GaviLyte-N with Flavor Pack (Oral)

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

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

You can get this medicine only with your doctor's prescription.

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.

In deciding to use a medicine, you and your doctor need to consider the risks against the benefits of the medicine. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also tell your healthcare professional if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would limit the usefulness of PEG-electrolyte solution in children aged 6 months 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 usefulness of PEG-electrolyte solution in older adults. However, older patients may have age-related kidney issues, which may require caution when using this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the possible risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while using this medicine. The interactions listed are significant but not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or change some of your other medicines.

• 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, your doctor may adjust the dose or frequency of one or both 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 may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Chloroquine
• Licorice

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken near mealtime or with certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

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

• Angina (unstable chest pain)
• Recent heart attack
• Heart disease (e.g., cardiomyopathy)
• Hypocalcemia (low calcium in the blood)
• Hypokalemia (low potassium in the blood)
• Hypomagnesemia (low magnesium in the blood)
• Hyponatremia (low sodium level in the blood)
• Withdrawal from alcohol or benzodiazepines (e.g., alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—this may increase the risk of seizures, arrhythmia, or kidney problems.

• Congestive heart failure
• Dehydration
• History of heart rhythm problems (e.g., prolonged QT interval, uncontrolled arrhythmia)
• Inflammatory bowel disease
• Kidney disease
• History of seizures
• Trouble swallowing
• Active and severe ulcerative colitis—use with caution as it may worsen these conditions.

• Fluid and electrolyte imbalance—use with caution. These conditions may increase the risk of side effects and need to be corrected before using this medicine.

• Gastric retention (difficulty emptying the stomach)
• Stomach or bowel problems (e.g., blockage, ileus, perforation)
• Toxic megacolon (severely dilated or swollen intestine)—this medicine should not be used in these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might 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. Your health care professional may also be able to tell you how 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 happen 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.