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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 electrolyteabnormalities (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
There is limited information regarding Clinical Trial Experience of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
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
There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate with respect to nursing mothers.
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
There is no FDA guidance on the use of Sodium sulfate, potassium sulfate and magnesium sulfate with respect to geriatric patients.
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
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.
Pharmacology
There is limited information regarding Sodium sulfate, potassium sulfate and magnesium sulfate Pharmacology in the drug label.
There is limited information regarding Patient Counseling Information of Sodium sulfate, potassium sulfate and magnesium sulfate in the drug label.
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.
