SUTAB

SUTAB- sodium sulfate, magnesium sulfate anhydrous and potassium chloride tablet
Braintree Laboratories, Inc.

1 INDICATIONS AND USAGE

SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation and Administration Instructions

  • Correct fluid and electrolyte abnormalities before treatment with SUTAB [see Warnings and Precautions ( 5.1)]
  • Administration of two doses of SUTAB (24 tablets) are required for a 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 breakfast on the day before colonoscopy, followed by clear liquids up to 2 hours prior to 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.

2.2 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 colonoscopy:

  • A low residue breakfast may be consumed. Examples of low residue foods are eggs, white bread, cottage cheese, yogurt, grits, coffee, tea.
  • After breakfast, only clear liquids may be consumed until after the colonoscopy.
  • Early in the evening prior to 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 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.
  • The morning of 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 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.
  • Complete all SUTAB tablets and water at least two hours prior to colonoscopy.

3 DOSAGE FORMS AND STRENGTHS

Tablets: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. The tablets are white to off-white, film coated, oblong, and biconvex with flat sides, debossed with S24 on one side.

4 CONTRAINDICATIONS

SUTAB is contraindicated in the following conditions:

  • Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6)
  • Toxic colitis or toxic megacolon
  • Gastric retention
  • Hypersensitivity to any ingredient in SUTAB [see Warnings and Precautions ( 5.7) and Description ( 11)]

5 WARNINGS AND PRECAUTIONS

5.1 Serious Fluid and Electrolyte Abnormalities

Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment. [see Drug Interactions ( 7.1)]

5.2 Cardiac Arrhythmias

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

5.3 Seizures

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions ( 7.1)] .

5.4 Use in Patients with Risk of Renal Injury

Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions ( 7.1)] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations ( 8.6)] .

5.5 Colonic Mucosal Ulcerations and Ischemic Colitis

Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. In addition, gastric ulcerations or gastritis may occur. Concurrent use of stimulant laxatives and SUTAB may increase these risks [see Drug Interactions ( 7.3)] . Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

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