These highlights do not include all the information needed to use PLENVU safely and effectively. See full prescribing information for PLENVU.
PLENVU � (polyethylene glycol 3350, sodium ascorbate, sodium sulfate,
ascorbic acid, sodium chloride and potassium chloride for oral solution)
Initial U.S. Approval: 2006
INDICATIONS AND USAGE
PLENVU is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration:
� Two doses of PLENVU are required for a complete preparation for colonoscopy, using a "Two-Day" or "One-Day" dosing regimen. (2.1)
� PLENVU must be reconstituted in water prior to ingestion. (2.1)
� Additional clear liquids must be consumed after each dose of PLENVU in both dosing regimens. (2.1, 5.1)
� Do not take oral medications within 1 hour of starting each dose. (2.1, 7.2)
Dosing Regimen:
� Two-Day: Dose 1 the evening before the colonoscopy (approximately 4 pm to 8 pm) and Dose 2 the next morning (approximately12 hours after the start of Dose 1). (2.1, 2.2)
� One-Day: Dose 1 the morning of the colonoscopy (approximately 3 am to 7 am) and Dose 2 a minimum of 2 hours after the start of Dose 1. (2.1, 2.3)
� For complete information on dosing, preparation and administration see full prescribing information. (2.1, 2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
For Oral Solution: First dose: one pouch labeled Dose 1; Second dose: two pouches labeled Dose 2 Pouch A and Dose 2 Pouch B.
� Dose 1 contains 100 grams of polyethylene glycol (PEG) 3350, NF; 9 grams of sodium sulfate, NF; 2 grams of sodium chloride, USP/NF; and 1 gram of potassium chloride, USP/NF. (3)
� Dose 2 Pouch A contains 40 grams of PEG 3350, NF; 3.2 grams of sodium chloride, USP/NF; and 1.2 grams of potassium chloride, USP/NF. (3)
� Dose 2 Pouch B contains 48.11 grams of sodium ascorbate, USP/NF; and 7.54 grams of ascorbic acid, USP/NF. (3)
CONTRAINDICATIONS
�
Gastrointestinal (GI) obstruction ( 4, 5.6)
�
Bowel perforation ( 4, 5.6)
�
Gastric retention ( 4)
�
Ileus ( 4)
�
Toxic megacolon ( 4)
�
Hypersensitivity to any ingredient in PLENVU ( 4, 5.10)
WARNINGS AND PRECAUTIONS
� Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. (5.1, 5.2, 7.1)
� Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. (5.2)
� Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. (5.3, 7.1)
� Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. (5.4, 7.1, 8.6)
� Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. (5.5)
� Suspected GI obstruction or perforation: Rule out diagnosis before administration. (4, 5.6)
� Patients at risk for aspiration: Observe during administration. (5.7)
� Glucose-6-phosphate dehydrogenase deficiency (G6PD): Use with caution. (5.8)
� Risks in patients with phenylketonuria: Contains phenylalanine. (5.9)
� Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.10)
ADVERSE REACTIONS
Most common adverse reactions (>2%) are nausea, vomiting, dehydration and abdominal pain/discomfort. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that increase risks due to fluid and electrolyte change. (7.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 5/2018
