COLYTE WITH FLAVOR PACKS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COLYTE WITH FLAVOR PACKS (COLYTE WITH FLAVOR PACKS).
Colyte is an isotonic solution containing polyethylene glycol 3350 and electrolytes. It acts as an osmotic laxative by retaining water in the colon through non-absorbable polyethylene glycol, resulting in bowel evacuation. The electrolytes prevent significant fluid and electrolyte shifts.
| Metabolism | Polyethylene glycol 3350 is minimally absorbed and not metabolized; it is excreted unchanged in feces. Electrolytes are absorbed and metabolized normally. |
| Excretion | Primarily fecal (100%) as non-absorbed oral solution; negligible renal or biliary elimination. |
| Half-life | Not applicable (non-absorbed; no systemic absorption, thus no elimination half-life in plasma). |
| Protein binding | Not applicable (non-absorbed; no systemic exposure). |
| Volume of Distribution | Not applicable (non-absorbed; no systemic distribution). |
| Bioavailability | Oral: negligible systemic bioavailability (<0.1%) due to minimal absorption of polyethylene glycol and electrolytes. |
| Onset of Action | Oral: catharsis begins 30–60 minutes after ingestion, with full effect within 3 hours. |
| Duration of Action | Oral: catharsis persists for 4–6 hours after the last dose; clinical effect lasts until bowel is cleared (typically 3–4 hours total procedure time). |
Adults: 4 liters of reconstituted solution administered orally or via nasogastric tube at a rate of 240 mL every 10 minutes, given as a single dose or in divided doses for colonoscopy preparation.
| Dosage form | FOR SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment; however, use with caution in patients with severe renal impairment (GFR <30 mL/min) due to risk of fluid and electrolyte abnormalities. |
| Liver impairment | No specific dose adjustment for hepatic impairment; use standard dosing with caution in severe liver disease due to potential fluid shifts. |
| Pediatric use | Pediatric patients: 25-40 mL/kg/hour until rectal effluent is clear; maximum 4 liters total. Safety and efficacy not established for children under 6 months. |
| Geriatric use | Elderly: Consider reduced volume (e.g., 2-3 liters) and slower administration rate (e.g., 240 mL every 20 minutes) to mitigate risk of aspiration and electrolyte imbalance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COLYTE WITH FLAVOR PACKS (COLYTE WITH FLAVOR PACKS).
| Breastfeeding | PEG is not absorbed systemically, thus minimal excretion into breast milk. M/P ratio not applicable/unknown. Considered compatible with breastfeeding as a bowel preparation, but caution with large volumes may alter maternal fluid/electrolyte status, indirectly affecting milk production or composition. Use only if clearly needed. |
| Teratogenic Risk | Pregnancy Category C. No adequate well-controlled studies in pregnant women. Polyethylene glycol (PEG) is not systemically absorbed; minimal fetal exposure expected. Electrolyte shifts could theoretically affect fetal fluid balance, but no known teratogenicity. First trimester: low risk based on lack of systemic absorption. Second/third trimester: theoretical risk of maternal electrolyte imbalance affecting fetal homeostasis, though no specific fetal adverse effects reported. |
■ FDA Black Box Warning
WARNING: SERIOUS FLUID AND ELECTROLYTE ABNORMALITIES, SEIZURES, AND CARDIAC ARRHYTHMIAS. Use with caution in patients at risk for these conditions. Monitor fluid and electrolyte status.
| Serious Effects |
["Gastrointestinal obstruction or ileus","Gastric retention or perforation","Bowel perforation","Toxic colitis or toxic megacolon","Hypersensitivity to any component"]
| Precautions | ["Risk of aspiration, especially in patients with impaired gag reflex or reduced level of consciousness","Fluid and electrolyte disturbances (e.g., hyponatremia, hypokalemia) may occur; monitor in patients with renal or hepatic impairment, heart failure, or those taking diuretics or other drugs affecting electrolytes","Seizures and cardiac arrhythmias have been reported, often in patients with electrolyte imbalances or taking medications that lower seizure threshold","Mucosal ulcerations may occur; avoid use in patients with active inflammatory bowel disease or toxic megacolon","Arrhythmias (e.g., atrial fibrillation, QT prolongation) have been reported","Upper GI bleeding or obstruction; contraindicated in gastric retention or obstruction"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal electrolytes (sodium, potassium, chloride, bicarbonate, calcium), renal function, and volume status before, during, and after administration. Assess for nausea, vomiting, abdominal distension, and signs of dehydration or fluid overload. Fetal monitoring as clinically indicated (e.g., non-stress test if maternal complications arise). |
| Fertility Effects | No known effect on fertility. PEG and electrolytes are not systemically absorbed, so unlikely to impair fertility in either gender. |