A Comprehensive Clinical Monograph on Oral Sulfate-Based Bowel Preparations: Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate

Introduction and Pharmacological Profile

Overview and Regulatory Status

The combination of sodium sulfate, potassium sulfate, and magnesium sulfate constitutes a prescription-only medication belonging to the osmotic laxative class.[1] Its primary and sole indication, as approved by the U.S. Food and Drug Administration (FDA), is the cleansing of the colon in preparation for colonoscopy.[3] This preparation is approved for use in adults and, for specific formulations, in pediatric patients aged 12 years and older.[5]

The regulatory history of this combination began with the FDA approval of the oral solution formulation, Suprep® Bowel Prep Kit, manufactured by Braintree Laboratories, Inc., on August 5, 2010.[7] This was followed by the approval of an oral tablet formulation, Sutab®, in 2020, representing a significant evolution in the drug's delivery system to improve patient tolerability.[9] Other brand names, such as Colprep®, are also available.[10] Following the expiration of market exclusivity, several manufacturers have received approval for generic versions of the oral solution, indicating a competitive post-exclusivity market landscape.[7]