PLENVU
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PLENVU (PLENVU).
PLENVU is an osmotic laxative that induces bowel cleansing by causing water retention in the colon, leading to increased intraluminal pressure and stimulation of peristalsis. Its components (polyethylene glycol 3350, sodium ascorbate, ascorbic acid, sodium sulfate) act synergistically to produce a cathartic effect.
| Metabolism | Polyethylene glycol 3350 is minimally absorbed and eliminated unchanged in feces. Ascorbic acid and sodium ascorbate are absorbed and metabolized via normal pathways (e.g., oxidation, conjugation). Sodium sulfate is absorbed and excreted primarily in urine. |
| Excretion | Primarily fecal (90-95%) as unabsorbed drug; renal excretion is negligible (<1%). |
| Half-life | Not applicable (non-absorbed agent); systemic absorption is minimal, so no terminal half-life is defined. |
| Protein binding | <5% bound to plasma proteins (due to minimal absorption). |
| Volume of Distribution | Not applicable (confined to GI tract; systemic Vd not measurable). |
| Bioavailability | Oral: <0.1% systemically available due to lack of absorption. |
| Onset of Action | Oral: 1-3 hours to first bowel movement; full effect in 2-6 hours. |
| Duration of Action | 6-8 hours for bowel cleansing; effect resolves after complete evacuation. |
2 sachets (each containing ascorbic acid 4.7g, macrogol 3350 52.5g, sodium ascorbate 5.9g, sodium sulfate 3.75g) dissolved in water to a total volume of 500mL, administered orally as a split-dose regimen: first dose (2 sachets in 500mL water) at 6-9 pm on the day before colonoscopy, followed by additional 500mL of clear fluids; second dose (2 sachets in 500mL water) on the morning of colonoscopy, completed at least 2 hours before the procedure, followed by additional 500mL of clear fluids.
| Dosage form | FOR SOLUTION |
| Renal impairment | Contraindicated in patients with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² due to risk of acute phosphate nephropathy. No dose adjustment recommended for eGFR ≥ 30 mL/min/1.73 m². |
| Liver impairment | No specific dosage adjustment based on Child-Pugh classification is provided by the manufacturer. Use with caution in patients with severe hepatic impairment due to potential electrolyte disturbances. |
| Pediatric use | Not approved for use in pediatric patients (age < 18 years). Safety and efficacy not established. |
| Geriatric use | No specific dose adjustment required for elderly patients, but caution is advised due to increased risk of dehydration, electrolyte abnormalities, and renal impairment. Ensure adequate hydration and monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PLENVU (PLENVU).
| Breastfeeding | It is unknown whether PLENVU or its components are excreted in human breast milk. Polyethylene glycol is poorly absorbed systemically after oral administration, suggesting minimal transfer into breast milk. However, because many drugs are excreted in human milk, caution should be exercised when PLENVU is administered to a nursing woman. The M/P ratio has not been established for this combination product. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for PLENVU. |
| Teratogenic Risk | PLENVU (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, and macrogol) is classified as FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. In animal studies, no evidence of teratogenicity was observed at doses up to 2 times the maximum recommended human dose. However, the osmotic laxative effect may cause fluid and electrolyte shifts, potentially affecting fetal perfusion. Use during pregnancy should be reserved for cases where bowel cleansing is essential and benefits outweigh risks, particularly in the first trimester due to theoretical concerns of dehydration or electrolyte imbalance. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Gastrointestinal obstruction or ileus.","Perforation of the gastrointestinal tract.","Gastric retention or gastroparesis.","Toxic colitis or toxic megacolon.","Known hypersensitivity to any component of PLENVU."]
| Precautions | ["Serious fluid and electrolyte abnormalities (e.g., hyponatremia, hypokalemia, seizures).","Cardiac arrhythmias in patients with electrolyte imbalances or prolonged QT interval.","Renal impairment: Risk of acute tubular necrosis and nephrocalcinosis.","Mucosal ulceration or colitis (rare).","Sulfate absorption may cause metabolic acidosis in susceptible patients."] |
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| Fetal Monitoring | Monitor maternal hydration status, serum electrolytes (sodium, potassium, calcium, magnesium, phosphate), and renal function before and during bowel preparation. Assess for signs of dehydration or electrolyte disturbances, including dizziness, syncope, or altered mental status. Fetal heart rate monitoring should be considered in late pregnancy if maternal fluid shifts occur. Ensure adequate fluid intake throughout the preparation. |
| Fertility Effects | Data are not available: No human or animal studies have been conducted to evaluate the effects of PLENVU on fertility. The components are not expected to impact fertility adversely, but theoretical concerns regarding electrolyte imbalance or dehydration could indirectly affect reproductive function. No specific recommendations can be made. |