COLOVAGE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for COLOVAGE (COLOVAGE).
COLOVAGE is a bowel cleansing preparation containing polyethylene glycol 3350 and electrolytes. It acts as an osmotic laxative, causing fluid retention in the colon to stimulate bowel evacuation.
| Metabolism | Polyethylene glycol 3350 is not absorbed systemically; no hepatic metabolism. |
| Excretion | Primarily fecal as unabsorbed drug; negligible renal excretion (<5%) |
| Half-life | Not applicable (non-absorbed, gut lavage); systemic absorption minimal |
| Protein binding | Not applicable (minimal systemic absorption) |
| Volume of Distribution | Not applicable (limited to gastrointestinal tract) |
| Bioavailability | Oral: <0.3% systemically absorbed |
| Onset of Action | Oral: 30-60 minutes (bowel cleansing effect) |
| Duration of Action | Oral: Duration of use (until clear effluent; typically 2-4 hours) |
4 liters of PEG-3350 electrolyte solution orally as a single dose for colon cleansing prior to colonoscopy; alternatively, 2 liters with ascorbic acid regimen.
| Dosage form | FOR SUSPENSION |
| Renal impairment | Contraindicated in GFR <30 mL/min/1.73 m²; for GFR 30-60 mL/min/1.73 m², use with caution due to risk of electrolyte imbalance, no dose adjustment recommended. |
| Liver impairment | No specific Child-Pugh based adjustments; use with caution in severe hepatic impairment due to potential fluid and electrolyte disturbances. |
| Pediatric use | Not indicated for patients under 18 years of age; no established weight-based dosing. |
| Geriatric use | No specific dose adjustment, but monitor for electrolyte disturbances, dehydration, and aspiration risk; consider split-dose regimen or lower volume if tolerated. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for COLOVAGE (COLOVAGE).
| Breastfeeding | Due to lack of systemic absorption, excretion into breast milk is negligible. Colovage is considered compatible with breastfeeding. M/P ratio: not applicable. |
| Teratogenic Risk | Colovage (polyethylene glycol 3350) is not absorbed systemically; no teratogenic risk anticipated in any trimester. No fetal risks reported with oral use. |
| Fetal Monitoring | No specific fetal monitoring required. Monitor maternal electrolyte balance and hydration status during prolonged use in pregnancy. |
■ FDA Black Box Warning
Risk of fluid and electrolyte abnormalities (e.g., hyponatremia, seizures) in patients with impaired renal function, dehydration, or those taking medications affecting electrolytes.
| Serious Effects |
Gastrointestinal obstruction, ileus, gastric retention, bowel perforation, toxic colitis or megacolon, hypersensitivity to any component.
| Precautions | Monitor for fluid and electrolyte disturbances, especially in elderly, debilitated, or renal impaired patients. Use with caution in patients with gastrointestinal obstruction, ileus, or severe colitis. |
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| Fertility Effects | No known effects on fertility. No reproductive toxicity studies indicate impairment. |