SODIUM POLYSTYRENE SULFONATE suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Trigen Laboratories, LLC

INN (International Name):

SODIUM POLYSTYRENE SULFONATE

Sammensætning:

SODIUM CATION 4.1 meq in 1 g

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE SUSPENSION
TRIGEN LABORATORIES, LLC
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SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION
DESCRIPTION
Sodium polystyrene sulfonate 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.
INDICATION AND USAGE
Sodium polystyrene sulfonate for suspension is indicated for the
treatment of hyperkalemia
CONTRAINDICATIONS
Sodium polystyrene sulfonate for suspension 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 for suspension use. The majority of these cases