Sodium sulfate, magnesium sulfate, and potassium chloride (oral route)

Brand Name

US Brand Name

Sutab

Description

Sodium sulfate, magnesium sulfate, and potassium chloride 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.

This product is available in the following dosage forms:

Tablet

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 sodium sulfate, magnesium sulfate, and potassium chloride combination 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 sodium sulfate, magnesium sulfate, and potassium chloride combination 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 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.

Alacepril
Amiloride
Baloxavir Marboxil
Benazepril
Bisacodyl
Canrenoate
Captopril
Chlorpromazine
Chlortetracycline
Cilazapril
Ciprofloxacin
Delafloxacin
Delapril
Demeclocycline
Digoxin
Dolutegravir
Doxycycline
Elvitegravir
Enoxacin
Eravacycline
Fosinopril
Gatifloxacin
Gemifloxacin
Grepafloxacin
Hydroxychloroquine
Imidapril
Indomethacin
Iron
Levofloxacin
Levomethadyl
Licorice
Lisinopril
Lomefloxacin
Lymecycline
Meclocycline
Methacycline
Minocycline
Moexipril
Moxifloxacin
Norfloxacin

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.

Proper Use

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 and patient instructions. 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 low-residue breakfast (eg, eggs, white bread, cottage cheese, yogurt, grits, coffee, or tea) on the day before your colonoscopy.

You may drink only clear liquids (eg, coffee or tea without cream or nondairy creamer, fruit juices without pulp, gelatin desserts without fruit or topping, water, chicken broth, clear soda) all day and the next day until 2 hour before your colonoscopy. Do not drink anything colored red or purple. Do not drink milk or alcohol.

To use the Sutab®:

The Sutab® contains 2 bottles (12 tablets each bottle), taken as a 2-day regimen (Split-dose method).
Early in the evening before the colonoscopy, open one bottle of 12 tablets. Remove and throw away the drying agent (desiccant) canister from both bottles. Use the second bottle for the second dose on the morning of the colonoscopy.
Fill the given container with 16 ounces of water (up to the fill line). Swallow 1 tablet at a time with a sip of water and drink the entire amount over 15 to 20 minutes.
One hour after swallowing the last tablet, fill the container for the second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. After 30 minutes, repeat the same step and drink over 30 minutes.
Then, on the morning of colonoscopy (5 to 8 hours before the test and at least 4 hours after the first dose), repeat the same steps and complete all Sutab® tablets and required amount of water at least 2 hours before the test.
If you have nausea, bloating, or cramping, you may pause or slow the rate of drinking the additional water until your symptoms stopped.
Do not eat or drink anything 2 hours prior to your colonoscopy, unless your doctor provides you with different instructions.

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 Sutab®.

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 (tablet):
  - Adults—
    - Dose 1: One bottle (12 tablets) taken early in the evening before colonoscopy.
    - Dose 2: One bottle (12 tablets) taken in the morning of the test, 5 to 8 hours before the colonoscopy.
  - Children—Use and dose must be determined by your doctor.

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.

Each bottle contains a drying agent (desiccant) canister that helps protect the tablets from moisture.

Precautions

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, 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 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 stomach or 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.

This medicine may cause serious allergic reactions (eg, anaphylaxis, angioedema, dyspnea, rash), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have a cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after using this medicine.

This medicine may increase the risk of stomach or bowel problems or choking if drying agent (desiccant) canister is not removed from the bottle.

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:

Rare

Dizziness
fainting
fast, slow, or uneven heartbeat

Incidence not known

Bloody stools
burning feeling in the chest or stomach
chest tightness
confusion
cough
decreased urination
diarrhea
difficulty swallowing
drowsiness
dry mouth
fainting
hives, itching, skin rash
increase in heart rate
indigestion
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
lightheadedness
loss of appetite
mood or mental changes
nausea
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid breathing
rectal bleeding
seizures
stomach pain, tenderness, or upset
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.

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