged in feces. |
| Excretion | COLYTE (polyethylene glycol 3350 and electrolytes) is minimally absorbed; <0.1% of the dose is excreted renally. The majority is eliminated unchanged in feces via the gastrointestinal tract, with fecal excretion accounting for >99%. |
| Half-life | Not applicable; systemic absorption is negligible (<0.06%), so a terminal elimination half-life is clinically irrelevant. The gastrointestinal transit time for the solution is approximately 1-3 hours. |
| Protein binding | Not applicable; negligible systemic absorption, so protein binding is clinically irrelevant. |
| Volume of Distribution | Not applicable; negligible systemic absorption, so volume of distribution is clinically irrelevant. |
| Bioavailability | Oral: <0.1% (systemic bioavailability is negligible due to minimal absorption of polyethylene glycol). |
| Onset of Action | Oral: 1-2 hours (onset of bowel evacuation, with maximal effect typically within 1-3 hours). |
| Duration of Action | Oral: Duration of bowel cleansing effect lasts until the colon is evacuated, usually ceasing within 2-6 hours after the last dose. The drug itself is not systemically active. |
4 L oral solution administered as a single dose at a rate of 240 mL every 10 minutes until complete.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment; use with caution in severe renal insufficiency (CrCl <30 mL/min) due to potential electrolyte imbalance. |
| Liver impairment | No specific dose adjustments for hepatic impairment; use with caution in severe hepatic disease. |
| Pediatric use | Pediatric patients (≥6 months): 25-40 mL/kg/hour orally or via nasogastric tube until rectal effluent is clear; maximum 4 L. |
| Geriatric use | No specific dose adjustment; monitor for dehydration and electrolyte disturbances due to reduced renal reserve. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COLYTE (COLYTE).
| Breastfeeding | Not known if excreted in human milk. M/P ratio not determined. Caution advised due to potential for diarrhea in nursing infant. Use only if clearly needed. |
| Teratogenic Risk | Category C. No adequate and well-controlled studies in pregnant women. Animal studies have not been conducted. Should be used during pregnancy only if clearly needed. Potential for fetal harm due to maternal dehydration or electrolyte imbalance. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Gastrointestinal obstruction, bowel perforation, toxic megacolon, gastric retention, ileus, known hypersensitivity to any component of the product.
| Precautions | Risk of electrolyte disturbances (especially in patients with renal impairment or those taking medications affecting electrolytes), aspiration risk (use with caution in patients with impaired gag reflex or at risk of regurgitation), serious fluid and electrolyte abnormalities, cardiac arrhythmias, seizures, and serious adverse reactions including ischemic colitis and ulcerative colitis. Use with caution in patients with severe ulcerative colitis, toxic megacolon, or gastrointestinal obstruction. |
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| Monitor maternal serum electrolytes (sodium, potassium, chloride, bicarbonate) and renal function during prolonged use. Assess for signs of dehydration, nausea, vomiting, or abdominal distention. Fetal monitoring not specifically required. |
| Fertility Effects | No known effects on fertility. Data not available. |