SODIUM POLYSTYRENE SULFONATE powder, for suspension

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Belcher Pharmaceuticals, LLC

INN (Tarptautinis Pavadinimas):

SODIUM POLYSTYRENE SULFONATE

Sudėtis:

SODIUM CATION 4.1 meq in 1 g

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Sodium Polystyrene Sulfonate for suspension is indicated for the treatment of hyperkalemia. 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).

Produkto santrauka:

Sodium Polystyrene Sulfonate for suspension is available as a cream to light brown, finely ground powder in bottles of 1 pound (454 g), NDC 62250-660-23. Store at 20° to 25° C (68° to 77° F) with excursions permitted between 15° to 30° C (59° – 86° F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to Belcher Pharmaceuticals, LLC at 1-727-471-0850 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Rx Only Manufactured by Belcher Pharmaceuticals, LLC Largo, FL 33777 USA Revised December 2015 L49I D-1512

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER,
FOR SUSPENSION
BELCHER PHARMACEUTICALS, LLC
----------
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION
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, USP 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 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