GaviLyte-C with Flavor Pack (Oral)

Polyethylene glycol (PEG) and electrolytes combination solution is used to clean out the colon (bowel) before specific medical tests (for example, colonoscopy, barium enema X-ray exam) or colon surgery.

The PEG-electrolyte solution is a laxative. It causes diarrhea to help clear your colon. Cleaning your colon helps your doctor see the inside more clearly during a colonoscopy or other procedures.

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

It is important that your doctor checks you closely to ensure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

Contact your doctor right away if you have decreased urination, dizziness, headache, or vomiting. These could be signs of losing too much body fluid (dehydration).

Contact your doctor immediately if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you might experience a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have a history of heart rhythm issues, including QT prolongation.

This medicine may increase your risk for seizures. This risk is higher if you take medicine for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have low sodium levels in your blood (hyponatremia). Talk to your doctor if you have any concerns.

This medicine may cause serious bowel problems (for example, colon ulcers, ischemic colitis). Check with your doctor immediately 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.

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 or swallowing, or large, hive-like swelling on your 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, including those to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how PEG-electrolyte solution affects children. Its safety and effectiveness have not been established for this age group.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of PEG-electrolyte solution. However, older patients may be more likely to experience serious side effects (e.g., upper GI bleeding, trouble breathing), so caution is recommended when using this medicine in these patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should never be used together, in other cases, it may be possible to use two different medicines together, even if interactions could happen. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the following medicines. The interactions listed below are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose 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 situations. If both medicines are prescribed together, 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 adjust the dose or frequency of one or both medicines.

• Chloroquine
• Licorice

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to potential interactions. Drinking alcohol or using tobacco may also lead to interactions. Talk to your healthcare professional about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Angina (chest pain), unstable 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 before using this medicine.

• Gastric retention (problems with emptying food or fluid from the stomach) or
• Stomach or bowel issues (e.g., blockage, ileus, perforation) or
• Toxic megacolon (a very dilated 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 require medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bloody or black, tarry stools
• Chest pain
• Constipation
• Severe stomach pain
• Swelling of the neck
• Trouble breathing
• Vomiting
• Vomiting of blood or material that looks like coffee grounds

Incidence not known

• Bloody urine
• Blue lips and fingernails
• Blurred vision
• Chest tightness
• Cough
• Coughing that sometimes produces a pink frothy sputum
• Decreased frequency or amount of urine
• Diarrhea
• Difficulty swallowing
• Dizziness
• Fainting
• Fast, noisy breathing
• Fast, slow, or irregular heartbeat
• Hives, itching, skin rash
• Increased sweating
• Increased thirst
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of appetite
• Lower back or side pain
• Nausea
• Nervousness
• Pale skin
• Pounding in the ears
• Rapid weight gain
• Rectal bleeding
• Seizures
• Stomach tenderness
• Tingling of the hands or feet
• Tremor
• Unusual tiredness or weakness

Some side effects may happen 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 lessen 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

• Stomach fullness

Less common

• Burning or itching around the anus
• Stomach cramps

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.

• Colyte
• Colyte with Flavor Packs
• GaviLyte-C with Flavor Pack
• Golytely

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Laxative, Hyperosmotic

Your doctor may have special instructions for you, depending on the type of test you are going to have. If you have not received such instructions, or if you do not understand them, check with your doctor.

Take this medicine exactly as directed. Otherwise, the test you are going to have may not work as well and may have to be done again.

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

It is best that you do not eat any solid food for 3 to 4 hours before you start using this medicine. You must not eat anything for 2 hours before starting this medicine. Once you drink your first dose, do not eat anything until after you are finished with your test.

You may drink clear liquids (eg, water, ginger ale, decaffeinated cola or tea, broth, gelatin) up until 2 hours before the time of the test. However, check first with your doctor. Do not drink red or purple liquids.

To use the medicine:

• Mix the powder with water before using it. Do not swallow the powder directly. 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 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 the liquid, it can be given through a tube inserted into your nose.

Do not take any medicine by mouth within 1 hour before using PEG and electrolytes combination solution. Do not take another laxative while using this medicine.

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 cleansing of the colon: For oral dosage form (powder for oral solution): Adults—240 milliliters (mL) every 10 minutes. The first dose is usually taken early in the evening on the day before your medical test. 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.

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.