Sutab (sodium sulfate, magnesium sulfate, and potassium chloride)

Sutab is a prescription medicine used by adults to clean the colon before a colonoscopy. Sutab works as a laxative by cleaning your colon after causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if Sutab is safe and effective in children.

Sutab can cause serious side effects, including:

• Changes in certain blood tests. Your healthcare provider may do blood tests after you take Sutab to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • dizziness
  • urinate less than usual
  • trouble drinking clear liquid
  • nausea
  • stomach (abdominal) cramping
  • bloating
  • headache
• Heart problems. Sutab may cause abnormal heartbeats.
• Seizures.
• Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding.

The most common side effects of Sutab include:

• nausea
• stomach-area swelling (abdominal distention)
• vomiting
• upper abdominal pain

These are not all the possible side effects of Sutab.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Preparation And Administration Instructions

• Correct fluid and electrolyte abnormalities before treatment with Sutab
• Administration of two doses of Sutab (24 tablets) is required for complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose.
• Water must be consumed with each dose of Sutab and additional water must be consumed after each dose.
• Consume a low-residue break fast on the day before the colonoscopy, followed by clear liquids up to 2 hours prior to the colonoscopy.
• Do not drink milk or eat or drink anything colored red or purple.
• Do not drink alcohol.
• Do not take other laxatives while taking Sutab.
• Do not take oral medications within 1 hour of starting each dose of Sutab.
• If taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine, take these medications at least 2 hours before and not less than 6 hours after administration of each dose of Sutab.
• Stop consumption of all fluids at least 2 hours prior to the colonoscopy.

Split-Dose (2-Day) Regimen

The recommended Split-Dose regimen for adults consists of two doses of Sutab: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy.

Instruct Patients

Dose 1 — On the day prior to the colonoscopy

• A low-residue breakfast may be consumed. Examples of low-residue foods are eggs, white bread, cottage cheese, yogurt, grits, coffee, and tea.
• After breakfast, only clear liquids may be consumed until after the colonoscopy.
• Early in the evening prior to the colonoscopy, open one bottle of 12 tablets.
• Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet with a sip of water and drink the entire amount for over 15 to 20 minutes.
• Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.
• Approximately 30 minutes after finishing the second container of water, fill the provided container again with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.
• If patients experience preparation-related symptoms (e.g. nausea, bloating, cramping), pause or slow the rate of drinking the additional water until symptoms diminish.

Dose 2 — Day of Colonoscopy

• Continue to consume only clear liquids until after the colonoscopy.
• On the morning of the colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1), open the second bottle of 12 tablets.
• Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet with a sip of water and drink the entire amount for over 15 to 20 minutes.
• Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16ounces of water (up to the fill line) and drink the entire amount over 30 minutes.
• Approximately 30 minutes after finishing the second container of water, fill the provided container again with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.
• If patients experience preparation-related symptoms (e.g. nausea, bloating, cramping), pause or slow the rate of drinking the additional water until symptoms diminish.
• Complete all Sutab tablets and water at least two hours prior to colonoscopy.

Drugs That May Increase Risks Of Fluid And Electrolyte Abnormalities

Use caution when prescribing Sutab to patients taking medications that increase the risk of fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities.

Potential For Reduced Drug Absorption

Sutab can reduce the absorption of other co-administered drugs:

• Administer oral medications at least one hour before starting each dose of Sutab.
• Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of Sutab to avoid chelation with magnesium.

Stimulant Laxatives

Concurrent use of stimulant laxatives and Sutab may increase the risk of mucosal ulceration or ischemic colitis. Avoid the use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Sutab.

• There are no available data on Sutab use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (Sutab).
• There are no available data on the presence of Sutab in human or animal milk, the effects of on the breastfed child, or the effects on milk production.