ColPrep Kit (Oral)

Sodium sulfate, potassium sulfate, and magnesium sulfate combination is used to clean the colon (bowel) before a colonoscopy. This medicine is a laxative. It causes diarrhea to help cleanse your colon. Cleaning your colon helps your doctor see the inside of your colon more clearly during the colonoscopy.

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

It is important that your doctor monitor you closely for any issues that may arise from this medicine. Blood and urine tests may be necessary to check for unwanted effects.

Call your doctor immediately if you experience decreased urination, dizziness, headache, or vomiting. These could be signs of dehydration.

Contact your doctor right away 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, such as QT prolongation.

This medicine may increase your risk of seizures. This risk is higher if you are taking medicine for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have electrolyte imbalances (for example, low sodium, potassium, calcium, or magnesium in the blood). Talk to your doctor if you have any concerns.

Stay hydrated before, during, and after using this medicine. Drink extra fluids to help you pass more urine. This may help prevent kidney problems.

This medicine may cause serious bowel issues (for example, colon ulcers, ischemic colitis). Contact your doctor immediately if you have stomach pain and tenderness, bloody stools, or rectal bleeding.

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, you and your doctor need to think about the risks of taking the medicine compared to the benefits it will provide. Here are some important points to consider:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies done on the effects of Suprep Bowel Prep Kit® in children younger than 12 years. Its safety and effectiveness have not been established.

There have not been appropriate studies done on the effects of ColPrep Kit® in children. Its safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the use of ColPrep Kit® or Suprep Bowel Prep Kit®. However, older patients are more likely to have age-related issues with their liver, kidneys, or heart, and may experience unwanted effects (for example, fluid or electrolyte imbalance), which may require caution when using Suprep Bowel Prep Kit®.

Breast Feeding

There are not enough studies in women to determine the risks to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen 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
• 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 medicines.

• Alacepril
• Amiloride
• Baloxavir Marboxil
• Benazepril
• Bictegravir
• Bisacodyl
• Canrenoate
• Captopril
• Chlorpromazine
• Chlortetracycline
• Cilazapril
• Ciprofloxacin
• Delafloxacin
• Delapril
• Demeclocycline
• Digoxin
• Dolutegravir
• Doxycycline
• Eltrombopag
• Elvitegravir
• Enoxacin
• Eravacycline
• Fosinopril
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Imidapril
• Indomethacin
• Iron
• Levofloxacin
• Levomethadyl
• Licorice
• Lisinopril
• Lomefloxacin
• Lymecycline
• Meclocycline
• Methacycline
• Minocycline
• Moexipril
• Moxifloxacin
• Norfloxacin
• Ofloxacin
• Omadacycline
• Oxytetracycline
• Penicillamine
• Pentopril
• Perindopril
• Quinapril
• Raltegravir
• Ramipril
• Rolitetracycline
• Sarecycline
• Senna
• Sodium Picosulfate
• Sparfloxacin
• Sparsentan
• Spirapril
• Spironolactone
• Temocapril
• Tetracycline
• Tigecycline
• Trandolapril
• Triamterene
• Trovafloxacin
• Zofenopril

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Delafloxacin
• Felodipine
• Isradipine
• Licorice
• Nicardipine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure you inform your doctor about any other medical issues, especially:

• Angina (unstable chest pain) or
• Congestive heart failure or
• Electrolyte imbalance (for example, low calcium, magnesium, potassium, sodium in the blood) or
• Fluid imbalance or
• Recent heart attack or
• Heart disease (for example, cardiomyopathy) or
• History of heart rhythm issues (for example, prolonged QT interval, uncontrolled arrhythmia) or
• Withdrawal from alcohol or benzodiazepines (such as alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—This may increase the risk of seizures, arrhythmia, or kidney issues.

• Dehydration or
• Gout or
• Inflammatory bowel disease or
• Kidney disease or
• History of seizures or
• Trouble swallowing or
• Severe and active ulcerative colitis—Use with caution. This may worsen these conditions.

• Gastric retention (issues with emptying food or fluid from the stomach) or
• Intestinal problems (for example, blockage, ileus, perforation) or
• Toxic colitis or
• Toxic megacolon (a very dilated intestine)—This 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 will happen, but if they do, they may need medical attention.

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

Rare

• Dizziness
• fainting
• fast, slow, or uneven heartbeat

Incidence not known

• Bloody stools
• confusion
• decreased urination
• diarrhea
• drowsiness
• dry mouth
• fainting
• increase in heart rate
• lightheadedness
• loss of appetite
• mood or mental changes
• nausea
• rapid breathing
• rectal bleeding
• seizures
• stomach pain and tenderness
• sunken eyes
• swelling of the eyelids, face, lips, ankles, hands, or feet
• thirst
• trouble breathing
• unusual tiredness or weakness
• vomiting
• wrinkled skin

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 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 or are bothersome or if you have any questions about them:

More common

• Full or bloated feeling
• pressure in the stomach
• swelling of the stomach area

Less common

• Headache

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.

• ColPrep Kit
• Suprep Bowel Prep Kit

Available Dosage Forms:

• Solution

Therapeutic Class: Laxative, Hyperosmotic

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

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

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

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

You may eat a light breakfast or drink clear liquids (eg, water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin without fruit) on the day before your colonoscopy.

You may drink clear liquids (eg, water, apple juice, broth, tea, jello), before, during, and up until 2 hours before the time of your colonoscopy. Do not drink anything colored red or purple. Do not drink milk or alcohol.

To use the ColPrep Kit®:

• The ColPrep Kit® contains 2 bottles of ColPrep®, taken as a 2-day regimen (Split-dose method).
• The powder must be mixed with water before it is used. Open 1 bottle of ColPrep Kit® and add water up to the neck of the bottle.
• Replace cap and shake well and mix thoroughly.
• Pour the mixed solution into the mixing container provided.
• Fill the mixing container with water to up the red 16 ounce fill line.
• Drink all of the liquid in the mixing container.
• Drink 2 more mixing containers filled up to the 16 ounce fill line with water over the next hour (32 ounces of additional water).
• Then, on the morning before the colonoscopy, repeat the same steps and complete all ColPrep Kit® solution and required amount of water at least 2 hours before the test.
• Do not eat or drink anything 2 hours prior to your colonoscopy, unless your doctor provides you with different instructions.

To use the Suprep Bowel Prep Kit®:

• The Suprep Bowel Prep Kit® contains 2 bottles of this medicine, taken as a 2-day regimen (Split-dose method).
• On the evening before the colonoscopy, open 1 bottle of Suprep Bowel Prep Kit® and pour the contents into the mixing container provided.
• Fill the mixing container with cool water up to the 16-ounce fill line for adults or 12-ounce fill line for children.
• Drink all of the liquid in the mixing container.
• Drink 2 more mixing containers filled up to the 16-ounce fill line for adults or 12-ounce fill line for children with water over the next hour (32 ounces for adults or 24 ounces for children of additional water).
• Then, on the morning (10 to 12 hours after the evening dose) before the colonoscopy, repeat the same steps and complete all Suprep Bowel Prep Kit® solution and required amount of water at least 2 hours before the test.

Avoid taking other laxatives (eg, bisacodyl, sodium picosulfate) while you are taking this medicine. Do not take any medicine by mouth within 1 hour before taking this medicine.

If you are taking chlorpromazine (Thorazine®), digoxin (Lanoxin®), iron supplements, penicillamine (Cuprimine®, Depen®), or tetracycline or fluoroquinolone antibiotics, take these medicines at least 2 hours before or 6 hours after taking Suprep Bowel Prep Kit®.

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 the colon: For oral dosage form (oral solution): Adults— Dose 1: One bottle (6 ounces) taken early in the evening before colonoscopy, 10 to 12 hours before the second dose. Dose 2: One bottle (6 ounces) taken in the morning of the test, at least 2 hours before the colonoscopy. Children 12 years of age and older— Dose 1: One bottle (4.5 ounces) taken early in the evening before colonoscopy, 10 to 12 hours before the second dose. Dose 2: One bottle (4.5 ounces) taken in the morning of the test, at least 2 hours before the colonoscopy. Children younger than 12 years of age—Use and dose must be determined by your doctor. For oral dosage form (powder for oral solution): Adults— Dose 1: One bottle taken early in the evening before colonoscopy, 10 to 12 hours before the second dose. Dose 2: One bottle taken in the morning of the test, at least 3.5 hours before the colonoscopy. Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.