CLENZ-LYTE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLENZ-LYTE (CLENZ-LYTE).
Colon lavage solution that osmotically induces diarrhea to cleanse the colon.
| Metabolism | Not metabolized; minimally absorbed. |
| Excretion | Primarily fecal (approximately 95%) as unabsorbed polyethylene glycol; negligible renal excretion (<5%) as intact polymer. |
| Half-life | Not applicable; systemic absorption is negligible (plasma levels below detection limits). Clinical effect is localized to gastrointestinal tract. |
| Protein binding | Negligible (<1%) as polyethylene glycol is not bound to plasma proteins. |
| Volume of Distribution | Not applicable; drug remains largely in the gastrointestinal lumen; negligible systemic distribution. |
| Bioavailability | Oral: <0.2% (minimal systemic absorption); rectal: negligible (local action only). |
| Onset of Action | Oral: 1-2 hours (initial bowel movement). Rectal: 30 minutes to 1 hour (evacuation). |
| Duration of Action | Oral: 2-4 hours (bowel preparation effect persisted until complete evacuation). Rectal: 1-2 hours (evacuation time). |
Oral: 4 L (or 240 mL every 10 minutes) administered the evening before colonoscopy; alternatively, 2 L (or 240 mL every 10 minutes) plus 2 L of clear liquids given in split doses (first 1-2 L evening before, remaining in morning of procedure).
| Dosage form | FOR SOLUTION |
| Renal impairment | GFR < 30 mL/min: Not recommended due to risk of electrolyte abnormalities. GFR 30-60 mL/min: Use with caution, monitor electrolytes. |
| Liver impairment | Child-Pugh Class A, B, C: No specific dose adjustment recommended; use caution in severe hepatic impairment due to risk of fluid and electrolyte shifts. |
| Pediatric use | Weight-based: Not FDA-approved for pediatric use. For bowel preparation in children: 25-40 mL/kg/dose orally, maximum 4 L total, administered over 3-4 hours. |
| Geriatric use | No specific dose adjustment; use with caution due to increased risk of electrolyte disturbances, dehydration, and renal impairment. Ensure adequate hydration and monitor electrolytes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLENZ-LYTE (CLENZ-LYTE).
| Breastfeeding | Polyethylene glycol 3350 is minimally absorbed systemically (<0.06% absorbed), and thus levels in breast milk are expected to be negligible. No M/P ratio has been determined. It is considered compatible with breastfeeding; however, caution is advised due to possible osmotic diarrhea in the infant if maternal doses are high. Use during breastfeeding only if clearly needed. |
| Teratogenic Risk | CLENZ-LYTE (polyethylene glycol 3350, electrolytes) is a bowel preparation agent. Animal studies have not been conducted. There is no evidence of fetal harm from limited human data; however, teratogenic risk cannot be excluded. First trimester: unknown risk due to lack of studies; avoid unless necessary. Second/third trimester: no known teratogenicity, but use only if clearly indicated due to risk of maternal dehydration and electrolyte imbalance, which may affect placental perfusion. |
■ FDA Black Box Warning
None
| Serious Effects |
["Gastric outlet obstruction","Ileus or bowel obstruction","Toxic colitis or megacolon","Perforated bowel","Hypersensitivity to any component"]
| Precautions | ["Risk of aspiration in patients with impaired gag reflex","Electrolyte disturbances (e.g., hyponatremia, hypokalemia)","Arrhythmias in patients with electrolyte abnormalities","Use caution in patients with renal impairment or congestive heart failure"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes (sodium, potassium, chloride, bicarbonate) before and during therapy, especially if prolonged or repeated use. Assess hydration status and renal function. In pregnancy, monitor for signs of uterine irritability or contractions due to volume shifts. Fetal monitoring as per routine prenatal care; consider nonstress test if maternal dehydration occurs. |
| Fertility Effects | No data on fertility effects in humans. Animal studies have not revealed impaired fertility. Polyethylene glycol 3350 is not expected to interfere with reproductive function due to minimal systemic absorption. |