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Polyethylene Glycol, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid

Side Effects

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 upper stomach
  • Pressure in the stomach
  • Stomach pain
  • Swelling of abdominal or stomach area
  • Vomiting

Rare

  • Coma
  • Confusion
  • Convulsions
  • Decreased urine output
  • Dizziness
  • Dry mouth
  • Fast or irregular heartbeat
  • Headache
  • Increased thirst
  • Loss of appetite
  • Mood changes
  • Muscle pain or cramps
  • Numbness or tingling in hands, feet, fingertips, lips, or mouth
  • Shortness of breath
  • Swelling of face, ankles, or hands
  • Unusual tiredness or weakness

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 or itching around anus
  • Difficulty in sleeping
  • Feeling unusually cold
  • General feeling of discomfort or illness
  • Hunger
  • Nausea
  • Pain around anus
  • Shivering
  • Thirst

Less common

  • Acid or sour stomach
  • Belching
  • Heartburn
  • 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.

Precautions

Your doctor may need to check your blood before and after the medical test to check for possible unwanted side effects from the medicine .

Do not take any oral medicine for at least one hour after taking this medicine .

Proper Use

To prepare the oral solution:

  • Empty the powder into a glass container and add one liter of lukewarm water.
  • Shake well until all the ingredients are dissolved.
  • Do not add any other ingredients, such as flavoring, to the solution.
  • After you mix the solution, you must use it within 24 hours.
  • You may refrigerate the solution before drinking .

Drink the mixture exactly as directed. Most people need to drink all of the oral solution to get completely clear stools .

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

  • The night before the test, drink the first liter of oral solution over one 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 one hour and then drink another 0.5 liters of clear liquid at least an hour before the test; or
  • The night (around 6 pm) before the test, drink the first liter of the oral solution over one 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 .

About 1 hour after you drink the first glass of liquid, you may 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 .

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 cleaning the colon:
    • For oral dosage form (powder for oral solution):
      • Adults—Drink one full glass (8 ounces) of the oral solution every 15 minutes, as instructed by your doctor.
      • 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.

Store the carton containing the pouches of powder and the liquid for mixing with the powder at room temperature, away from heat, moisture, or light. Once the powder has been mixed with the liquid, refrigerate the solution and use it within 24 hours .

Before Using

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of this medicine in the elderly. However, increased sensitivity to the effects of this medicine in some elderly cannot be ruled out .

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

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.

  • Amantadine
  • Atropine
  • Belladonna
  • Belladonna Alkaloids
  • Benztropine
  • Biperiden
  • Clidinium
  • Darifenacin
  • Dicyclomine
  • Eplerenone
  • Glycopyrrolate
  • Hyoscyamine
  • Methscopolamine
  • Oxybutynin
  • Procyclidine
  • Scopolamine
  • Solifenacin
  • Tolterodine
  • Trihexyphenidyl

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
  • Canrenoate
  • Captopril
  • Cilazapril
  • Delapril
  • Enalaprilat
  • Enalapril Maleate
  • Fosinopril
  • Imidapril
  • Indomethacin
  • Licorice
  • Lisinopril
  • Moexipril
  • Pentopril
  • Perindopril
  • Quinapril
  • Ramipril
  • 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:

  • Blockage or obstruction of the intestine or
  • Gastric retention or
  • Ileus or
  • Perforated bowel or
  • Toxic colitis or
  • Toxic megacolon or
  • Ulcerative colitis, severe—This medicine may make these conditions worse .
  • Electrolyte imbalance (e.g., low sodium or potassium in the blood)—This medicine may worsen condition and increase your risk of having seizures .
  • Glucose-6-phosphate dehydrogenase deficiency—Use with caution. This medicine contains sodium ascorbate and ascorbic acid. This may increase your risk of hemolytic anemia .
  • Phenylketonuria—Use with caution. This medicine contains phenylalanine .
  • Poor gag reflex or
  • Swallowing problem—This medicine may cause severe lung problems if aspirated; may also cause severe bloating or stomach pain .

Description

This medicine is used to clean the colon (large bowel or lower intestine) before certain tests .

This medicine acts like a laxative. It causes liquid stools or mild diarrhea. In this way, it flushes all solid material from the colon, so the doctor can have a clear view of the colon .

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

Drink lots of fluids before, during or after the use of this medicine .

Dinner should be at least one hour before the start of treatment. You may have clear soup or plain yogurt for dinner .

Do not eat any solid food from the start of treatment until after the test .