DailyMed Label: SUTAB

DailyMed Label: SUTAB

2023

DailyMed Prescription

SUTAB

sodium sulfate, magnesium sulfate, and potassium chloride

Braintree Laboratories, Inc.

NDC: 52268-201

NDC: 52268-201

NDC: 52268-201

NDC: 52268-201

SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets is an orally administered osmotic laxative and is provided as two bottles, each containing 12 tablets. Each tablet contains: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride. Inactive ingredients include: polyethylene glycol 8000, sodium caprylate, and ethylene glycol and vinyl alcohol graft copolymer. Sodium Sulfate, USP The molecular formula is Na 2 SO 4 . The average molecular weight is 142.04. The structural formula is: Magnesium Sulfate, USP The molecular formula is MgSO 4 . The average molecular weight is 120.37. The structural formula is: Potassium Chloride, USP The molecular formula is KCl. The average molecular weight is 74.55. The structural formula is: Sodium Sulfate Magnesium Sulfate Potassium Chloride

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

For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing information. ( 2.1 , 2.2 ) Preparation and Administration ( 2.1 ) Administration of two doses (24 tablets) are required for a complete preparation for colonoscopy. SUTAB is supplied as two bottles each containing 12 tablets. Twelve (12) tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles the evening prior to the colonoscopy. Must consume water with each dose and an additional 32 ounces of water after each dose. Do not take other laxatives. Administer oral medications at least 1 hour before 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. Recommended Split Dose (2-Day) Regimen ( 2.2 ) Day 1, Dose 1: On the Evening Prior to Colonoscopy Open 1 bottle of 12 tablets. Remove and discard the desiccant. Remove and discard the desiccant from the second bottle and close the bottle. Use the second bottle for the second dose on the morning of the colonoscopy. 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 with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Day 2, Dose 2: Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1): Continue to consume only clear liquids until after the colonoscopy. Repeat Step 2 to Step 4 from Day 1, Dose 1. 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. 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. SUTAB is supplied as two bottles each containing 12 tablets. Twelve (12) tablets are equivalent to one dose. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2 )] . Must consume water with each dose of SUTAB and an additional 32 ounces of water must be consumed after each dose [see Dosage and Administration (2.2) and Warnings and Precautions ( 5.1 )] . 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. Administer oral medications at least 1 hour before 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. The recommended Split-Dose (2-day) dosage 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: 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. Examples of clear liquids are coffee or tea (no cream or non-dairy creamer), fruit juices (without pulp), gelatin desserts (no fruit or topping), water, chicken broth, clear soda (such as ginger ale). Day 1, Dose 1 - On the Evening Prior to Colonoscopy: Early in the evening prior to colonoscopy, open one bottle of 12 tablets. Remove and discard the desiccant. Remove and discard the desiccant from the second bottle and close the bottle. Use the second bottle for the second dose on the morning of the colonoscopy. Fill the provided container with 16 ounces of water (up to the fill line). Swallow one tablet at a time with a sip of water. Finish taking the 12 tablets and drinking the entire amount of water within 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. Day 2, Dose 2 – The Morning of the Colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1): Continue to consume only clear liquids until after the colonoscopy. Repeat Step 2 to Step 4 from Day 1, Dose 1. 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 taking all SUTAB tablets and water at least two hours prior to colonoscopy.

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. Tablets: 1.479 g sodium sulfate, 0.225 g magnesium sulfate, and 0.188 g potassium chloride.

SUTAB is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 ) Bowel Perforation [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 )] Gastrointestinal obstruction or ileus ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Hypersensitivity to any ingredient in SUTAB ( 4 , 5.7 )

Risk of fluid and electrolyte abnormalities : Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 ) Cardiac arrhythmias : Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures : Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. ( 5.3 , 7.1 ) Patients with renal impairment or taking concomitant medications that  affect renal function : Use caution, ensure adequate hydration and consider laboratory testing. ( 5.4 , 7.1 ) Colonic Mucosal ulcerations : Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 ) Suspected GI obstruction or perforation : Rule out the diagnosis before administration. ( 4 , 5.6 ) Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. ( 5.7 ) Risk of Gastrointestinal Complications with Ingestion of Desiccant : Postmarketing reports of ingestion of the desiccant along with SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking. ( 2.2 , 5.8 ) 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 postcolonoscopy 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 )] . 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 predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. 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 )] . 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 postcolonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific  Populations ( 8.6 )] . Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. 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). If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB [see Contraindications ( 4 )] . Use in caution in patients with severe active ulcerative colitis. Serious hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, rash, pruritis and urticaria have been reported with SUTAB [see Adverse Reactions ( 6.2 )] . Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:

Drugs that increase risk of fluid and electrolyte imbalance ( 7.1 ) 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 [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] . SUTAB can reduce the absorption of other co-administered drugs [see Dosage and Administration ( 2.1 )] : 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. Concurrent use of stimulant laxatives and SUTAB may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking SUTAB [see Warnings and Precautions ( 5.5 )] .

Risk Summary 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). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Risk Summary 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. The developmental and health benefits of breastfeeding should be considered 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. Safety and effectiveness in pediatric patients have not been established. Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 )] . Use SUTAB with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warning and Precautions ( 5.4 )] .

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 (NDC 52268-201-01) contains: Two bottles, each bottle (NDC 52268-200-01) contains 12 tablets. One container with a 16-ounce fill line. Note to Pharmacist : Inform the patient to remove and discard the desiccant from both bottles of SUTAB the evening prior to the colonoscopy [see Dosage and Administration ( 2.2 )] 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.

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. Absorption After the oral administration of SUTAB to patients in clinical studies, the median serum sulfate concentration increased by about 2.5-fold at 5 to 8 hours post Dose 2 (0.61 mmol/L) compared to baseline (0.25 mmol/L) and returned to baseline by 24 to 48 hours after colonoscopy. Elimination Fecal excretion is the primary route of sulfate elimination. Use in Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was studied in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min). In patients with moderate renal impairment, mean AUC was 54% higher and mean Cmax was 44% higher than healthy subjects. The mean sulfate concentrations in healthy subjects and in patients with moderate renal impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was approximately 16% lower in patients with moderate renal impairment than in healthy subjects. These differences are not considered clinically meaningful. Patients with Hepatic Impairment The disposition of sulfate after ingestion of a sulfate-based product containing sodium sulfate, potassium sulfate, and magnesium sulfate similar to SUTAB was also studied in patients (N=6) with mild-moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and Cmax) was similar between healthy subjects and patients with hepatic impairment. The mean sulfate concentrations in healthy subjects and in patients with mild to moderate hepatic impairment returned to their respective baselines by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours after the first dose was similar between patients with hepatic impairment and healthy subjects.

Animal toxicology studies with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB) have not been conducted. Sulfate salts of sodium, potassium, and magnesium, were administered orally (gavage) to rats and dogs up to 28 days up to a maximum daily dose of 5 grams/kg/day (approximately 0.9 and 3 times for rats and dogs, respectively, the recommended SUTAB human dose of 45.4 grams/day or 0.86 grams/kg based on the body surface area). In rats, the sulfate salts caused diarrhea and electrolyte and metabolic changes, including hypochloremia, hypokalemia, hyponatremia, lower serum osmolality, and high serum bicarbonate. Significant renal changes included increased fractional sodium excretion, increased urinary sodium and potassium excretion, and alkaline urine in both male and females. In addition, creatinine clearance was significantly decreased in females at the highest dose. No microscopic renal changes were seen. In dogs, the sulfate salts caused emesis, excessive salivation, excessive drinking of water, and abnormal excreta (soft and/or mucoid feces and/or diarrhea) and increased urine pH and sodium excretion.

The colon cleansing efficacy of SUTAB was evaluated in two randomized, single-blind, active-controlled, multicenter trials (Study 1 and Study 2). These trials included adult subjects undergoing colonoscopy for colorectal cancer screening and surveillance, or diagnostic colonoscopy, including subjects with abdominal pain, diarrhea, constipation and non-severe inflammatory bowel disease. In Study 1 (BLI4700-301; NCT 03404401), 548 adult patients were included in the efficacy analysis. Patients ranged in age from 19 to 84 years (median age 59 years) and 56% were female. Racial distribution was 78% Caucasian, 16% African-American, and 11% Hispanic or Latino. Patients were randomized to one of the following two colon preparation regimens: SUTAB or polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution. Both preparations were administered according to a split-dose regimen [see Dosage and Administration ( 2.2 )] . Patients receiving SUTAB were limited to a low residue breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the comparator bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids and/or yogurt for dinner. Approximately 97% of patients in the study completed both doses of preparation (98% of SUTAB patients and 95% of comparator patients). In Study 2 (BLI4700-302; NCT 03261960), 388 adult patients were included in the efficacy analysis. Patients ranged in age from 23 to 83 years (median age 58 years) and 58% were female. Racial distribution was 94% Caucasian, 9% Hispanic or Latino, and 5% African-American. Patients were randomized to one of the following two colon preparation regimens: SUTAB or sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution. Both preparations were administered according to a split-dose regimen [see Dosage and Administration ( 2.2 )] . Patients receiving SUTAB were limited to a low residue breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the comparator bowel prep were only allowed clear liquids on the day prior to colonoscopy. Approximately 98% of patients in the study completed both doses of preparation (98% of SUTAB patients and 99% of comparator patients). The primary efficacy endpoint in each trial was the proportion of patients with successful colon cleansing, as assessed by the blinded colonoscopist utilizing the four-point scaled described below. Success was defined as an overall cleansing assessment of 3 (Good) or 4 (Excellent). Score Grade Description 1 Poor  Large amount of fecal residue, additional bowel preparation required. 2 Fair  Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa. 3 Good  Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa. 4 Excellent  No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa. Results for the primary endpoint in Studies 1 and 2 are shown in Table 3. In both trials, SUTAB was non-inferior to the comparator. Table 3 Proportion of Adult Patients with Overall Cleansing Success a in Two Controlled Trials with a Split-Dose Regimen a Success was defined as an overall cleaning assessment of 3 (Good) or 4 (Excellent) by the blinded endoscopist, scores were assigned on withdrawal of colonoscope. b treatment differences and confidence intervals were adjusted by study sites based on Mantel-Haenszel method c comparator in Study 1 was polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution d comparator in Study 2 was sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution e non-inferior SUTAB % (n/N) Comparator % (n/N) SUTAB-comparator Difference b (%) 99% Confidence Interval b Study 1 92% (257/278) 89% c (241/270) 3.0 (-3.2, 9.3) e Study 2 92% (175/190) 88% d (174/198) 3.1 (-4.5, 10.7) e

Principal Display Panel Carton Label NDC 52268-201-01 Please see www.sebelapharma.com for patent information. SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets 1.479g/0.225g/0.188g NOTE TO PHARMACIST: Inform patients to REMOVE AND DISCARD the DESICCANT from both medication bottles before SUTAB ingestion. This carton contains: 2 Bottles of 12 tablets each 1 16-ounce cup 1 Patient booklet Booklet includes: 1. Instructions for Use 2. Full Prescribing Information 3. Medication Guide Both 12-tablet bottles are required for a complete preparation. ©2020 Braintree Laboratories Inc. All rights reserved. OCT 2023 SUT20101 Rx only Braintree A PART OF SEBELA PHARMACEUTICALS Carton