MoviPrep

What is MoviPrep?

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.

Description

MoviPrep® consists of 4 separate pouches (2 of pouch A and 2 of pouch B) containing white to yellow powder for reconstitution.  Each pouch A contains 100 grams of polyethylene glycol (PEG) 3350, NF, 7.5 grams of sodium sulfate, USP, 2.691 grams of sodium chloride, USP, and 1.015 grams of potassium chloride, USP, plus the following excipients: aspartame, NF (sweetener), acesulfame potassium, NF (sweetener), and lemon flavoring. Each pouch B contains 4.7 grams of ascorbic acid, USP and 5.9 grams of sodium ascorbate, USP.

When 1 pouch A and 1 pouch B are dissolved together in water to a volume of 1 liter, MoviPrep (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid) is an oral solution having a lemon taste.

The entire, reconstituted, 2-liter MoviPrep colon preparation contains 200 grams of PEG-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring.

Mechanism of Action

MoviPrep produces a watery stool leading to cleansing of the colon. The osmotic activity of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, when taken with 1 liter of additional clear fluid, usually results in no net absorption or excretion of ions or water.

The pharmacokinetics of MoviPrep has not been studied in patients with renal or hepatic insufficiency.

What is the most important information I should know about MoviPrep?

MoviPrep and other bowel preparations can cause serious side effects, including:

• Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:
  • abnormal heartbeats that can cause death.
  • seizures. This can happen even if you have never had a seizure.
  • kidney problems.

Your chance of having fluid loss and changes in body salts with MoviPrep is higher if you:

• have heart problems.
• have kidney problems.
• take water pills (diuretics), high blood pressure medicine, or non-steroidal anti-inflammatory drugs (NSAIDS).

Tell your healthcare provider right away if you have any of these symptoms of serious loss of body fluid (dehydration) while taking MoviPrep:

• vomiting
• urinating less often than normal
• dizziness
• headache

See “What are the possible side effects of MoviPrep?” for more information about side effects.

Who should not take MoviPrep?

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 leaflet for a complete list of ingredients in MoviPrep.

What should I tell my healthcare provider before taking 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.

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

MoviPrep may affect how other medicines work. Do not take medicines by mouth 1 hour before or after the start of MoviPrep.

Especially tell your healthcare provider if you take:

• medicines to treat a blood salt (electrolyte) imbalance.
• medicines for blood pressure or heart problems.
• medicines for seizures (antiepileptics).
• medicines for kidney problems.
• water pills (diuretics).
• non-steroidal anti-inflammatory drugs (NSAID).
• laxatives. Do not take other laxatives while taking MoviPrep.
• medicines for depression or other mental health problems.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How to take MoviPrep?

See the Instructions for Use that come with MoviPrep for dosing instructions. You must read, understand, and follow these instructions to take MoviPrep the right way.

• 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 Instructions for Use.
• 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 long 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.

What are the 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
  • heart problems
  • seizures
  • dizziness
  • kidney problems
  • 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
  • raised red patches on your skin (hives)
  • kidney problems
  • swelling of the face, lips, tongue and throat
  • itching

The most common side effects of MoviPrep include:

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

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.

General information about the safe and effective use of MoviPrep

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use MoviPrep for a condition for which it was not prescribed. Do not give MoviPrep to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about MoviPrep. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

For more information, call 1-800-321-4576 or go to www.MoviPrep.com.

What are the ingredients in MoviPrep?

Active ingredients:
Pouch A: polyethylene glycol (PEG) 3350, sodium sulfate, sodium chloride, potassium chloride.
Pouch B: ascorbic acid and sodium ascorbate.

Inactive ingredients:
Pouch A: aspartame, acesulfame potassium, and lemon flavoring.