Sodium sulfate, potassium sulfate and magnesium sulfate

Sodium sulfate, potassium sulfate and magnesium sulfate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

Disclaimer

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Overview

Sodium sulfate, potassium sulfate and magnesium sulfate is a laxative that is FDA approved for the treatment of for cleansing of the colon as a preparation for colonoscopy in adults. Common adverse reactions include atrioventricular block, hyperbilirubinemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• SUPREP Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium sulfate, potassium sulfate and magnesium sulfate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium sulfate, potassium sulfate and magnesium sulfate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sodium sulfate, potassium sulfate and magnesium sulfate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium sulfate, potassium sulfate and magnesium sulfate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium sulfate, potassium sulfate and magnesium sulfate in pediatric patients.

Contraindications

Gastrointestinal obstruction

• Bowel perforation
• Gastric retention
• Ileus
• Toxic colitis or toxic megacolon
• Known allergies to components of the kit

Warnings

Serious Fluid and Serum Chemistry Abnormalities

• Advise all patients to hydrate adequately before, during, and after the use of SUPREP Bowel Prep Kit. If a patient develops significant vomiting or signs of dehydration after taking SUPREP Bowel Prep Kit, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.
• Patients with electrolyte abnormalities should have them corrected before treatment with SUPREP Bowel Prep Kit. In addition, use caution when prescribing SUPREP Bowel Prep Kit for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment.
• SUPREP Bowel Prep Kit can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. The potential for uric acid elevation should be considered before administering SUPREP Bowel Prep Kit to patients with gout or other disorders of uric acid metabolism.

Cardiac Arrhythmias

• There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing SUPREP Bowel Prep Kit for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

Seizures

• There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
• Use caution when prescribing SUPREP Bowel Prep Kit for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

Renal Impairment

• Use caution when prescribing SUPREP Bowel Prep Kit for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Colonic Mucosal Ulcerations and Ischemic Colitis=

• Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUPREP Bowel Prep Kit may increase these risks. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

Use in Patients with Significant Gastrointestinal Disease

• If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUPREP Bowel Prep Kit.
• Use with caution in patients with severe active ulcerative colitis.

Aspiration

• Use with caution in patients with impaired gag reflex and patients prone to regurgitation or aspiration. Such patients should be observed during administration of SUPREP Bowel Prep Kit solution.

Not for Direct Ingestion

• Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

Adverse Reactions

Clinical Trials Experience

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.
• In a multicenter, controlled clinical trial comparing SUPREP Bowel Prep Kit with a bowel prep containing polyethylene glycol and electrolytes (PEG + E) that were administered in a split-dose (2-day) regimen, the most common adverse reactions after administration of SUPREP Bowel Prep Kit were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache; see TABLE 1, below. Less common Adverse Reactions occurring were AV Block (1 case) and CK increase. In this study, patients receiving SUPREP Bowel Prep Kit were limited to a light breakfast followed by clear liquids; patients receiving the PEG + E bowel prep were allowed to have a normal breakfast and a light lunch, followed by clear liquids.

This image is provided by the National Library of Medicine.

TABLE 2 shows the percentages of patients who developed new abnormalities of important electrolytes and uric acid after completing the bowel preparation with either SUPREP Bowel Prep Kit or PEG+E administered as a split-dose (2-day) regimen.

This image is provided by the National Library of Medicine.

• Percent (n/N) of patients where N=number of patients with normal baseline who had abnormal values at the timepoint(s) of interest.

†Patients with normal bicarbonate at baseline who developed low bicarbonate (≤ 21 mEq/L) and high anion gap (≥ 13 mEq/L) on Day of Colonoscopy or Day 30.

• There were also 408 patients who participated in a study in which either SUPREP Bowel Prep Kit or PEG+E were administered in an evening-only (1-day) regimen. Higher rates of overall discomfort, abdominal distention, and nausea were observed with the evening-only (1-day) regimen compared to the split-dose (2-day) regimen for both preparations. Patients treated with SUPREP Bowel Prep Kit had increased rates of vomiting with the evening-only (1-day) regimen.
• An evening-only (1-day) dosing regimen was associated with higher rates of abnormal values for some electrolytes when compared to the split-dose (2-day) regimen for both preparations. For SUPREP Bowel Prep Kit, the evening-only (1-day) regimen was associated with higher rates of total bilirubin (high), BUN (high), creatinine (high), osmolality (high), potassium (high) and uric acid (high) than the SUPREP Bowel Prep Kit split-dose (2-day) regimen. Administration of SUPREP Bowel Prep Kit in an evening-only (1-day) dosing regimen is not recommended.

Postmarketing Experience

• Hyperbilirubenemia

Drug Interactions

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing SUPREP Bowel Prep Kit for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate in patients taking these concomitant medications.

Potential for Altered Drug Absorption

• Oral medication administered within one hour of the start of each SUPREP Bowel Prep Kit dose may be flushed from the gastrointestinal tract, and the medication may not be absorbed properly.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproduction studies have not been conducted with SUPREP Bowel Prep Kit. It is also not known whether SUPREP Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SUPREP Bowel Prep Kit should be given to a pregnant woman only if clearly needed.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium sulfate, potassium sulfate and magnesium sulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium sulfate, potassium sulfate and magnesium sulfate during labor and delivery.

Nursing Mothers

• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SUPREP Bowel Prep Kit is administered to a nursing woman.

Pediatric Use

There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate with respect to pediatric patients.

Geriatic Use

• Of the 375 patients who received SUPREP Bowel Prep Kit 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 SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients.
• Geriatric patients reported more vomiting when SUPREP Bowel Prep Kit was given as a one-day preparation.

Gender

There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sodium sulfate, potassium sulfate and magnesium sulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.

Overdosage

There is limited information regarding Sodium sulfate, potassium sulfate and magnesium sulfate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sodium sulfate, potassium sulfate and magnesium sulfate Pharmacology in the drug label.

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.

Structure

• Each SUPREP Bowel Prep Kit contains two 6 ounce bottles of solution. Each 6 ounce bottle contains: sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, magnesium sulfate 1.6 grams. Inactive ingredients include: sodium benzoate, NF, sucralose, malic acid FCC, citric acid USP, flavoring ingredients, purified water, USP. The solution is a clear to slightly hazy liquid. The solution is clear and colorless when diluted to a final volume of 16 ounces with water.

Sodium Sulfate, USP

This image is provided by the National Library of Medicine.

Pharmacodynamics

• The osmotic effect of the unabsorbed ions, when ingested with a large volume of water, produces a copious watery diarrhea.

Pharmacokinetics

• Fecal excretion was the primary route of sulfate elimination. After administration of SUPREP Bowel Prep Kit in six healthy volunteers, the time at which serum sulfate reached its highest point (Tmax) was approximately 17 hours after the first half dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours.
• The disposition of sulfate after SUPREP Bowel Prep Kit was also studied in patients (N=6) with mild-moderate hepatic impairment (Child-Pugh grades A and B) and in patients (N=6) with moderate renal impairment (creatinine clearance of 30 to 49 mL/min). The renal impairment group had the highest serum sulfate AUC and Cmax, followed by the hepatic impairment group, and then by healthy subjects. Systemic exposure of serum sulfate (AUC and Cmax) was similar between healthy subjects and hepatic impairment patients. Renal impairment resulted in 54% higher mean AUC and 44% higher mean Cmax than healthy subjects. The mean sulfate levels of all three groups returned to their respective baseline levels by Day 6 after dose initiation. Urinary excretion of sulfate over 30 hours, starting after the first half dose, was similar between hepatic patients and normal volunteers, but was approximately 16% lower in moderate renal impairment patients than in healthy volunteers.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• Long-term studies in animals have not been performed to evaluate the carcinogenic potential of SUPREP Bowel Prep Kit. Studies to evaluate the possible impairment of fertility or mutagenic potential of SUPREP Bowel Prep Kit have not been performed.

Animal Toxicology and/or Pharmacology

• The sulfate salts of sodium, potassium, and magnesium contained in SUPREP Bowel Prep Kit 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.

Clinical Studies

The colon cleansing efficacy of SUPREP Bowel Prep Kit was evaluated in a randomized, single-blind, active-controlled, multicenter study. In this study, 363 adult patients were 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: SUPREP Bowel Prep Kit or a marketed polyethylene glycol (PEG) bowel prep. In the Study SUPREP Bowel Prep Kit was administered according to a split-dose preparation regimen. The PEG bowel prep was also given as a split-dose preparation according to its labeled instructions. Patients receiving SUPREP Bowel Prep Kit 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. In the study, no clinically or statistically significant differences were seen between the group treated with SUPREP Bowel Prep Kit and the group treated with the PEG bowel prep. See TABLE 3 below.

This image is provided by the National Library of Medicine.

How Supplied

• Each SUPREP Bowel Prep Kit contains:

• Two (2) 6 ounce bottles of oral solution.
• One (1) 19 ounce mixing container with a 16 ounce fill line.

Storage

• 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.
• Keep out of reach of children.
• SUPREP Bowel Prep Kit NDC 52268-012-01

Images

Drug Images

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Patient Counseling Information

• Ask patients to let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
• Instruct patients that each bottle needs to be diluted in water before ingestion and that they need to drink additional water according to the instructions. Direct ingestion of the undiluted solution may increase the risk of nausea, vomiting, and dehydration.
• Inform patients that oral medications may not be absorbed properly if they are taken within one hour of starting each dose of SUPREP Bowel Prep Kit.
• Tell patients not to take other laxatives while they are taking SUPREP Bowel Prep Kit

Precautions with Alcohol

• Alcohol-Sodium sulfate, potassium sulfate and magnesium sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• SUPREP BOWEL PREP®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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