SODIUM POLYSTYRENE SULFONATE powder, for suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

ATLANTIC BIOLOGICALS CORP.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Sodium polystyrene sulfonate 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 ).

ملخص المنتج:

Sodium polystyrene sulfonate is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g), NDC 51293-831-97 Store at 25° C (77º F); excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature] DISTRIBUTED BY: ATLANTIC BIOLOGICALS CORP. 20101 N.E 16TH PLACE  MIAMI, FL 33179

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER,
FOR SUSPENSION
ATLANTIC BIOLOGICALS CORP.
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SODIUM POLYSTYRENE SULFONATE POWDER FOR SUSPENSION
CATION - EXCHANGE RESIN
RX ONLY
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 is indicated for the treatment of
hyperkalemia.
CONTRAINDICATIONS
Sodium polystyrene sulfonate 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 use. The majority