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Plenvu FDA Approval History

Last updated by Judith Stewart, BPharm on May 7, 2018.

FDA Approved: Yes (First approved May 4, 2018)
Brand name: Plenvu
Generic name: polyethylene glycol 3350 with electrolytes
Dosage form: for Oral Solution
Company: Salix Pharmaceuticals, Inc.
Treatment for: Bowel Preparation

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride) is a lower-volume, polyethylene glycol based osmotic laxative indicated for cleansing of the colon (bowel preparation) prior to colonoscopy.

Preparation and Administration

  • Two doses of Plenvu are required for a complete preparation for colonoscopy, using a "Two-Day" or "One-Day" dosing regimen.
    • Two-Day Dosing Regimen: Dose 1 is taken the evening before the colonoscopy (approximately 4 pm to 8 pm) and Dose 2 is taken the next morning (approximately 12 hours after the start of Dose 1).
    • One-Day Dosing Regimen: Dose 1 is taken 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.
  • Plenvu must be reconstituted in water prior to ingestion and additional clear liquids must be consumed after each dose. Drink only clear liquids before, during, and after taking Plenvu, until 2 hours before the colonoscopy to help prevent dehydration.
  • Do not take oral medications within one hour of starting each dose.
  • Do not take other laxatives while you are taking Plenvu.
  • Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material while you are taking Plenvu.

Warnings and Precautions

Plenvu and other bowel preparations can cause serious side effects, including serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. Consume additional water or clear liquids to prevent dehydration. Contact your healthcare provider if you develop significant vomiting or signs of dehydration.

Plenvu Side Effects

Common side effects include nausea, vomiting, dehydration and abdominal pain/discomfort.

Development timeline for Plenvu

May  7, 2018Approval Salix Receives FDA Approval for Plenvu, Next Generation 1-Liter Bowel Cleansing Preparation for Colonoscopies
Feb  9, 2018Salix Provides Update on FDA Submission for Plenvu
Jun 28, 2017Salix Announces Filing Acceptance for Plenvu Next Generation Bowel Cleansing Preparation for Colonoscopies

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.