Sodium Polystyrene Sulfonate
SPS SUSPENSION Sodium Polystyrene Sulfonate Suspension, USP
12d48dcf-07bd-4b06-bd6c-7543f1be8357
HUMAN PRESCRIPTION DRUG LABEL
Aug 15, 2021
CMP Pharma, Inc.
DUNS: 005224175
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sodium polystyrene sulfonate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
INDICATIONS & USAGE SECTION
INDICATION AND USAGE
SPS® Suspension is indicated for the treatment of hyperkalemia.
SPL UNCLASSIFIED SECTION
CMP Pharma, Inc.
Cation-Exchange Resin
Rx Only
DESCRIPTION SECTION
DESCRIPTION
Sodium Polystyrene Sulfonate Suspension USP (SPS® Suspension) can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate USP);21.5 mL of Sorbitol Solution USP (equivalent to approximately 20 grams of Sorbitol); 0.18 mL (0.3%) of Alcohol per 60 mL of suspension. Also contains Purified Water USP; Propylene Glycol USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP; Methylparaben NF; Propylparaben NF; and flavor.
Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:
The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.
CLINICAL PHARMACOLOGY SECTION
CLINICAL PHARMACOLOGY
As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.
Metabolic data are unavailable.