SODIUM POLYSTYRENE SULFONATE powder

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Major Pharmaceuticals

INN (Διεθνής Όνομα):

SODIUM POLYSTYRENE SULFONATE

Σύνθεση:

SODIUM POLYSTYRENE SULFONATE 1 g in 1 g

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER
MAJOR PHARMACEUTICALS
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KIONEX
SODIUM POLYSTYRENE SULFONATE, USP
CATION-EXCHANGE RESIN
DESCRIPTION
Sodium polystyrene sulfonate is a benzene, diethenyl- polymer with
ethenylbenzene, sulfonated, sodium
salt and has the following structural formula:
CHEMICAL STRUCTURE
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 is indicated for the treatment of
hyperkalemia.
CONTRAINDICATIONS
This product 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
ALTERNATIVE THERAPY IN SEVERE HYPERKALEMIA:
Since effective lowering of serum potassium with this product may take
hours to days, treatment with
this drug alone may be insufficient to rapidly correct severe
hyperkalemia associated with states of
rapid tissue breakdown (e.g., burns a