Pronunciation:

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

Classifications:

Pharmacologic—

Ascorbic Acid

Uses of This Medicine:

Polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride combination is used to cleanse the bowels before a procedure called colonoscopy. This medicine is a laxative. It works by causing you to have diarrhea to clean your colon. Cleaning your colon will help your doctor see the inside of your colon more clearly during colonoscopy or other procedures.

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 polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride combination 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 polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride combination in the elderly. However, elderly patients are more likely to have unwanted effects and age-related liver, kidney, or heart problems, which may require caution for 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.

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

• Angina (chest pain), unstable or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, prolonged QT interval, 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 disease 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—Must be corrected first before starting treatment with this medicine.

• Gastric retention (problems with emptying of food or fluid from the stomach) or
• Stomach or bowel problems (eg, blockage, ileus, perforation) or
• Toxic megacolon (a very dilated intestine)—Should not be used in patients with these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency with an infection, or a history of hemolysis—Use with caution. This medicine contains sodium ascorbate and ascorbic acid which may cause serious unwanted effects in patients with this condition.

• Phenylketonuria—Use with caution. This medicine contains phenylalanine which may cause serious unwanted effects in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To prepare the mixture:

• Empty the contents of the packet (Dose 1) into the mixing container.
• Add at least 16 ounces (oz) of water to the fill line. Do not add any other liquid or starch-based thickeners to the medicine.
• Mix with a spoon or put the lid on the container and shake for about 2 to 3 minutes until the mixture is completely dissolved.
• Rinse the mixing container with water and refill it with clear liquids (16 oz) within 30 minutes.
• For Dose 2, repeat the steps for Dose 1, but you should empty the contents of the two dose pouches (A and B) into the mixing container at the same time.

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) up until 2 hours before the time of the test. However, check first with your doctor. Do not eat or drink alcohol, milk, or anything red or purple liquids or foods with pulp.

If you take other medicines, take them at least 1 hour before you start this medicine.

You may take this medicine 2 ways: the One-Day Morning Dosing schedule or the Two-Day Split Dosing schedule.

• One-Day Morning Dosing:
  • You may eat a light breakfast and lunch one day before the procedure. You may also have clear broth soup or plain yogurt for dinner (about 8 PM). You should not eat the morning of your colonoscopy.
• Two-Day Split Dosing:
  • You may eat a light breakfast and lunch one day before the procedure. You should finish eating your lunch at least 3 hours before you start using this medicine.

You should have your first loose stool or mild diarrhea about 1 to 2 hours after you drink the medicine. 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 oral dosage form (powder for solution):
  • For cleansing the bowels:
    • Adults—Your doctor will tell you how to use this medicine, either by the One-Day Morning Dosing option or the Two-Day Split Dosing option.
      • One-Day Morning Dosing: Take the first dose the morning of your colonoscopy (between 3 AM and 7 AM), then the second dose about 2 hours after. You should have taken the second dose at least 2 hours before your colonoscopy.
      • Two-Day Split Dosing: Take the first dose in the evening (between 4 PM and 8 PM), then the second dose 12 hours after. You should have taken the second dose at least 2 hours before your colonoscopy.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

You may store the unopened medicine and the oral liquid at room temperature or in the refrigerator. You may use this medicine within 6 hours after mixing it with water. Throw away any unused oral liquid after 6 hours.

Precautions While Using This Medicine:

It is very important that your doctor check your progress to make sure that this medicine is working properly and 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.

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.

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 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, trouble 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:

Less common

Blurred vision

confusion

decreased urination

dizziness

dry mouth

fainting

full or bloated feeling

headache

heartburn

increase in heart rate

irregular heartbeat

lightheadedness

muscle cramps or pain

nervousness

numbness, tingling, pain, or weakness in the hands or feet

pounding in the ears

pressure in the stomach

rapid breathing

seizures

slow or fast heartbeat

stomach pain or discomfort

sunken eyes

swelling of the stomach area

thirst

trembling

unusual tiredness or weakness

vomiting

weakness and heaviness of the legs

wrinkled skin

Rare

Chest tightness

fast, irregular, pounding, or racing heartbeat or pulse

fever

hives, itching, rash

hoarseness

irritation

joint pain, stiffness, or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

trouble breathing or swallowing

Incidence not known

Bloody or black, tarry stools

blue lips and fingernails

chest pain

constipation

coughing that sometimes produces a pink frothy sputum

difficult, fast, noisy breathing

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

pale skin

rapid weight gain

severe stomach pain

swelling in the legs and ankles

swelling of the neck

throat tightness

tingling of the hands or feet

tremor

unusual weight gain or loss

vomiting of blood or material that looks like coffee grounds

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

Nausea

Less common

Sore throat

stuffy or runny nose

Rare

Discomfort in the anus or rectum

feeling of warmth

headache, severe and throbbing

lack or loss of strength

redness of the face, neck, arms and occasionally, upper chest

sleepiness or unusual drowsiness

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.