PLENVU Dosage & Rx Info | Uses, Side Effects

Plenvu Generic Name & Formulations

Legal Class

General Description

Polyethylene glycol 3350 140g, sodium ascorbate 48.11g, sodium sulfate 9g, ascorbic acid 7.54g, sodium chloride 5.2g, potassium chloride 2.2g; per 32 fluid ounces; pwd for reconstitution; contains phenylalanine 491mg/treatment; mango- or fruit punch-flavor.

Pharmacological Class

Osmotic laxative.

How Supplied

Carton—1 (disposable container w. 3 pouches)

Manufacturer

Bausch Health Companies Inc.

Generic Availability

Mechanism of Action

The primary mode of action is osmotic action of the components of Plenvu (PEG 3350 plus sodium sulfate components in Dose 1, and sodium ascorbate and ascorbic acid plus PEG 3350 components in Dose 2) which induce the laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

Plenvu Indications

Indications

Bowel cleansing before colonoscopy.

Plenvu Dosage and Administration

Adult

No solid food from start of prep. Two-day regimen: start the evening before colonoscopy, drink 480mL over 30mins, follow with 480mL of clear liquids over next 30mins; in the AM, drink 480mL over 30mins, then drink 480mL of clear liquids over next 30mins. Consume additional water or clear liquids up to 2hrs before colonoscopy. One-day regimen: start the morning of colonoscopy, drink 480mL over 30mins, follow with 480mL of clear liquids over next 30mins. At minimum of 2hrs after first dose, drink 480mL over 30mins, follow with 480mL of clear liquids over next 30mins. Consume additional water or clear liquids up to 2hrs before colonoscopy.

Children

Not established.

Plenvu Contraindications

Contraindications

GI obstruction. Bowel perforation. Gastric retention. Ileus. Toxic megacolon.

Plenvu Boxed Warnings

Not Applicable

Plenvu Warnings/Precautions

Warnings/Precautions

Correct fluid/electrolyte abnormalities before use. History of prolonged QT, uncontrolled arrhythmias, recent MI, unstable angina, CHF, cardiomyopathy, or electrolyte imbalance: increased risk of arrhythmias; consider pre-dose and post-colonoscopy ECGs. History or risk of seizures. Renal impairment; perform baseline and post-colonoscopy electrolytes, creatinine, BUN. Inflammatory bowel disease. Rule out suspected GI obstruction/perforation before administering. Severe ulcerative colitis. Impaired gag reflex or other swallowing abnormalities; risk for regurgitation or aspiration. G6PD deficiency. Phenylketonuria. Maintain adequate hydration. Elderly. Pregnancy. Nursing mothers.

Plenvu Pharmacokinetics

Elimination

Fecal. Half-life: 4.1 hours (PEG 3350), 7.2 hours (ascorbate), 10.5 hours (sulfate).

Plenvu Interactions

Interactions

Avoid reconstitution of prep with starch-based thickeners. Caution with drugs that increase risk of fluid/electrolyte abnormalities, renal impairment, seizures, arrhythmias, or QT prolongation. Drugs that may lower the seizure threshold (eg, tricyclic antidepressants), alcohol or benzodiazepine withdrawal, known or suspected hyponatremia: may increase risk of seizures. Concomitant diuretics, ACE inhibitors, ARBs, NSAIDs; may affect renal function. Concomitant stimulant laxatives: not recommended; may increase risk of mucosal ulceration, ischemic colitis. May reduce the absorption of other concomitant oral drugs. Separate dosing of oral drugs by at least 1hr before starting Plenvu.

Plenvu Adverse Reactions

Adverse Reactions

Nausea, vomiting, dehydration, abdominal pain/discomfort, fatigue, headache; hypersensitivity reactions; rare: arrhythmias, tonic-clonic seizures.

Plenvu Clinical Trials

See Literature

Plenvu Note