SUTAB

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. 2.1 Important 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. 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. 2.2 Recommended Split-Dose (2-Day) Dosage Regimen 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.

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 )

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Risk of Gastrointestinal Complications with Ingestion of Desiccant [see Warnings and Precautions ( 5.8 )] Most common gastrointestinal adverse reactions are nausea, abdominal distension, vomiting and upper abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc. at 1-800-874-6756 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. The safety of SUTAB was evaluated in two randomized, parallel group, multicenter, investigator blinded clinical trials in 941 adult patients undergoing colonoscopy. The active comparators were polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate for oral solution in Study 1 and sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution in Study 2 [see Clinical Studies ( 14 )] . Adverse Gastrointestinal Reactions Reported by Symptom Questionnaire In Studies 1 and 2, patients were queried for selected gastrointestinal adverse reactions of stomach cramping (upper abdominal pain), stomach bloating (abdominal distention), nausea and vomiting using a standard questionnaire following completion of study drug and prior to colonoscopy on the day of colonoscopy. Patients reporting selected gastrointestinal symptom(s) rated the intensity as mild, moderate or severe. A total of 52% (287/552) of patients in Study 1 and 52% (202/389) in Study 2 reported at least one selected gastrointestinal adverse reaction when queried using the standard questionnaire. Tables 1 and 2 show results for each gastrointestinal adverse reaction reported by patients using the standard questionnaire, including severity. Table 1: Gastrointestinal Symptoms by Severity a From Symptom Questionnaire in Adult Patients Following Colon Cleansing and Prior to Colonoscopy – Study 1 b a Mild : barely noticeable, does not influence functioning causing no limitations of usual activities; Moderate : makes participant uncomfortable, influences functioning causing some limitations of usual activities; Severe : severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities b Study 1 was not designed to support comparative claims for SUTAB for the adverse reactions reported in this table. c Percentage represents n/N for patients who experienced each gastrointestinal adverse reaction on the symptom questionnaire based on the total number of patients per treatment arm. Symptom SUTAB Polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, ascorbic acid and sodium ascorbate Total Number or Patients per Treatment Arm (N) 281 271 Patients with at Least One Gastrointestinal Adverse Reaction from Symptom Questionnaire 163 124 % Nausea c 48 26 Mild 71 77 Moderate 27 23 Severe 2 0 % Abdominal Distension c,d 29 22 Mild 68 71 Moderate 30 29 Severe 1 0 % Vomiting c 23 5 Mild 48 46 Moderate 52 54 Severe 0 0 % Upper Abdominal Pain c 16 18 Mild 65 71 Moderate 35 29 Severe 0 0 Total Number of Patients per Treatment Arm (N) 281 271 Table 2: Gastrointestinal Symptoms by Severity a From Symptom Questionnaire in Adult Patients Following Colon Cleansing and Prior to Colonoscopy – Study 2 b a Mild : barely noticeable, does not influence functioning causing no limitations of usual activities; Moderate : makes participant uncomfortable, influences functioning causing some limitations of usual activities; Severe : severe discomfort, treatment needed, severe and undesirable, causing inability to carry out usual activities b Study 2 was not designed to support comparative claims for SUTAB for the adverse reactions reported in this table. c Percentage represents n/N for patients who experienced each gastrointestinal adverse reaction on the symptom questionnaire based on the total number of patients per treatment arm. Symptom SUTAB Sodium picosulfate, magnesium oxide, and anhydrous citric acid Total Number or Patients per Treatment Arm (N) 190 199 Patients with at Least One Gastrointestinal Adverse Reaction from Symptom Questionnaire 135 67 % Nausea c 52 18 Mild 74 94 Moderate 20 6 Severe 6 0 % Abdominal Distension c 34 15 Mild 73 69 Moderate 27 31 Severe 0 0 % Vomiting c 16 2 Mild 53 33 Moderate 47 67 Severe 0 0 % Upper Abdominal Pain c 23 13 Mild 82 100 Moderate 16 0 Severe 2 0 Total Number of Patients per Treatment Arm (N) 190 199 Patients with at Least One Gastrointestinal Adverse Reaction from Symptom Questionnaire 135 67 Additional Adverse Reactions Reported in Studies 1 and 2 In addition to the gastrointestinal symptoms reported on the standard questionnaire (Tables 1 and 2), other adverse reactions reported in at least 2% of patients in either treatment arm in Studies 1 and 2 were: dizziness in Study 1 (0% SUTAB and 2% comparator); and hypermagnesemia (2% SUTAB and 2% comparator) and increased liver function test (including ALT, AST and bilirubin) (3% SUTAB and 1% comparator) in Study 2. Laboratory Changes Electrolyte Abnormalities Shifts in serum electrolytes from normal at baseline to above the upper end of normal following study drug on the day of colonoscopy in at least 2% of patients in either treatment arm and at least 2% greater in patients treated with SUTAB than treated with comparator in either Study 1 or Study 2 were: magnesium (27% SUTAB and 5% comparator in Study 1), and serum osmolality (44% SUTAB and 28% comparator in Study 2). These changes were transient and resolved without intervention. Renal Function Parameters Decreases in creatinine clearance and increases in blood urea nitrogen (BUN) were reported in less than 1% of patients in both SUTAB and comparator arms in both trials. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of SUTAB. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal : gastric ulceration, gastritis Hypersensitivity : anaphylaxis, angioedema, dyspnea, rash, pruritus, urticaria [see Warnings and Precautions ( 5.7 )]

Drugs that increase risk of fluid and electrolyte imbalance ( 7.1 ) 7.1 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 [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )] . 7.2 Potential for Reduced Drug Absorption 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. 7.3 Stimulant Laxatives 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 )] .