Indication for MOVIPREP
MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.
Important Safety Information about MOVIPREP
Do not take MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium
ascorbate and ascorbic acid for oral solution) if you have a gastrointestinal (GI) obstruction (a blockage
in your bowel), bowel perforation (an opening in the wall of your stomach or intestine), gastric retention
(problems with food and fluid emptying from your stomach), ileus (bowel muscle unable to move
stomach contents), toxic colitis (damage to the thickness of the intestinal wall) or toxic megacolon (an
extremely dilated or distended colon with fever and/or abdominal pain at times), or if you have a known
allergy to MOVIPREP or any of its components.
It is important to drink sufficient liquids before, during, and after the use of MOVIPREP. Liquid and
blood salt changes can lead to serious side effects including abnormal heartbeats, seizures, and kidney
problems. Talk to your doctor before taking MOVIPREP if you take any medications that increase the risk
of blood salt abnormalities or if you have known or suspected low blood salt (sodium) level
If you have kidney problems or if you take medication that affects kidney function, talk to your doctor
before taking MOVIPREP.
If you have suspected bowel blockage or a suspected opening in the wall of your stomach or intestine,
talk to your doctor before taking MOVIPREP.
Talk to your doctor before taking MOVIPREP if you have problems swallowing, if you have gastric reflux,
or if you are predisposed to aspiration.
If you have a condition that destroys red blood cells called glucose-6-phosphate dehydrogenase (G6PD)
deficiency, talk to your doctor before taking MOVIPREP.
Please be advised that MOVIPREP contains 131 mg of phenylalanine per treatment.
If you are pregnant or planning to become pregnant, talk to your doctor before taking MOVIPREP.
In clinical studies with MOVIPREP, the most common side effects for split dosing were malaise (feeling
uneasy), nausea, stomach (abdominal) pain, vomiting, and upper stomach pain. The most common side
effects for evening only dosing were stomach swelling (abdominal distension), anal discomfort, thirst,
nausea, stomach (abdominal) pain, sleep disorder, rigors (body shakes), hunger, malaise (feeling
uneasy), vomiting, and dizziness.
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
Please see complete Prescribing Information for MOVIPREP.