Polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride (Oral)

Polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride combination is used to clean out the bowels before a procedure called colonoscopy. This medicine is a laxative. It causes diarrhea to help clear your colon. A clean colon allows your doctor to see the inside of it more clearly during colonoscopy or other procedures.

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

It is very important that your doctor check your progress to ensure that this medicine is working properly and to look for unwanted effects.

Do not use this medicine with other laxatives (e.g., bisacodyl [Dulcolax®] or sodium picosulfate [Dulcolax® Pico, CitraFleet®]).

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 could have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you have a history of heart rhythm problems, including QT prolongation.

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

This medicine may lead to serious bowel problems (e.g., colon ulcers, ischemic colitis). Contact your doctor immediately if you have stomach pain and tenderness, bloody stools, or rectal bleeding.

Stay hydrated before, during, and after using this medicine. Drink extra fluids so you will pass more urine. This may help prevent kidney problems. Contact your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, increased blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney problem.

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 develop a rash, itching, hoarseness, trouble breathing, trouble 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 you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. 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, inform your health care professional if you have any other types of allergies, like 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 polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride combination in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted to date have not shown any specific problems in older adults that would limit the usefulness of polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride combination in this age group. However, elderly patients are more likely to experience unwanted effects and age-related liver, kidney, or heart issues, which may require caution for patients 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.

Studies in women suggest that this medication poses minimal risk to the infant when used during 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. In these instances, your doctor may want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential importance 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 adjust the dose or how often you use one or both of the medicines.

• Alacepril
• Amiloride
• Amygdalin
• Benazepril
• Bisacodyl
• Canrenoate
• Captopril
• Cilazapril
• Deferoxamine
• Delapril
• Fosinopril
• Imidapril
• Indomethacin
• Licorice
• Lisinopril
• Moexipril
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Senna
• Sodium Picosulfate
• 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 adjust the dose or how often you use one or both of the medicines.

• Indinavir
• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since 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

Having other medical problems may affect the use of this medicine. Make sure you 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
• History of heart rhythm problems (e.g., prolonged QT interval, uncontrolled arrhythmia) 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 risk for seizures, arrhythmia, or kidney problems.

• Congestive heart failure or
• Dehydration 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—Must be corrected first before starting treatment with 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.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency with an infection, or a history of hemolysis—Use with caution. This medicine contains sodium ascorbate and ascorbic acid which may cause serious unwanted effects in patients with this condition.

• Phenylketonuria—Use with caution. This medicine contains phenylalanine which may cause serious unwanted effects in patients with this condition.

Along with its required effects, a medicine can 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 right away if any of the following side effects happen:

Less common

• Blurred vision
• confusion
• decreased urination
• dizziness
• dry mouth
• fainting
• full or bloated feeling
• headache
• heartburn
• increase in heart rate
• irregular heartbeat
• lightheadedness
• muscle cramps or pain
• nervousness
• numbness, tingling, pain, or weakness in the hands or feet
• pounding in the ears
• pressure in the stomach
• rapid breathing
• seizures
• slow or fast heartbeat
• stomach pain or discomfort
• sunken eyes
• swelling of the stomach area
• thirst
• trembling
• unusual tiredness or weakness
• vomiting
• weakness and heaviness of the legs
• wrinkled skin

Rare

• Chest tightness
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• hives, itching, rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• trouble breathing or swallowing

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, noisy breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• pale skin
• rapid weight gain
• severe stomach pain
• swelling in the legs and ankles
• swelling of the neck
• throat tightness
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• 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. Also, your health care professional may have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Nausea

Less common

• Sore throat
• stuffy or runny nose

Rare

• Discomfort in the anus or rectum
• feeling of warmth
• headache, severe and throbbing
• lack or loss of strength
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness

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.

Pharmacologic Class: Ascorbic Acid

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To prepare the mixture:

• Empty the contents of the packet (Dose 1) into the mixing container.
• Add at least 16 ounces (oz) of water to the fill line. Do not add any other liquid or starch-based thickeners to the medicine.
• Mix with a spoon or put the lid on the container and shake for about 2 to 3 minutes until the mixture is completely dissolved.
• Rinse the mixing container with water and refill it with clear liquids (16 oz) within 30 minutes.
• For Dose 2, repeat the steps for Dose 1, but you should empty the contents of the two dose pouches (A and B) into the mixing container at the same time.

It is best if you do not eat any solid food before taking this medicine and until after your colonoscopy.

You may drink clear liquids (eg, water) up until 2 hours before the time of the test. However, check first with your doctor. Do not eat or drink alcohol, milk, or anything red or purple liquids or foods with pulp.

If you take other medicines, take them at least 1 hour before you start this medicine.

You may take this medicine 2 ways: the One-Day Morning Dosing schedule or the Two-Day Split Dosing schedule.

• One-Day Morning Dosing:You may eat a light breakfast and lunch one day before the procedure. You may also have clear broth soup or plain yogurt for dinner (about 8 PM). You should not eat the morning of your colonoscopy.
• Two-Day Split Dosing:You may eat a light breakfast and lunch one day before the procedure. You should finish eating your lunch at least 3 hours before you start using this medicine.

You should have your first loose stool or mild diarrhea about 1 to 2 hours 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.

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 the bowels: Adults—Your doctor will tell you how to use this medicine, either by the One-Day Morning Dosing option or the Two-Day Split Dosing option. One-Day Morning Dosing: Take the first dose the morning of your colonoscopy (between 3 AM and 7 AM), then the second dose about 2 hours after. You should have taken the second dose at least 2 hours before your colonoscopy. Two-Day Split Dosing: Take the first dose in the evening (between 4 PM and 8 PM), then the second dose 12 hours after. You should have taken the second dose at least 2 hours before your colonoscopy. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

You may store the unopened medicine and the oral liquid at room temperature or in the refrigerator. You may use this medicine within 6 hours after mixing it with water. Throw away any unused oral liquid after 6 hours.