Polyethylene glycol 3350, electrolytes, and ascorbic acid (Oral)

The polyethylene glycol (PEG), electrolytes, and ascorbic acid combination is used to clean the colon (bowel) before a procedure called a colonoscopy.

MoviPrep® is a laxative. It causes diarrhea to help clean your colon. Cleaning your colon will allow your doctor to see inside it more clearly during a colonoscopy.

This medicine is available only with your doctor's prescription.

It is important that your doctor monitors your progress closely for any issues that may arise from this medicine. Blood and urine tests may be necessary to check for side effects.

Do not use this medicine with other laxatives (e.g., bisacodyl [Dulcolax®] or sodium picosulfate [Dulcolax® Pico, CitraFleet®]).

Contact your doctor immediately if you experience decreased urination, dizziness, headache, or vomiting. These may be signs of dehydration.

Contact your doctor right away if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you may have a fast, pounding, or uneven heartbeat. It is important for your doctor to know if you have a history of heart rhythm issues, including QT prolongation.

This medicine may raise your chance of having seizures. This risk is higher if you take medication for depression, if you are withdrawing from alcohol or benzodiazepines, or if you have low sodium levels in your blood (hyponatremia). Discuss any concerns with your doctor.

If you experience severe bloating or stomach discomfort after your first dose, you may need to wait until your symptoms improve before taking the second dose, or you can try taking smaller sips of the mixture.

Stay hydrated before, during, and after using this medicine. Drink extra fluids to help increase urine output, which may help prevent kidney issues. Contact your doctor right away if you notice bloody urine, a decrease in urine frequency or amount, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, difficulty breathing, unusual tiredness or weakness, vomiting, or weight gain. These could indicate a serious kidney problem.

This medicine may lead to serious bowel issues (e.g., colon ulcers, ischemic colitis). Contact your doctor immediately if you have stomach pain and tenderness, bloody stools, or rectal bleeding.

This medicine may cause severe allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and need urgent medical care. Inform your doctor immediately if you develop a rash, itching, hoarseness, trouble breathing or swallowing, or significant swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to think about the risks of taking the medicine compared to the benefits it may provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other types of allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how MoviPrep® affects children. Safety and effectiveness have not been determined for this age group.

Geriatric

Studies so far have not shown any specific issues for older adults that would limit the usefulness of MoviPrep®. However, older patients are more likely to have age-related liver, kidney, or heart problems, and side effects (like fluid or electrolyte imbalance) may occur, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there could be an interaction. In these situations, your doctor may adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Eplerenone
• Fesoterodine
• Glycopyrrolate
• Trospium

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril
• Amiloride
• Amygdalin
• Benazepril
• Bisacodyl
• Canrenoate
• Captopril
• Cilazapril
• Deferoxamine
• Delapril
• Fosinopril
• Imidapril
• Indomethacin
• Licorice
• Lisinopril
• Moexipril
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Senna
• Sodium Picosulfate
• Sparsentan
• Spirapril
• Spironolactone
• Temocapril
• Trandolapril
• Triamterene
• Zofenopril

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Indinavir
• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect your use of this medicine. Make sure to tell your doctor about any other medical problems you have, especially:

• Allergy to lemon flavoring (like citral, lemon oil and lime oil, maltodextrin, xanthan gum, or vitamin E) or
• Gastric retention (difficulty emptying food or fluid from the stomach) or
• Stomach or bowel problems (like blockage, ileus, perforation) or
• Toxic colitis or
• Toxic megacolon (a very dilated intestine)—Should not be used in patients with these conditions.

• Angina (chest pain), unstable or
• Recent heart attack or
• Heart disease (like cardiomyopathy) or
• History of heart rhythm problems (like prolonged QT, uncontrolled arrhythmia) or
• Hypocalcemia (low calcium in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium level in the blood) or
• Withdrawal from alcohol or benzodiazepines (like alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—May increase risk for seizures, arrhythmia, or kidney problems.

• Congestive heart failure or
• Dehydration or
• Inflammatory bowel disease or
• Kidney problems or
• History of seizures or
• Trouble swallowing or
• Active and severe ulcerative colitis—Use with caution. May worsen these conditions.

• Fluid and electrolyte imbalance—Use with caution. These conditions may increase the risk for more side effects and should be corrected before using this medicine.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—This medicine contains sodium ascorbate and ascorbic acid, which can increase your risk of hemolytic anemia.

• Phenylketonuria—This medicine contains phenylalanine, which can worsen this condition.

Along with its necessary effects, a medicine can sometimes cause unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Full or bloated feeling
• Pain in the upper stomach
• Pressure in the stomach
• Stomach pain
• Swelling of the stomach area
• Vomiting

Rare

• Confusion
• Decreased urine output
• Dizziness
• Dry mouth
• Fast or irregular heartbeat
• Headache
• Increased thirst
• Loss of appetite
• Loss of consciousness
• Muscle pain or cramps
• Numbness or tingling in the hands, feet, fingertips, lips, or mouth
• Seizures
• Swelling of the face, ankles, or hands
• Unusual tiredness or weakness

Incidence not known

• Blistering, crusting, irritation, itching, or reddening of the skin
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody or black, tarry stools
• Bloody urine
• Blue lips and fingernails
• Blurred vision
• Chest pain or tightness
• Chills
• Constipation
• Cough
• Coughing that sometimes produces a pink frothy sputum
• Cracked, dry, scaly skin
• Difficult, fast, noisy breathing
• Difficulty swallowing
• Fainting
• Fast, pounding, or irregular heartbeat or pulse
• Fever
• Heartburn
• Hives, itching, skin rash
• Increase in heart rate
• Increased sweating
• Lightheadedness
• Lower back or side pain
• Nausea
• Nervousness
• Pale skin
• Pounding in the ears
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid breathing
• Rapid weight gain
• Runny nose
• Severe stomach pain
• Slow heartbeat
• Sunken eyes
• Swelling of the neck
• Thirst
• Throat tightness
• Tingling of the hands or feet
• Tremor
• Trouble breathing
• Unusual weight gain or loss
• Vomiting of blood or material that looks like coffee grounds
• Wrinkled skin

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have questions about them:

More common

• Burning, itching, or pain around the anus
• Difficulty with sleeping
• Feeling unusually cold
• General feeling of discomfort or illness
• Hunger
• Shivering

Less common

• Belching
• Indigestion
• Stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• MoviPrep

Available Dosage Forms:

• Powder for Solution

Your doctor may have special instructions for you, depending on the schedule of your colonoscopy you are going to have. If you have not received such instructions, or if you do not understand them, check with your doctor in advance.

Take this medicine exactly as directed by your doctor. Otherwise, the test you are going to have may not work as well and may have to be done again.

This medicine comes with a Medication Guide and patient instructions. You must read, understand, and follow these instructions carefully. Ask your doctor if you have any questions.

It is best if you do not eat any solid food before taking this medicine and until after your colonoscopy.

You may drink clear liquids (eg, water, clear fruit juices (without pulp), strained limeade or lemonade, coffee or tea, broth, soda, gelatin, popsicles) before, during, and up until 2 hours before the time of your colonoscopy. Do not eat or drink alcohol, milk, anything colored red or purple or containing pulp. However, check first with your doctor.

You may have clear soup or plain yogurt for dinner on the evening that you start taking MoviPrep®. Dinner should be at least 1 hour before you take MoviPrep®.

To prepare the medicine:

• The powder must be mixed with water before it is used. Add lukewarm water to the fill mark on the bottle. Do not add any extra flavorings or starch-based thickeners to the solution.
• Shake well until all the ingredients are dissolved.
• After you mix the solution, you must use it within 24 hours. You may refrigerate the solution before drinking.
• You will need to drink 8 ounces (240 milliliters) of the mixed medicine about every 15 minutes until it is gone.
• About 1 hour after you drink the first glass of liquid, you should have your first loose stool or mild diarrhea. This is how the medicine cleans out your bowels. You may have bloating or an upset stomach before the loose stools start.
• If you cannot swallow the liquid, tell your doctor right away.

You will need to consume 2 liters (about 64 ounces) of the oral solution and one additional liter (about 32 ounces) of clear liquid before the test. You may do one of the following ways:

• Split-dose (2-day regimen) method: The night before the test, drink the first liter of oral solution over 1 hour and then drink 0.5 liters (about 16 ounces) of clear liquid. Then, on the morning of the test, drink the second liter of the oral solution over 1 hour and then drink another 0.5 liters of clear liquid at least 2 hours before the test.
• Evening-only (1-day regimen) method: The night (around 6 pm) before the test, drink the first liter of the oral solution over 1 hour. After about 1.5 hours, drink the second liter of the oral solution over one hour. Drink an additional liter of clear liquid the night before the test.
• Do not eat or drink anything 2 hours before your colonoscopy, unless your doctor provides you with different instructions.

Do not take any medicine by mouth within 1 hour before using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder for oral solution):For cleansing the colon: Adults—Your doctor will prescribe your dosing regimen to be taken the day or night before your colonoscopy. The dose is usually 8 ounces (240 milliliters) every 15 minutes. Two-day split dosing regimen: Take the first dose between 10 to 12 hours before the second dose. The second dose must be taken at least 3 ½ hours before your colonoscopy. One-day evening only dosing regimen: Take the first dose 3 1/2 hours before bedtime the evening before the colonoscopy. Take the second dose 1 1/2 hours after starting Dose 1. Children—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the mixed solution in the refrigerator and use it within 24 hours.