Pronunciation:

SOE-dee-um SUL-fate, poe-TAS-ee-um SUL-fate, mag-NEE-zee-um SUL-fate

Brand Names:

• ColPrep Kit
• Suprep Bowel Prep Kit

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Laxative, Hyperosmotic

Uses of This Medicine:

Sodium sulfate, potassium sulfate, and magnesium sulfate combination is used to cleanse the colon (bowel) before a colonoscopy. This medicine 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:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Suprep Bowel Prep Kit® in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of ColPrep Kit® in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ColPrep Kit® or Suprep Bowel Prep Kit® in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, and unwanted effects (eg, fluid or electrolyte imbalance), which may require caution in patients receiving Suprep Bowel Prep Kit®.

Breast-feeding—

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.

Other medicines—

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.

• Eplerenone
• Fesoterodine
• Trospium

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.

• 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 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.

• Delafloxacin
• Felodipine
• Isradipine
• Licorice
• Nicardipine

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
• Congestive heart failure or
• Electrolyte imbalance (eg, low calcium, magnesium, potassium, sodium in the blood) or
• Fluid imbalance or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, prolonged QT interval, uncontrolled arrhythmia), history of or
• Withdrawal from alcohol or benzodiazepines (eg, alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—May increase risk for seizures, arrhythmia, or kidney problems.

• Dehydration or
• Gout 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.

• Gastric retention (problems with emptying of food or fluid from the stomach) or
• Intestinal problems (eg, blockage, ileus, perforation) or
• Toxic colitis or
• Toxic megacolon (a very dilated intestine)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is important that your doctor check you closely for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Call 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, such as 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 electrolyte imbalances (eg, low sodium, potassium, calcium, or magnesium in the blood). Talk to your doctor if you have any concerns.

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 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.

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 of This Medicine:

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:

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 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

Full or bloated feeling

pressure in the stomach

swelling of the stomach area

Less common

Headache

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.