SODIUM POLYSTYRENE SULFONATE powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z) (POLYSTYRENE SULFONIC ACID - UNII:70KO0R01RY)

Available from:

ATLANTIC BIOLOGICALS CORP

INN (International Name):

SODIUM POLYSTYRENE SULFONATE

Composition:

SODIUM POLYSTYRENE SULFONATE 1 g in 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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).

Product summary:

Sodium Polystyrene Sulfonate, USP is available as a cream to light brown, finely ground powder in NDC 17856-1136-1    15 gram unit dose pouch Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Rx Only Distributed by: Atlantic Biologicals Miami, Fl 33179

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER
ATLANTIC BIOLOGICALS CORP
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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 _in vitro_
exchange capacity of approximately
3.1 mEq (_in vivo_ 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.
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
INTESTINAL NECROSIS: 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