Sutab

— THERAPEUTIC CATEGORIES —
  • Constipation and bowel cleansers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Sutab Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sodium sulfate 1.479g, magnesium sulfate 0.225g, potassium chloride 0.188g; per tab.

    Pharmacological Class

    Osmotic laxative.

    How Supplied

    Tabs—24 (w. 16oz container)

    How Supplied

    • Each tablet of Sutab contains 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. 

    • Each carton of Sutab contains: 2 bottles, each bottle contains 12 tablets. One container with a 16-ounce fill line. 

    Storage

    Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature.  

    Manufacturer

    Braintree Laboratories, Inc.

    Generic Availability

    NO

    Mechanism of Action

    The primary mode of action is osmotic action of sodium sulfate and magnesium sulfate, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

    Sutab Indications

    Indications

    Bowel cleansing prior to colonoscopy.

    Sutab Dosage and Administration

    Prior to Treatment Evaluations

    Correct fluid and electrolyte abnormalities.

    Adult

    Split-dose regimen (1st dose start the evening before colonoscopy): 12 tabs with 16oz of water over 15–20mins; approx. 1hr after the last tab is ingested, drink additional 16oz of water over 30mins; then approx. after 30mins, drink another 16oz of water over 30mins; (2nd dose start next morning): repeat on day of colonoscopy 5–8hrs before procedure and no sooner than 4hrs from starting Dose 1. Total regimen: 24 tabs. Complete all tabs and water at least 2hrs before colonoscopy.

    Adult

    Split-Dose (2-Day) Regimen

    The recommended regimen consists of 2 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.

    Dose 1 – On the day prior to colonoscopy:

    • Consume a low residue breakfast – Examples include eggs, white bread, cottage cheese, yogurt, grits, coffee, tea.

    • After breakfast, consume only clear liquids until after the colonoscopy.

    • Early in the evening prior to colonoscopy, open 1 bottle of 12 tablets.

    • Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet and drink the entire amount over 15 to 20 minutes.

    • After 1 hour after the last tablet is taken, fill the container again with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

    • Interrupt or slow the rate of drinking the additional water if patients experience preparation-related symptoms (eg, nausea, bloating, cramping).

    Dose 2 – Day of colonoscopy:

    • Continue to consume only clear liquids until after the colonoscopy.

    • Open the second bottle of 12 tablets the morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1).

    • Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet and drink the entire amount over 15 to 20 minutes.

    • After 1 hour after the last tablet is taken, fill the container again with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

    • After about 30 minutes after finishing the second container of water, fill the container again with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. 

    • Interrupt or slow the rate of drinking the additional water if patients experience preparation-related symptoms (eg, nausea, bloating, cramping).

    • Complete all Sutab tablets and water at least 2 hours prior to colonoscopy.

    Children

    Not established.

    Administration

    Preparation and Administration Instructions

    • Correct fluid and electrolyte abnormalities prior to initiation.

    • A complete preparation for colonoscopy requires 2 doses of Sutab (24 tablets). 12 tablets are equivalent to one dose.

    • Consume water with each dose and after each dose.

    • On the day prior to colonoscopy, consume a low residue breakfast then consume clear liquids up to 2 hours prior to colonoscopy.

    • Avoid drinking milk, eating or drinking anything colored red or purple. 

    • Avoid alcohol. 

    • Avoid other laxatives while taking Sutab.

    • Avoid oral medications within 1 hour of starting each dose of Sutab.

    • Separate by at least 2 hours before and not less than 6 hours after administration when taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine.

    • Discontinue consumption of all fluids at least 2 hours prior to colonoscopy. 

    Sutab Contraindications

    Contraindications

    GI obstruction or ileus. Bowel perforation. Toxic colitis. Toxic megacolon. Gastric retention.

    Sutab Boxed Warnings

    Not Applicable

    Sutab Warnings/Precautions

    Warnings/Precautions

    Maintain adequate hydration. Correct fluid and electrolyte abnormalities before therapy. Renal impairment; monitor baseline and post-colonoscopy electrolytes, creatinine, BUN. History of QT prolongation, uncontrolled arrhythmias, recent MI, unstable angina, CHF, or cardiomyopathy: increased risk of arrhythmias; consider ECGs at pre-dose and post-colonoscopy. History of seizures. Hyponatremia. Inflammatory bowel disease. Colonic mucosal ulcerations. Ischemic colitis. Severe ulcerative colitis. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Serious Fluid and Electrolyte Abnormalities 

    • Advise patients to hydrate before, during, and after using Sutab.

    • Consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) if significant vomiting or signs of dehydration develop.

    • Correct fluid and electrolyte abnormalities prior to treatment.

    • Exercise caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances and may increase the risk for adverse events of seizure, arrhythmias, and renal impairment.

    Cardiac Arrhythmias

    • Rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation have occurred.

    • Use caution in patients at increased risk for arrhthymias (eg, history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy).

    • For patients at increased risk for serious cardiac arrhthymias, consider pre-dose and post-colonoscopy ECG.

    Seizures

    • 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 have occurred.

    • Exercise caution in patients with a history of seizures and in patients at increased risk of seizure (eg, concomitant use with medications that lower the seizure threshold [eg, tricyclics]), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

    Use in Patients with Risk of Renal Injury 

    • Exercise caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (eg, diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at risk for renal injury.

    • Advise these patients to adequately hydrate with Sutab.

    Colonic Mucosal Ulcerations and Ischemic Colitis

    • Colonic mucosal aphthous ulcerations may occur, along with more serious cases of ischemic colitis requiring hospitalization. Increased risk for these reactions with concomitant use of stimulant laxatives with Sutab.

    • Exercise caution in patients with known or suspected inflammatory bowel disease (IBD).

    Use in Patients with Significant Gastrointestinal Disease

    • Perform appropriate diagnostic studies if GI obstruction or perforation is suspected.

    • Use caution in patients with severe active ulcerative colitis.

    Hypersensitivity Reactions  

    • Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritus, and urticaria have been reported.

    • Seek immediate medical care if signs and symptoms of anaphylaxis develop.

    Pregnancy Considerations

    Risk Summary

    • No available data on the use of Sutab in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

    Nursing Mother Considerations

    Risk Summary

    • No available data on the presence of Sutab in human or animal milk, the effects on the breastfed child, or the effects on milk production.  

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Sutab and any potential adverse effects on the breastfed child from Sutab or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness have not been established.

    Renal Impairment Considerations

    • Use caution in patients with renal impairment or concomitant use with medications that affect renal function.

    • Advise patients to adequately hydrate prior to, during, and after use of Sutab.

    Sutab Pharmacokinetics

    Elimination

    Fecal.

    Sutab Interactions

    Interactions

    Caution with concomitant diuretics, ACE inhibitors, ARBs, NSAIDs; may affect renal function. Drugs that may lower the seizure threshold (eg, tricyclic antidepressants), alcohol or benzodiazepine withdrawal: may increase risk of seizures. Caution with drugs that may increase risk for fluid or electrolyte disturbances, arrhythmias or QT prolongation. Administer oral medications at least 1hr before starting each dose of Sutab. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2hrs before and not less than 6hrs after Sutab to avoid chelation with magnesium. Avoid concomitant stimulant laxatives (eg, bisacodyl, sodium picosulfate).

    Sutab Adverse Reactions

    Adverse Reactions

    Nausea, abdominal distension, vomiting, upper abdominal pain; electrolyte abnormalities, renal injury.

    Sutab Clinical Trials

    Clinical Trials

    • The approval of Sutab was based on 2 active-controlled trials that included adults undergoing colonoscopy for colorectal cancer screening and surveillance or diagnostic colonoscopy. Both Sutab and the active comparators were administered according to a split-dose regimen.

    • The primary endpoint of both trials was the proportion of patients with successful colon cleansing, as assessed by the blinded colonoscopist utilizing a 4-point scale. Success was defined as an overall cleansing assessment of “good” (feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa) or “excellent” (no more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa).

    • In both studies, Sutab was noninferior to the comparator. 

    • 92% of patients (Study 1: 257/278; Study 2: 175/190) achieved overall cleansing success vs 89% of patients (241/270) who received polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution (active comparator in Study 1) and 88% of patients (174/198) of patients who received sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution (active comparator in Study 2).

    Sutab Note

    Not Applicable

    Sutab Patient Counseling

    Patient Counseling

    • A complete preparation for colonoscopy requires 2 doses of Sutab (24 tablets). 12 tablets are equivalent to one dose.

    • Consume water with each dose and after each dose.

    • On the day prior to colonoscopy, consume a low residue breakfast then consume clear liquids up to 2 hours prior to colonoscopy.

    • Interrupt or slow the rate of drinking the additional water if preparation-related symptoms occur (eg, nausea, bloating, cramping).

    • Avoid drinking milk, eating or drinking anything colored red or purple. 

    • Avoid alcohol. 

    • Avoid other laxatives while taking Sutab.

    • Avoid oral medications within 1 hour of starting each dose of Sutab.

    • Separate by at least 2 hours before and not less than 6 hours after administration when taking tetracycline or fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, or penicillamine.

    • Discontinue consumption of all fluids at least 2 hours prior to colonoscopy. 

    • Contact your healthcare provider if significant vomiting or signs of dehydration after taking Sutab occur or if cardiac arrhythmias or seizures occur.

    Cost Savings Program

    Sutab Savings Copay Card

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