SODIUM POLYSTYRENE SULFONATE powder, for suspension

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Marlex Pharmaceuticals Inc

INN (International Adı):

SODIUM POLYSTYRENE SULFONATE

Kompozisyon:

SODIUM CATION 4.1 meq in 1 g

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Sodium polystyrene sulfonate for suspension is indicated for the treatment of hyperkalemia. 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 )

Ürün özeti:

Sodium polystyrene sulfonate for suspension is available as a golden brown, finely ground powder in jars of 1 pound (454 g), NDC 10135-0146-17 and in bottles of 15 g, NDC 10135-0146-14. Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F) [see USP Controlled Room Temperature] Rx Only Manufactured for: Marlex Pharmaceuticals Inc. New Castle, DE 19720 Made in U.S.A Rev. 03/16SP

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER,
FOR SUSPENSION
MARLEX PHARMACEUTICALS INC
----------
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION
CATION-EXCHANGE RESIN
DESCRIPTION
Sodium polystyrene sulfonate is a benzene, diethenyl- polymer, with
ethenylbenzene,
sulfonated, sodium salt and has the following structural formula:
The drug is a golden 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 for suspension 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 of these