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Plenvu Approval History

Reviewed on May 7, 2018 by J.Stewart B.Pharm.

  • FDA approved: Yes (First approved May 4th, 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 History and FDA Approval Process for Plenvu

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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