Nulytely (Oral)

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

PEG-electrolyte solution is a laxative. It works by making you have diarrhea to clear your colon. Cleaning your colon will help your doctor see the inside of your colon more clearly during the colonoscopy.

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

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

Contact your doctor immediately if you notice a decrease in urine, dizziness, fainting, headaches, or vomiting. These could be signs of excessive fluid loss (dehydration).

Contact your doctor right away if you experience any changes in your heart rhythm. You may feel dizzy or faint, or notice a fast, pounding, or uneven heartbeat. Be sure to inform your doctor if you have a history of heart rhythm problems, including QT prolongation.

This medicine may lead to serious bowel issues (e.g., colon ulcers, ischemic colitis). Reach out to 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 risk is higher if you are taking medication for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have low sodium levels in your blood (hyponatremia). Discuss any concerns with your doctor.

Stay hydrated before, during, and after using this medicine. Drink extra fluids to help you urinate more, which may help prevent kidney problems.

Do not take additional stimulant laxatives (e.g., bisacodyl, sodium picosulfate) with this medicine. This includes both prescription and nonprescription (over-the-counter [OTC]) medications.

In deciding to use a medicine, the risks must be weighed against the benefits. This is a decision you and your doctor will make together. 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 allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of PEG-electrolyte solution in children 6 months of age and older. Safety and effectiveness have not been established in children younger than 6 months.

Geriatric

Studies have not shown any specific problems that would limit the use of PEG-electrolyte solution in elderly patients. However, older patients are more likely to have age-related kidney issues, 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 in other cases, two different medicines may be used together even if an interaction might occur. If you are 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 selected based on 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 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.

• 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 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 change the dose or how often you use one or both of the medicines.

• Chloroquine
• Licorice

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with 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 the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Unstable angina (chest pain) or
• Recent heart attack or
• Heart disease (e.g., 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 (e.g., alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—May increase the risk for seizures, arrhythmia, or kidney problems.

• Congestive heart failure or
• Dehydration or
• History of heart rhythm problems (e.g., prolonged QT interval, uncontrolled arrhythmia) or
• Inflammatory bowel disease or
• Kidney disease 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 must be corrected first before using this medicine.

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

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away 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. Your health care professional may also 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.

In the U.S.

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

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Laxative, Hyperosmotic

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.