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SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Read time: 4 mins
Marketing start date: 24 Jul 2024

Summary of product characteristics


Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions are: Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) Pediatric Patients (>10%): nausea, abdominal pain, abdominal bloating and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in 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 )] Aspiration [see Warnings and Precautions ( 5.7 )] 6.1 Clinical Studies 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. Adults The safety of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was evaluated in a multi-center, randomized, active controlled trial in 379 adult patients undergoing colonoscopy [see Clinical Studies ( 14 )] . Most Common Adverse Reactions Table 1 shows the most common adverse reactions reported in at least 2% of patients receiving Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or the control (a bowel prep containing polyethylene glycol and electrolytes (PEG + E)) administered in split-dose (2-day) regimens. Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial * reported in at least 2% of patients Symptom Split-Dose (2-Day) Regimen Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution % N=190 PEG + E product % N=189 Overall Discomfort 54 67 Abdominal Distension 40 52 Abdominal Pain 36 43 Nausea 36 33 Vomiting 8 4 Laboratory Abnormalities Table 2 shows the most common laboratory abnormalities (at least 10% in either treatment group and more than 2% difference between groups) for patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or PEG+E administered as a split-dose (2-day) regimen. Table 2: Adult Patients with Normal Baseline Serum Chemistry with A Shift to an Abnormal Value While on the Split-Dose (2-Day) Regimen 1 1 The study was not designed to support comparative claims for the laboratory abnormalities reported in this table. 2 Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the timepoint(s) of interest. Day of Colonoscopy N (%) 2 Day 30 N (%) 2 Bicarbonate (low) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 20 (13) 7 (4) PEG + Electrolytes 24 (15) 4 (3) Bilirubin, total (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 14 (9) 0 (0) PEG + Electrolytes 20 (12) 3 (2) BUN (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 2 (2) 14 (11) PEG + Electrolytes 4 (3) 19 (15) Calcium (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 16 (10) 8 (5) PEG + Electrolytes 6 (4) 6 (4) Chloride (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 4 (2) 6 (4) PEG + Electrolytes 20 (12) 6 (4) Osmolality (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 8 (6) NA PEG + Electrolytes 19 (13) NA Uric acid (high) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 27 (24) 13 (12) PEG + Electrolytes 12 (10) 20 (17) Less Common Adverse Reactions AV Block (1 case) and CK increase. Adverse Reactions with Unapproved Use In another study of 408 adult patients, higher rates of the following adverse reactions and laboratory abnormalities were reported in patients treated with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution as an evening-only (1-day) regimen compared to the split-dose (2-day) regimen. overall discomfort, abdominal distention, nausea, and vomiting total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) Administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in an evening-only (1-day) dosing regimen is not recommended. Pediatrics 12 Years to 16 Years of Age The safety of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was evaluated in a single dose-ranging clinical trial of 89 pediatric patients aged 12 years to 16 years [see Clinical Studies ( 14 )] . In 26 pediatric patients who received Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses), the most common adverse reactions (> 10%) were nausea, abdominal pain, abdominal bloating, and vomiting.

Contraindications

4 CONTRAINDICATIONS Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precaution ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 ( 4 )

Description

11 DESCRIPTION Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) is an osmotic laxative and is provided as two bottles each containing 4.5 ounces of solution. Each bottle contains: 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. Inactive ingredients include: citric acid USP, flavoring ingredients, malic acid FCC, sodium benzoate, NF, sucralose, purified water, USP. Sodium Sulfate, USP The chemical name is Na 2 SO 4 . The average Molecular Weight is 142.04. The structural formula is: Potassium Sulfate, FCC, purified The chemical name is K 2 SO 4 . The average Molecular Weight is 174.26. The structural formula is: Magnesium Sulfate, USP The chemical name is MgSO 4 . The average Molecular Weight: 120.37. The structural formula is: Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution also contains a polypropylene mixing container. Sodium Sulfate Potassium Sulfate Magnesium Sulfate

Dosage And Administration

2 DOSAGE AND ADMINISTRATION Preparation and Administration ( 2.2 ) Must dilute in water prior to ingestion. Administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is required for a complete preparation for colonoscopy. One bottle is equivalent to one dose. Must consume additional water after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. Recommended Dosage and Administration Split-Dose (two-day) regimen consists of two doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: first dose during the evening prior to colonoscopy and second dose the next day, during the morning of colonoscopy. ( 2.1 , 2.3 , 2.4 ) Recommended Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution dosage is: º Adults: Two 6-ounce doses. ( 2.3 ) º Pediatric Patients 12 Years of Age and Older: Two 4.5-ounce doses. ( 2.4 ) For complete information on preparation before colonoscopy and administration of the dosage regimen, see full prescribing Information. ( 2.1 , 2.2 , 2.3 , 2.4 ) 2.1 Dosage and Adminstration Overview Administration of two bottles of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and additional water is required for a complete preparation for colonoscopy. One bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is equivalent to one dose. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is supplied in two dosage strengths [see Dosage Forms and Strengths ( 3 )] . The recommended dosage is: • Adults: Two 6-ounce doses [see Dosage and Administration ( 2.3 )] . • Pediatric patients 12 years of age and older: Two 4.5-ounce doses [see Dosage and Administration ( 2.4 )] . 2.2 Important Preparation and Administration Instructions Correct fluid and electrolyte abnormalities before treatment with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.1 )] Must dilute Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in water before ingestion. Must consume additional water after each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol. Do not take other laxatives while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Do not take oral medications within one hour of starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Drug Interactions ( 7.2 )] . Stop consumption of all fluids at least 2 hours prior to the colonoscopy. 2.3 Recommended Dosage and Administration for Adults The recommended Split-Dose (two-day) regimen for adults consists of two 6-ounce doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts. The following are recommended dosage and administration instructions for adults: Dose 1 – On the Day Prior to Colonoscopy: May consume a light breakfast, or only clear liquids (no solid food). In the evening before the procedure, pour the contents of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 16-ounce fill line over the next hour. Dose 2 - Day of Colonoscopy: Continue to consume only clear liquids. In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. Add cool drinking water to the 16-ounce fill line on the container, mix, and drink the entire amount. Drink two additional containers filled with water to the 16-ounce fill line over the next hour. Complete all solution of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and required water at least two hours prior to colonoscopy. 2.4 Recommended Dosage and Administration for Pediatric Patients 12 Years of Age and Older The recommended Split-Dose (two-day) regimen for pediatric patients 12 years of age and older consists of two 4.5-ounce doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: the first dose during the evening prior to colonoscopy and the second dose the next day, during the morning of the colonoscopy. Each dose consists of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution with additional water. The total volume of liquid required for colon cleansing (using two bottles) is 2.25 quarts. The following are recommended dosage and administration instructions for pediatric patients 12 years of age and older and/or their caregivers: Dose 1 – On the Day Prior to Colonoscopy: • May consume a light breakfast, or only clear liquids (no solid food). • In the evening before the procedure, pour the contents of one bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. • Add cool drinking water to the 12-ounce fill line on the container, mix, and drink the entire amount. • Drink two additional containers filled with water to the 12-ounce fill line over the next hour. Dose 2 – Day of Colonoscopy: • Continue to consume only clear liquids. • In the morning (10 to 12 hours after the evening dose) on the day of the procedure, pour the contents of the second bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution into the mixing container provided. • Add cool drinking water to the 12-ounce fill line on the container, mix, and drink the entire amount. • Drink two additional containers filled with water to the 12-ounce fill line over the next hour. • Complete all solution of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and required water at least two hours prior to colonoscopy.

Indications And Usage

1 INDICATIONS AND USAGE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adult and pediatric patients 12 years of age and older. ( 1 )

Overdosage

10 OVERDOSAGE Overdosage of more than the recommended dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may lead to severe electrolyte disturbances, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

Adverse Reactions Table

Table 1: Common Adverse Reactions* in Adult Patients Undergoing Colonoscopy in a Randomized, Active Controlled Trial

* reported in at least 2% of patients

SymptomSplit-Dose (2-Day) Regimen

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution

% N=190

PEG + E product

% N=189

Overall Discomfort5467
Abdominal Distension4052
Abdominal Pain3643
Nausea3633
Vomiting84

Drug Interactions

7 DRUG INTERACTIONS 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to avoid chelation with magnesium. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Warnings and Precautions ( 5.5 )] .

Clinical Pharmacology

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract. 12.2 Pharmacodynamics No formal pharmacodynamic studies have been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. 12.3 Pharmacokinetics Absorption and Elimination After administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in six healthy subjects, the time at which serum sulfate reached its highest point (T max ) was approximately 17 hours after the first dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours. Excretion Fecal excretion was the primary route of sulfate elimination. Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 C max 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was studied in patients (N=6) with mild to moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and C max ) 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.

Mechanism Of Action

12.1 Mechanism of Action Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract.

Pharmacodynamics

12.2 Pharmacodynamics No formal pharmacodynamic studies have been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

Pharmacokinetics

12.3 Pharmacokinetics Absorption and Elimination After administration of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in six healthy subjects, the time at which serum sulfate reached its highest point (T max ) was approximately 17 hours after the first dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours. Excretion Fecal excretion was the primary route of sulfate elimination. Specific Populations Patients with Renal Impairment The disposition of sulfate after ingestion of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 C max 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was studied in patients (N=6) with mild to moderate hepatic impairment (Child-Pugh grades A and B). Systemic exposure of serum sulfate (AUC and C max ) 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.

Effective Time

20220705

Version

1

Dosage Forms And Strengths

3 DOSAGE FORMS AND STRENGTHS Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5 ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) : Two bottles each containing 6 ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate. ( 3 ) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) : Two bottles each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate. ( 3 )

Spl Product Data Elements

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE sodium sulfate, potassium sulfate, magnesium sulfate SODIUM BENZOATE SUCRALOSE MALIC ACID CITRIC ACID MONOHYDRATE SODIUM SULFATE SODIUM CATION POTASSIUM SULFATE POTASSIUM CATION MAGNESIUM SULFATE, UNSPECIFIED FORM MAGNESIUM CATION BERRY SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE sodium sulfate, potassium sulfate, magnesium sulfate SODIUM BENZOATE SUCRALOSE MALIC ACID CITRIC ACID MONOHYDRATE SODIUM SULFATE SODIUM CATION POTASSIUM SULFATE POTASSIUM CATION MAGNESIUM SULFATE, UNSPECIFIED FORM MAGNESIUM CATION BERRY

Animal Pharmacology And Or Toxicology

13.2 Animal Toxicology and/or Pharmacology The sulfate salts of sodium, potassium, and magnesium contained in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 human dose of 44 grams/day or 0.89 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 males 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.

Nonclinical Toxicology

13 NONCLINICAL TOXICOLOGY 13.2 Animal Toxicology and/or Pharmacology The sulfate salts of sodium, potassium, and magnesium contained in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 human dose of 44 grams/day or 0.89 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 males 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.

Application Number

NDA022372

Brand Name

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Generic Name

sodium sulfate, potassium sulfate, magnesium sulfate

Product Ndc

10572-012

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

Principal Display Panel – Adult Carton Label NDC 10572-012-01 U.S. Patent 6,946,149 Dispense the enclosed Medication Guide to each patient. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution For Adults (17.5g/3.13g/1.6g) per 6 ounces This carton contains: 2 6-ounce (177 mL) bottles of liquid bowel prep 1 16-ounce mixing container 1 Patient booklet. Booklet includes: 1- Medication Guide 2- Patient Instructions 3- Full Prescribing Information R ecommended Dosage: See prescribing information Dilute the solution concentrate as directed prior to use. Both 6-ounce bottles are required for a complete prep. Rx only Affordable Pharmaceuticals, LLC Adult Carton Label

Recent Major Changes

Indications and Usage ( 1 ) 8/2020 Dosage and Administration ( 2.1 , 2.4 ) 8/2020

Recent Major Changes Table

Indications and Usage ( 1) 8/2020
Dosage and Administration ( 2.1, 2.4) 8/2020

Information For Patients

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Instruct patients or caregivers: Must dilute Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution before ingestion. Must consume additional water after each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. On the day before colonoscopy, consume only a light breakfast or clear liquids (e.g., water, apple or orange juice without pulp, lemonade, coffee, tea, or chicken broth). On the day of the colonoscopy only consume clear liquids up to two hours prior to colonoscopy. Two doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution are required for a complete preparation for colonoscopy. One bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is equivalent to one dose. Do not to take other laxatives while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Do not eat solid food or drink milk or eat or drink anything colored red or purple. Do not drink alcohol. Do not take oral medications within one hour of starting each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution [see Drug Interactions ( 7.2 )] . Stop consumption of all fluids at least 2 hours prior to colonoscopy. Contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or if they experience cardiac arrhythmias or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Distributed by Affordable Pharmaceuticals, LLC Braintree, MA 02185 U.S. Patent 6,946,149

Spl Medguide

MEDICATION GUIDE Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (so-DEE-um sul-fate, po-TASS ee-um sul-fate and mag-NEE-see-um sul-fate) Read and understand this Medication Guide instructions at least 2 days before your colonoscopy and again before you start taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and other bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: • abnormal heartbeats that can cause death • seizures. This can happen even if you have never had a seizure. • kidney problems Your chance of having fluid loss and changes in body salts with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is higher if you: • have heart problems • have kidney problems • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: o vomiting o urinating less often than normal o dizziness o headache See "What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?" for more information about side effects. What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution cleans your colon by 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is safe and effective in children under 12 years of age. Do not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction) • an opening in the wall of your stomach or intestine (bowel perforation) • a very dilated intestine (toxic megacolon) • problems with the emptying of food and fluid from your stomach (gastric retention) • an allergy to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution See the end of this Medication Guide for a complete list of ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Before taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, tell your healthcare provider about all of your medical conditions, including if you: • have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). • have gout • have heart problems including an irregular heartbeat, especially a condition called "QT prolongation". • have a history of seizures or take medicines for seizures. • are withdrawing from drinking alcohol or from taking benzodiazepines. • have a low blood salt (sodium) level. • have kidney problems or take medicines for kidney problems. • have stomach or bowel problems including ulcerative colitis. • have problems with swallowing or gastric reflux. • are pregnant or plan to become pregnant. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution will harm your unborn baby. Talk to your healthcare provider if you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Especially tell your healthcare provider if you take: • medicines for blood pressure or heart problems. • medicines for kidney problems. • medicines for seizures. • water pills (diuretics). • non-steroidal anti-inflammatory medicines (pain medicines). • medicines for depression or mental health problems. • laxatives. Do not take other laxatives while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. The following medicines should be taken at least 2 hours before starting Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and not less than 6 hours after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: • tetracycline • fluoroquinolone antibiotics • iron • digoxin (Lanoxin) • chloropromazine • penicillamine (Cuprimine. Depen) Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? See the Instructions for Use in the Patient Instructions for Use Booklet for dosing instructions. You must read, understand, and follow these instructions to take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution the right way. • Take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution exactly as your healthcare provider tells you to take it. • Each bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution must be mixed with water (diluted) before drinking. • It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss (dehydration). • One bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is equal to one dose. • Two doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution are required for complete colonoscopy preparation. • All people taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should follow these general instructions starting 1 day before your colonoscopy: • eat only a light breakfast or clear liquids (for example: water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit) on the day before your procedure. • only drink clear liquids the rest of the day and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2 hours before your colonoscopy. • after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better. • While taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, do not: • take any other laxatives. • take any medicines by mouth (oral) within 1 hour of starting Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. • eat solid foods, drink dairy (such as milk), or drink alcohol while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and until after your colonoscopy • eat or drink anything colored red or purple. Contact your healthcare provider right away if after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution you have severe vomiting, signs of dehydration, changes in consciousness such as feeling confused, delirious or fainting (loss of consciousness) or seizures after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause serious side effects, including: • See " What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?" • Changes in certain blood tests. Your healthcare provider may do blood tests after you takeSodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: o vomiting o nausea o bloating o dizziness o stomach area (abdomen) cramping o headache o urinate less than usual o trouble drinking clear liquid o trouble swallowing o seizures o heart problems o worsening gout • Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding. The most common side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in adults include: o overall discomfort o stomach bloating o stomach pain o nausea o vomiting The most common side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in children 12 to 16 years of age include: o nausea o stomach pain o stomach bloating o vomiting These are not all the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? • Store Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution at room temperature, between 68°F to 77°F (20°C to 25°C). Keep Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and all medicines out of the reach of children. General information about the safe and effective use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for a condition for which it was not prescribed. Do not give Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to other people, even if they are going to have the same procedure you are. It may harm them. You can ask your pharmacist or healthcare provider for information about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution that is written for healthcare professionals. What are the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution? Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is supplied in two dosage strengths. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution comes in a carton containing two 6-ounce bottles, along with a 16-ounce polypropylene mixing container. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Pediatric Oral Solution comes in a carton containing two bottles containing 4.5 ounces of oral solution, along with a 12-ounce polypropylene mixing container. Each bottle contains: Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate. Inactive ingredients: citric acid, USP, flavoring ingredients, malic acid, FCC, sodium benzoate, NF, sucralose, purified water, USP. Distributed by Affordable Pharmacuticals, LLC Braintree, MA 02185, USA For more information go to www.affordablepharma.com or call 1-800-514-5617. This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 08/2020

Spl Medguide Table

MEDICATION GUIDE

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (so-DEE-um sul-fate, po-TASS ee-um sul-fate and mag-NEE-see-um sul-fate)

Read and understand this Medication Guide instructions at least 2 days before your colonoscopy and again before you start taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and other bowel preparations can cause serious side effects, including:

  • Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: • abnormal heartbeats that can cause death • seizures. This can happen even if you have never had a seizure. • kidney problems
  • Your chance of having fluid loss and changes in body salts with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is higher if you:

    • have heart problems

    • have kidney problems

    • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

    Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution:

    o vomiting o urinating less often than normal o dizziness o headache

    See "What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?" for more information about side effects.

    What is Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

    Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is a prescription medicine used by adults and children 12 years of age and older to clean the colon before a colonoscopy. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution cleans your colon by 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is safe and effective in children under 12 years of age.

    Do not take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution if your healthcare provider has told you that you have: • a blockage in your intestine (bowel obstruction) • an opening in the wall of your stomach or intestine (bowel perforation) • a very dilated intestine (toxic megacolon) • problems with the emptying of food and fluid from your stomach (gastric retention) • an allergy to any of the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution See the end of this Medication Guide for a complete list of ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

    Before taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, tell your healthcare provider about all of your medical conditions, including if you:

    • have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes). • have gout • have heart problems including an irregular heartbeat, especially a condition called "QT prolongation". • have a history of seizures or take medicines for seizures. • are withdrawing from drinking alcohol or from taking benzodiazepines. • have a low blood salt (sodium) level. • have kidney problems or take medicines for kidney problems. • have stomach or bowel problems including ulcerative colitis. • have problems with swallowing or gastric reflux. • are pregnant or plan to become pregnant. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution will harm your unborn baby. Talk to your healthcare provider if you are pregnant.

    • are breastfeeding or plan to breastfeed. It is not known if Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution passes into your breast milk. You and your healthcare provider should decide if you will take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution while breastfeeding.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

    Especially tell your healthcare provider if you take: • medicines for blood pressure or heart problems. • medicines for kidney problems. • medicines for seizures. • water pills (diuretics). • non-steroidal anti-inflammatory medicines (pain medicines). • medicines for depression or mental health problems. • laxatives. Do not take other laxatives while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

    The following medicines should be taken at least 2 hours before starting Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and not less than 6 hours after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution: • tetracycline • fluoroquinolone antibiotics • iron • digoxin (Lanoxin) • chloropromazine • penicillamine (Cuprimine. Depen)

    Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

    Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

    How should I take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

    See the Instructions for Use in the Patient Instructions for Use Booklet for dosing instructions. You must read, understand, and follow these instructions to take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution the right way.

    • Take Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution exactly as your healthcare provider tells you to take it. • Each bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution must be mixed with water (diluted) before drinking. • It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss (dehydration). • One bottle of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is equal to one dose. • Two doses of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution are required for complete colonoscopy preparation. • All people taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution should follow these general instructions starting 1 day before your colonoscopy: • eat only a light breakfast or clear liquids (for example: water, strained fruit juice without pulp, lemonade, plain coffee or tea, chicken broth, gelatin dessert without fruit) on the day before your procedure. • only drink clear liquids the rest of the day and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2 hours before your colonoscopy. • after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better.

    While taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, do not:

    • take any other laxatives. • take any medicines by mouth (oral) within 1 hour of starting Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. • eat solid foods, drink dairy (such as milk), or drink alcohol while taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and until after your colonoscopy • eat or drink anything colored red or purple.

    Contact your healthcare provider right away if after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution you have severe vomiting, signs of dehydration, changes in consciousness such as feeling confused, delirious or fainting (loss of consciousness) or seizures after taking Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

    What are the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

    Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution can cause serious side effects, including:

    • See " What is the most important information I should know about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?" Changes in certain blood tests. Your healthcare provider may do blood tests after you takeSodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including: o vomiting o nausea o bloating o dizziness o stomach area (abdomen) cramping o headache o urinate less than usual o trouble drinking clear liquid o trouble swallowing o seizures o heart problems o worsening gout • Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or rectal bleeding.

    The most common side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in adults include:

    o overall discomfort o stomach bloating o stomach pain o nausea o vomiting

    The most common side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in children 12 to 16 years of age include: o nausea o stomach pain o stomach bloating o vomiting

    These are not all the possible side effects of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

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

    How should I store Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

    • Store Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution at room temperature, between 68°F to 77°F (20°C to 25°C).

    Keep Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and all medicines out of the reach of children.

    General information about the safe and effective use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution for a condition for which it was not prescribed. Do not give Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution to other people, even if they are going to have the same procedure you are. It may harm them. You can ask your pharmacist or healthcare provider for information about Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution that is written for healthcare professionals.

    What are the ingredients in Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution?

    Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is supplied in two dosage strengths. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution comes in a carton containing two 6-ounce bottles, along with a 16-ounce polypropylene mixing container. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Pediatric Oral Solution comes in a carton containing two bottles containing 4.5 ounces of oral solution, along with a 12-ounce polypropylene mixing container.

    Each bottle contains: Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate. Inactive ingredients: citric acid, USP, flavoring ingredients, malic acid, FCC, sodium benzoate, NF, sucralose, purified water, USP.

    Distributed by Affordable Pharmacuticals, LLC Braintree, MA 02185, USA For more information go to www.affordablepharma.com or call 1-800-514-5617.

    Clinical Studies

    14 CLINICAL STUDIES Adults The colon cleansing efficacy of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was evaluated in a randomized, single-blind, active-controlled, multicenter study in adult patients scheduled to have a colonoscopy. There were 363 adult patients included in the efficacy analysis. Patients ranged in age from 20 to 84 years (mean age 55 years) and 54% were female. Race distribution was 86% Caucasian, 9% African-American, and 5% other. Patients were randomized to one of the following two colon preparation regimens: Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or a marketed polyethylene glycol (PEG) plus electrolytes bowel preparation. In the Study Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was administered as a split-dose (two-day) regimen. The PEG bowel prep was also given as a split-dose preparation according to its labeled instructions. Patients receiving Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution were limited to a light breakfast followed by clear liquids on the day prior to the day of colonoscopy; patients receiving the PEG bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids. The primary efficacy endpoint was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received, as shown in Table 3. In the study, no clinically or statistically significant differences were seen between the group treated with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and the group treated with the PEG bowel prep. Table 3: Proportion of Adult Patients with Successful Colon Cleansing Response Rates 1 Responders were patients whose colon preparations were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist. 2 Does not equal difference in tabled responder rates due to rounding effects. Treatment Group Regimen N Responders 1 % (95% C. I.) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution–PEG Difference (95% CI) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (with light breakfast) Split-Dose 180 97% (94%, 99%) 2% 2 (-2%, 5%) PEG bowel prep (with normal breakfast & light lunch) Split-Dose 183 96% (92%, 98%) Pediatric Patients 12 Years to 16 Years of Age Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was evaluated for colon cleansing in a randomized, single-blind, multicenter, doseranging, active-controlled study in 89 pediatric patients 12 years to 16 years of age. The majority of patients were female (57%), white (78%), and of non-Hispanic or non-Latino ethnicity (91%). The mean age was 14 years. The median body weight was 60 kg (range 32 to 155 kg). Patients were randomized to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses), Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) or oral PEG solution. Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses); therefore, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.4 )] . Patients in the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) group took the preparation in a “split-dose” regimen, where the first dose was taken the evening before colonoscopy, with the second dose taken the morning of the exam. Patients in the control group took the preparation according to its approved labeling on the evening before colonoscopy. Patients in the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) were allowed to have a light breakfast on the day before colonoscopy, followed by clear liquids until the colonoscopy is completed the following day. Patients in the control group subjects were permitted only clear liquids on the day prior to colonoscopy until completion of the colonoscopy the following day. The primary efficacy endpoint was the proportion of patients with successful colon cleansing as assessed by the colonoscopists, who were not informed about the type of preparation received. The percentage of responders and the associated 95% confidence intervals for the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) and Oral PEG solution are shown in Table 4. Efficacy was similar between patients who weighed 65 kg or more (n=12) and those patients who weighed less than 65 kg (n=15) in the Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) arm. Table 4: Proportion of Pediatric Patients 12 Years to 16 Years of Age with Successful Colon Cleansing Response Rates 1 Responders were patients whose colon preparations were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist. 2 Does not equal difference in tabled responder rates due to rounding effects. Treatment Group Regimen N Responders 1 % (95% C. I.) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution–PEG Difference (95% CI) Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 4.5 ounces per dose (with light breakfast) Split-Dose 26 85% (71%, 99%) 25% 2 (3%, 47%) Oral PEG Solution (with clear liquids only) Evening Dosing 32 59% (42%, 76%)

    Clinical Studies Table

    Table 3: Proportion of Adult Patients with Successful Colon Cleansing Response Rates

    1 Responders were patients whose colon preparations were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist.

    2 Does not equal difference in tabled responder rates due to rounding effects.

    Treatment GroupRegimenNResponders1 % (95% C. I.)Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution–PEG Difference (95% CI)
    Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (with light breakfast)Split-Dose18097% (94%, 99%)

    2%2

    (-2%, 5%)

    PEG bowel prep (with normal breakfast & light lunch) Split-Dose18396% (92%, 98%)

    Geriatric Use

    8.5 Geriatric Use Of the 375 patients who received Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was given as a one-day preparation (not a recommended regimen). 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 )] .

    Pediatric Use

    8.4 Pediatric Use The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in this age group is supported by evidence from an adequate and well-controlled trial of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14 )] . In the pediatric trial, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses). Therefore, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.3 )] . The safety profile of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in pediatric patients less than 12 years of age have not been established.

    Pregnancy

    8.1 Pregnancy Risk Summary There are no available data on Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. 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.

    Use In Specific Populations

    8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data on Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproductive studies have not been conducted with Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution. 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. 8.2 Lactation Risk Summary There are no data available data on the presence of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in human or animal milk, the effects 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and any potential adverse effects on the breastfed child from Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) have been established for cleansing of the colon as a preparation for colonoscopy in pediatric patients 12 years of age and older. Use of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in this age group is supported by evidence from an adequate and well-controlled trial of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in adults and a single, dose-ranging, controlled trial in 89 pediatric patients 12 years to 16 years of age [see Clinical Studies ( 14 )] . In the pediatric trial, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) did not demonstrate additional treatment benefit and more patients reported gastrointestinal adverse reactions compared to Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses). Therefore, Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 6-ounce doses) is not recommended for pediatric patients 12 years of age and older [see Dosage and Administration ( 2.3 )] . The safety profile of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (two 4.5-ounce doses) in this pediatric population was similar to that seen in adults [see Adverse Reactions ( 6.1 )] . The safety and effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in pediatric patients less than 12 years of age have not been established. 8.5 Geriatric Use Of the 375 patients who received Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, administered as the recommended split-dose (2-day) regimen, were observed between geriatric patients and younger patients. Geriatric patients reported more vomiting when Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution was given as a one-day preparation (not a recommended regimen). 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 )] . 8.6 Renal Impairment Use Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution 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 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4 )] .

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) (NDC 10572-012-01) contains: Two bottles (NDC 10572-011-01) each containing 6-ounces of an oral solution of 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 16-ounce fill line. Each Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for pediatric patients 12 years of age and older) (NDC 10572-112-01) contains: Two bottles (NDC 10572-111-01) each containing 4.5-ounces of an oral solution of 13.13 grams sodium sulfate, 2.35 grams potassium sulfate, and 1.2 grams magnesium sulfate as a clear to slightly hazy liquid. When diluted as directed, the solution is clear and colorless. One (1) mixing container with a 12-ounce fill line. Store at 20° to 25°C (68° to 77°F). Excursions permitted between 15° to 30°C (59° to 86°F). See USP controlled room temperature.

    Storage And Handling

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

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