Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z) (POLYSTYRENE SULFONIC ACID - UNII:70KO0R01RY)
Atlantic Biologicals Corps
SODIUM POLYSTYRENE SULFONATE
SODIUM POLYSTYRENE SULFONATE 1 g in 1 g
ORAL
PRESCRIPTION DRUG
Sodium Polystyrene Sulfonate, USP is indicated for the treatment of hyperkalemia. Sodium Polystyrene Sulfonate, USP is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (see ). PRECAUTIONS
NDC:17856-0036-1 in a POUCH of 15 POWDERS
Abbreviated New Drug Application
SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER ATLANTIC BIOLOGICALS CORPS ---------- SODIUM POLYSTYRENE SULFONATE, USP DESCRIPTION Sodium Polystyrene Sulfonate, USP, is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula: The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an exchange capacity of approximately 3.1 mEq ( approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema. _in vitroin vivo_ 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 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable. INDICATIONS AND USAGE Sodium Polystyrene Sulfonate, USP is indicated for the treatment of hyperkalemia. CONTRAINDICATIONS Sodium Polystyrene Sulfonate, USP is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (see ). PRECAUTIONS WARNINGS Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Sodium Polystyrene Sulfonate, USP use. The majority of these cases reported the concomitant use of sorbitol. Risk fac Les hele dokumentet