SODIUM POLYSTYRENE SULFONATE powder

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Atlantic Biologicals Corps

INN:

SODIUM POLYSTYRENE SULFONATE

composition:

SODIUM POLYSTYRENE SULFONATE 1 g in 1 g

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

NDC:17856-0036-1 in a POUCH of 15 POWDERS

authorization_status:

Abbreviated New Drug Application

SPC

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER
ATLANTIC BIOLOGICALS CORPS
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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 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