MoviPrep (PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate)

Brand name: MoviPrep

Generic: PEG-3350, Sodium Sulfate, SodiumChloride, Potassium Chloride, Sodium Ascorbate

MoviPrep is a prescription medicine used by adults to clean the colon before a colonoscopy. MoviPrep cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if MoviPrep is safe and effective in children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the serious side effects of MoviPrep?

MoviPrep can cause serious side effects, including:

• Changes in certain blood tests. Your healthcare provider may do blood tests after you take MoviPrep to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • dizziness
  • heart problems
  • kidney problems
  • seizures
  • dry mouth
  • feel faint, weak or lightheaded especially when you stand up (orthostatic hypotension)
• 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.
• Serious allergic reactions. Symptoms of a serious allergic reaction may include:
  • skin rash
  • swelling of the face, lips, tongue and throat
  • raised red patches on your skin (hives)
  • itching
  • kidney problems

What are the common side effects of MoviPrep?

The most common side effects of MoviPrep include:

• anal discomfort
• thirst
• nausea
• stomach-area (abdomen pain or bloating)
• sleep problems
• chills
• hunger
• discomfort
• vomiting
• indigestion
• dizziness

These are not all the possible side effects of MoviPrep.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drugs That May Increase Risks Due To Fluid And Electrolyte Abnormalities

• Use caution when prescribing MoviPrep for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizures, arrhythmias, or QT prolongation in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate.

Potential For Reduced Drug Absorption

• MoviPrep can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of MoviPrep.

Stimulant Laxatives

• Concurrent use of stimulant laxatives and MoviPrep may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking MoviPrep.

• Take MoviPrep exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you to take the Two-Day Split-Dosing regimen option or the One-Day Evening Only Dosing regimen option.
• On the day before the procedure, you can have breakfast, followed by a light lunch (no solid foods), and dinner of clear soup with or without plain yogurt, or plain yogurt only. You must finish dinner at least 1 hour before the start of the first MoviPrep dose.
• Drink only clear liquids before, during, and after you take MoviPrep, until 2 hours before your colonoscopy to help prevent fluid loss (dehydration).
• Do not eat solid food while taking MoviPrep until after your colonoscopy.
• Do not eat or drink alcohol, milk, anything colored red or purple or any other foods with pulp.
• It is important for you to drink the additional amount of clear liquids listed in the prescribing information.
• You may have stomach-area (abdomen) bloating after your first dose of MoviPrep.
  • If you have severe stomach-area (abdomen) discomfort or bloating, stop drinking MoviPrep for a short time or wait a longer time between each dose of MoviPrep until your stomach-area symptoms improve. If your stomach-area discomfort or bloating continues, tell your healthcare provider.
• If you take too much MoviPrep, call your healthcare provider.

Important information on taking MoviPrep:

• You must drink all of the Dose 1 and Dose 2 of MoviPrep with either dosing regimen option. Make sure you finish Dose 2 at least 2 hours before your colonoscopy.
• After completing Dose 2, it is important that you drink additional clear liquids (including water), but you must stop drinking all liquids at least 2 hours before your colonoscopy.
• MoviPrep must be mixed with water. Do not add any other ingredients to MoviPrep.
• Do not mix MoviPrep with starch-based thickeners
• After you start taking MoviPrep, you can only drink clear liquids (no solid foods) until after your colonoscopy. Examples of clear liquids include:
  • water
  • clear fruit juices without pulp including apple, white grape, or white cranberry
  • strained limeade or lemonade
  • coffee or tea (do not use any dairy or non-dairy creamer)
  • clear broth
  • clear soda
  • gelatin (without added fruit or topping, no red or purple)
  • popsicles (without pieces of fruit or pulp, no red or purple)
• Drink plenty of clear liquids before, during, and after you take MoviPrep, up until 2 hours before your colonoscopy, to help prevent fluid loss (dehydration).
• Do not eat or drink anything within 2 hours before your colonoscopy.
• Do not eat or drink alcohol, milk, anything colored red or purple or containing pulp.
• Do not take other laxatives while taking MoviPrep.
• Do not take any medicines by mouth (oral) within 1 hour before or after starting each dose of MoviPrep.
• Do not eat any solid food while taking MoviPrep until after your colonoscopy.

Do not take MoviPrep if your healthcare provider has told you that you have:

• a blockage in your intestine (bowel obstruction).
• an opening in the wall of your stomach or intestine (bowel perforation).
• problems with food and fluid emptying from your stomach (gastric retention).
• a problem with food moving too slowly through your intestines (ileus).
• a very dilated intestine (toxic megacolon).
• an allergy to any of the ingredients in MoviPrep. See the end of this Medication Guide for a complete list of ingredients in MoviPrep.

Before taking MoviPrep, tell your healthcare provider about all of your medical conditions, including if you:

• have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
• have heart problems.
• have seizures or take medicines for seizures.
• have kidney problems or take medicines for kidney problems.
• have stomach or bowel problems, including ulcerative colitis.
• have problems with swallowing, gastric reflux, or if you inhale food or fluid into your lungs when eating or drinking (aspirate).
• have a condition called glucose-6-phosphate dehydrogenase (G6PD) deficiency that destroys red blood cells.
• are withdrawing from alcohol or benzodiazepines.
• have phenylketonuria (PKU). MoviPrep contains phenylalanine.
• are allergic to any of the ingredients in MoviPrep.
• are pregnant or plan to become pregnant. It is not known if MoviPrep will harm your unborn baby. Talk to your healthcare provider if you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if MoviPrep passes into your breast milk. You and your healthcare provider should decide if you will take MoviPrep while breastfeeding.