Pronunciation:

pol-ee-ETH-i-leen GLYE-kol 3350, SOE-dee-um SUL-fate, SOE-dee-um KLOR-ide, poe-TAS-ee-um KLOR-ide, as-KORE-bik AS-id, SOE-dee-um a-SKOR-bate

Brand Names:

• MoviPrep

Dosage Forms:

• Powder for Solution

Uses of This Medicine:

The polyethylene glycol (PEG), electrolytes, and ascorbic acid combination is used to cleanse the colon (bowel) in preparation for a procedure called a colonoscopy.

MoviPrep® is a laxative. It works by causing you to have diarrhea to clean your colon. Cleaning your colon will help your doctor see inside of it more clearly during a colonoscopy.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of MoviPrep® in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of MoviPrep® in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, and unwanted effects (eg, fluid or electrolyte imbalance), which may require caution in patients receiving this medicine.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance 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 required 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 cause an increased 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 change the dose or how often you use one or both of the medicines.

• Indinavir
• Licorice

Other interactions—

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

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to lemon flavoring (eg, citral, lemon oil and lime oil, maltodextrin, xanthan gum, or vitamin E) or
• Gastric retention (problems with emptying of food or fluid from the stomach) or
• Stomach or bowel problems (eg, 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
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, prolonged QT, uncontrolled arrhythmia), history of 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 (eg, 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
• Seizures, history of or
• Trouble swallowing or
• Ulcerative colitis, active and severe—Use with caution. May make these conditions worse.

• Fluid and electrolyte imbalance—Use with caution. These conditions may increase risk for more side effects and must be corrected first 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 make this condition worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is important that your doctor check your progress closely for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

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

Contact your doctor right away if you have decreased urination, dizziness, headache, or vomiting. These could be symptoms of a loss of too much body fluid (dehydration).

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

This medicine may increase your risk for seizures. This is more likely to occur if you take medicine for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have low sodium level in the blood (hyponatremia). Talk to your doctor if you have any concerns.

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

Keep yourself hydrated before, during, and after using this medicine. Drink extra fluids so you will pass more urine. This may help prevent kidney problems. Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may cause serious bowel problems (eg, colon ulcers, ischemic colitis). Check with your doctor right away if you have stomach pain and tenderness, bloody stools, or rectal bleeding.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals after using this medicine.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately 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 occur 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 be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any 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.