Polyethylene glycol 3350, sodium and potassium salts (Oral route)
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
- GaviLyte-N with Flavor Pack
- TriLyte w/Flavor Packs
- Powder for Solution
- Powder for Suspension
Uses of This Medicine:
The polyethylene glycol (PEG), sodium and potassium salts solution is used to cleanse the colon (bowel) before a medical test (eg, colonoscopy).
The PEG, sodium and potassium salts 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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of PEG, sodium and potassium salts solution in children 6 months of age and older. However, safety and efficacy have not been established in children younger than 6 months.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of PEG, sodium and potassium salts 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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
- Belladonna Alkaloids
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.
- Enalapril Maleate
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.
- Cholic Acid
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, poorly controlled or
- Cardiomyopathy (heart disease) or
- Congestive heart failure or
- Dehydration or
- Heart attack, recent or
- Heart rhythm problems (eg, prolonged QT interval), 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 in the blood) or
- Trouble swallowing—May cause side effects to become worse.
- Bowel blockage or
- Bowel perforation (hole in the intestine) or
- Gastric retention (problem with emptying the stomach) or
- Ileus (intestine stops moving) or
- Toxic colitis (very inflamed intestine) or
- Toxic megacolon (very dilated or swollen intestine)—Should not be used in patients with these conditions.
- Inflammatory bowel disease or
- Kidney problems or
- Seizures, history of or
- Ulcerative colitis, active—Use with caution. May make these conditions worse.
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, your test may not work correctly and may have to be repeated.
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 oral medicines starting 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:
- The powder must be mixed with water. Do not swallow the powder.
- If you are using a flavor pack, add 1 pack to the bottle before adding water. Do not add any additional flavoring. Throw away extra flavor packs.
- Add lukewarm water to the fill mark on the bottle.
- Shake well until all of the powder is dissolved.
- Keep the mixture in the refrigerator and use it within 48 hours.
- Follow your doctor's orders about when to begin drinking the mixture.
- Drink the mixture quickly instead of sipping it.
- The medicine will start working about 1 hour after you drink the first glass. You will have diarrhea at first then very watery stools.
- Keep drinking the mixture until your stools are clear and free of solids.
- Throw away any unused mixture.
- If you cannot swallow liquids, the mixture can be given through a tube inserted into your nose.
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.
- For cleansing of the colon:
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.
After the powder is mixed with water, keep the mixture in the refrigerator. Use the liquid within 48 hours after adding water. Throw away any unused portion.
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).
Tell your doctor right away if you have severe stomach bloating, distension, or pain after taking this medicine.
If you develop a skin rash, hives, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor right away.
Do not take additional stimulant laxatives (eg, bisacodyl) with this medicine. This includes prescription or nonprescription (over-the-counter [OTC]) medicines.
Side Effects of This Medicine:
- difficulty with swallowing
- fast heartbeat
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin
- shortness of breath
- skin rash, hives or welts, or itching
- tightness in the chest
- unusual tiredness or weakness
- Incidence not known
- Bloody or black, tarry stools
- blue lips and fingernails
- chest pain
- coughing that sometimes produces a pink frothy sputum
- difficult or labored breathing (sudden)
- difficult, fast, or noisy breathing, sometimes with wheezing
- increased sweating
- pale skin
- severe stomach pain
- swelling in the legs and ankles
- tightness in the chest (sudden)
- vomiting of blood or material that looks like coffee grounds
- More common
- Abdominal or stomach fullness
- Less common
- Abdominal or stomach cramps
- burning or itching around the anus
- Blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, or scaly skin
- runny nose
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:
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:
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.
Last Updated: 11/4/2014