INDICATION
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®.
- PLENVU® and other bowel preparations can cause serious side effects including loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause abnormal heartbeats that may result in death, seizures (even if you have never had a seizure), or kidney problems. Your chance of having fluid loss and changes in body salts with PLENVU® is higher if you have heart problems, kidney problems, or take water pills, high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS).
- Your healthcare provider may do blood tests after you take PLENVU® to check your blood for changes. Tell your healthcare provider right away if you have any symptoms of too much fluid loss (dehydration) including vomiting, dizziness, heart problems, kidney problems, seizures, dry mouth, urinating less often than normal; headache, or feel faint, weak, or lightheaded, especially when you stand up.
- PLENVU® can cause ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.
- PLENVU® can cause serious allergic reactions that may include skin rash, itching, raised red patches on your skin (hives); swelling of the face, lips, tongue, and throat; and kidney problems.
- The most common side effects in patients taking PLENVU® were nausea, vomiting, dehydration, and stomach pain or discomfort.
- Tell your healthcare provider about all of your medical conditions and medicines you take, including prescription, nonprescription medicines, vitamins, and herbal supplements before you take PLENVU®.
These are not all the possible side effects of PLENVU®. Ask your healthcare provider for more information.
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
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: salixmc@dlss.com
Please click here for full Prescribing Information.