FDA

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Approved 18 Oct 2024OralSolution

The FDA lists this product in 7 strengths and forms.

Indications

Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult patients. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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 patients. ( 1 )

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 )

Warnings and precautions

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 )

Indications

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 patients. ( 1 )

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 )

Warnings and precautions

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 )

Adverse reactions

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) ] Most common adverse reactions are:
Adults (>2%): overall discomfort, abdominal distention, abdominal pain, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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 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 * reported in at least 2% of patients 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 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) 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.

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. Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Serious Fluid and Serum Chemistry Abnormalities

5.2Cardiac Arrhythmias

5.3Seizures

5.4Use in Patients with Risk of Renal Injury

5.5Colonic Mucosal Ulcerations and Ischemic Colitis

5.6Use in Patients with Significant Gastrointestinal Disease

5.7Aspiration Patients

Interactions

7.1Drugs That May Increase Risk of Fluid and Electrolyte Abnormalities

7.2Potential for Reduced Drug Absorption

7.3Stimulant Laxatives

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

Composition

Strengths and forms

Official product information

At a glance