PLENVU® (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution) is a prescription medication used by adults to clean the colon before a colonoscopy.
IMPORTANT SAFETY INFORMATION
- Do not take PLENVU if you have a blockage in your intestine (bowel obstruction), an opening in the wall of your stomach or intestine (bowel perforation), problems with food or fluid emptying from your stomach (gastric retention), a problem with food moving too slowly through your intestines (ileus), a very dilated large intestine, or an allergy to any of the ingredients in PLENVU.
- It is important to drink sufficient clear liquids before, during, and after the use of PLENVU. Be sure to consume additional clear liquids after the first dose and second dose of PLENVU. Stop drinking liquids 2 hours prior to colonoscopy.
- Before you take PLENVU, talk to your doctor if you:
- Have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
- Have heart problems or take medication that affects your heart. Your doctor may consider obtaining an electrocardiogram (ECG) test if you are at an increased risk for heart rhythm abnormalities.
- Have a history of seizures or take antiseizure medication.
- Have kidney problems or take medication that affects kidney function. Your doctor may want to perform blood testing before and after your colonoscopy.
- Have a history of stomach or bowel problems, such as ulcerative colitis, a bowel blockage, or a suspected opening in the wall of your stomach or intestine.
- Have problems swallowing, heartburn (gastric reflux), or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
- Have a condition that destroys red blood cells, called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Are withdrawing from drinking alcohol.
- Have phenylketonuria (PKU). PLENVU contains aspartame equivalent to 491 mg of phenylalanine per treatment.
- Are pregnant or plan to become pregnant.
- Are breastfeeding or plan to breastfeed.
- PLENVU may affect how other medications work. Tell your doctor about all other medications (including prescription and nonprescription medicines, vitamins, and herbal supplements) you take before you take PLENVU. Do not take oral medications within 1 hour before or after starting each dose of PLENVU.
- Symptoms of serious allergic reactions may include skin rash, itching, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat, and kidney problems.
- In clinical studies with PLENVU, the most common side effects in patients taking PLENVU were nausea, vomiting, dehydration, and abdominal pain/discomfort.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
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