Sodium sulfate, magnesium sulfate, and potassium chloride (Oral)

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

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

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

Call your doctor immediately if you experience decreased urination, dizziness, headache, or vomiting. These may be signs of losing too much body fluid (dehydration).

Contact your doctor right away if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you may have a fast, pounding, or uneven heartbeat. Let your doctor know if you have a history of heart rhythm problems, including QT prolongation.

This medicine may increase your risk of seizures. This risk is higher if you are taking medication for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have electrolyte imbalances (e.g., 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, which may help prevent kidney issues.

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

This medicine may cause severe allergic reactions (e.g., anaphylaxis, angioedema, dyspnea, rash), which can be life-threatening and require immediate medical attention. Reach out to your doctor right away if you or your child experience a cough, difficulty swallowing, dizziness, rapid heartbeat, large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genital area, rash, itching, trouble breathing, or unusual tiredness or weakness after using this medicine.

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

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies to understand how sodium sulfate, magnesium sulfate, and potassium chloride combination affects children. We do not know if it is safe or effective for this age group.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the use of sodium sulfate, magnesium sulfate, and potassium chloride combination. However, older patients are more likely to have age-related issues with their liver, kidneys, or heart, and may experience unwanted effects (like fluid or electrolyte imbalance), which could require caution when using this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. You should consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be taken together. In other cases, two different medicines can be used together, even if there may be an interaction. Your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are chosen based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide to change your treatment.

• 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 frequency for 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 may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Delafloxacin
• Felodipine
• Isradipine
• Licorice
• Nicardipine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food, or with certain types of food, due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Angina (unstable chest pain) or
• Congestive heart failure or
• Electrolyte imbalance (like low calcium, magnesium, potassium, or sodium in the blood) or
• Recent heart attack or
• Heart disease (like cardiomyopathy) or
• History of heart rhythm problems (like prolonged QT interval, uncontrolled arrhythmia) or
• Withdrawal from alcohol or benzodiazepines—May increase the risk for seizures, arrhythmia, or kidney problems.

• 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.

• Gastric retention (issues emptying food or fluid from the stomach) or
• Stomach or bowel issues (like blockage, ileus, perforation) or
• Toxic colitis or megacolon (very dilated intestine)—Should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may require 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. Your health care professional may also be able to tell you how 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.

In the U.S.

• Sutab

Available Dosage Forms:

• Tablet

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 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.