Description
Polyethylene glycol (PEG) and electrolytes combination solution is used to cleanse the colon (bowel) before certain medical tests (eg, colonoscopy, barium enema X-ray exam) or colon surgery.
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 or other procedures.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of PEG-electrolyte solution in the pediatric population. Safety and efficacy have not been established.
Geriatric
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 serious side effects (eg, upper GI bleeding, trouble breathing), which may require caution in patients using this medicine.
Breastfeeding
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.
Drug Interactions
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.
- Aclidinium
- Amantadine
- Amitriptyline
- Amoxapine
- Anisotropine
- Atropine
- Belladonna
- Benztropine
- Biperiden
- Bornaprine
- Brompheniramine
- Butylscopolamine
- Carbinoxamine
- Carisoprodol
- Chlorpheniramine
- Chlorpromazine
- Cimetropium
- Clemastine
- Clidinium
- Clomipramine
- Clozapine
- Cyclobenzaprine
- Cyclopentolate
- Cyproheptadine
- Darifenacin
- Desipramine
- Dicyclomine
- Dimenhydrinate
- Diphenhydramine
- Doxepin
- Emepronium
- Eplerenone
- Fesoterodine
- Flavoxate
- Fluphenazine
- Glycopyrrolate
- Glycopyrronium Tosylate
- Homatropine
- Hydroxyzine
- Hyoscyamine
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
- Fosphenytoin
- Gefitinib
- Hydroxychloroquine
- Imidapril
- Indomethacin
- Infigratinib
- Isoniazid
- Ketoconazole
- Ledipasvir
- Licorice
- Lisdexamfetamine
- Lisinopril
- Mefenamic Acid
- Memantine
- Methamphetamine
- Moexipril
- Neratinib
- Octreotide
- Pazopanib
- Pentopril
- Perindopril
- Phenytoin
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
- Itraconazole
- Levothyroxine
- 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 (problems with emptying of food or fluid from the stomach) or
- Stomach or bowel problems (eg, blockage, ileus, perforation) or
- Toxic megacolon (a very dilated intestine)—Should not be used in patients with these conditions.
Proper Use
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.
- For oral dosage form (powder for oral solution):
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
It is important that your doctor check you closely to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Contact your doctor right away if you have decreased urination, dizziness, headache, or vomiting. These could be symptoms of a loss of too much body fluid (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 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.
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.
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 the 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.
Side Effects
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:
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 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
- Stomach fullness
Less common
- Burning or itching around the anus
- stomach cramps
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.
CON-XXXXXXXX
