Pronunciation:

pol-ee-ETH-i-leen GLYE-kol 3350, poe-TAS-ee-um KLOR-ide, SOE-dee-um bye-KAR-bo-nate, SOE-dee-um KLOR-ide

Brand Names:

• GaviLyte-N with Flavor Pack
• Nulytely
• TriLyte w/Flavor Packs

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Laxative, Hyperosmotic

Uses of This Medicine:

Polyethylene glycol (PEG) and electrolytes combination solution is used to cleanse the colon (bowel) before a medical test (eg, colonoscopy).

PEG-electrolyte solution 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.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of PEG- electrolyte solution in children 6 months of age and older. Safety and efficacy have not been established in children younger than 6 months.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of PEG-electrolyte solution in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients using 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.

• Acalabrutinib
• Alacepril
• Amiloride
• Amphetamine
• Atazanavir
• Benazepril
• Benzphetamine
• Bisacodyl
• Cabotegravir
• Canrenoate
• Captopril
• Cefuroxime Axetil
• Cilazapril
• Delapril
• Dextroamphetamine
• Digoxin
• Erdafitinib
• Fosinopril
• Gefitinib
• Imidapril
• Indomethacin
• Infigratinib
• Ketoconazole
• Ledipasvir
• Licorice
• Lisdexamfetamine
• Lisinopril
• Mefenamic Acid
• Memantine
• Methamphetamine
• Moexipril
• Neratinib
• Octreotide
• Pazopanib
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Rilpivirine
• Selpercatinib
• Senna
• Sodium Picosulfate
• Sotorasib
• 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.

• Chloroquine
• 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
• 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
• Heart rhythm problems (eg, prolonged QT interval, uncontrolled arrhythmia), history of 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—Use with caution. These conditions may increase risk for more side effects and must be corrected first before using this medicine.

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

Proper Use of This Medicine:

Your doctor may have special instructions based on the schedule for your colonoscopy. If you have not received 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 correctly and may have to be done again.

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

You must not eat any solid food for 2 hours before using this medicine. Once you drink your first dose of medicine, do not eat solid food until after your test.

You may drink water or clear liquids up until 2 hours before the test unless your doctor has different instructions. Do not drink red and purple liquids.

Do not take any medicines by mouth within 1 hour before taking this medicine. Oral medicines may not be absorbed properly while you are cleaning out your colon. Talk to your doctor if you have any questions.

To use the medicine:

• Mix the powder with water before using it. Do not swallow the powder. Add lukewarm water to the fill mark on the bottle. If you are using flavoring powder that comes with the medicine, add it before adding the water. Do not add any extra flavorings or starch-based thickeners to the medicine.
• Shake well until all of the ingredients are dissolved. Use the solution within 48 hours.
• Drink 240 milliliters (mL) of the mixed medicine about every 10 minutes until you finish all of the prepared solution or until your stool is clear and free of solid matter. It is best to drink it fast instead of sipping it.
• You should have your first loose stool or mild diarrhea about 1 hour 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.
• If you cannot swallow liquids, it can be given through a tube inserted into your nose.

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 of the colon:
    • Adults—240 milliliters (mL) (8 oz) every 10 minutes.
    • Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 25 milliliters (mL) per kilogram (kg) every hour.
    • Children younger than 6 months of age—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. Do not freeze. Throw away any unused liquid after 48 hours.

Precautions While Using This Medicine:

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

Contact your doctor right away if you have a decrease in urine, dizziness, fainting, headaches, or vomiting. These could be symptoms of too much fluid loss (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 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 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.

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.

Do not take additional stimulant laxatives (eg, bisacodyl, sodium picosulfate) with this medicine. This includes prescription or nonprescription (over-the-counter [OTC]) medicines.

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:

Rare

Chest tightness

cough

difficulty with swallowing

dizziness

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin

skin rash, hives or welts, or itching

trouble breathing

unusual tiredness or weakness

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, or noisy breathing

increased sweating

pale skin

severe stomach pain

swelling in the legs and ankles

vomiting

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

Bloating

nausea

stomach fullness

Less common

Burning or itching around the anus

stomach cramps

Rare

Blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, or scaly skin

runny nose

swelling

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.