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
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