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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