SODIUM POLYSTYRENE SULFONATE suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

West-Ward Pharmaceuticals Corp.

Designación común internacional (DCI):

SODIUM POLYSTYRENE SULFONATE

Composición:

SODIUM POLYSTYRENE SULFONATE 15 g in 60 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Sodium polystyrene sulfonate 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, oral or rectal administration in neonates (see PRECAUTIONS ).

Resumen del producto:

Sodium Polystyrene Sulfonate Suspension USP 15 g per 60 mL is supplied as a (wild-cherry flavored) amber smooth suspension. NDC 0054-0379-51: Unit dose bottles filled to deliver 60 mL NDC 0054-0379-50: Unit of use enema bottles filled to contain 120 mL (for use in delivering the suspension rectally through appropriate tubing) NDC 0054-0379-55: Unit of use enema bottles filled to contain 200 mL (for use in delivering the suspension rectally through appropriate tubing) NDC 0054-0379-63: Bottles of 500 mL Dispense in a tight, child-resistant container as defined in the USP/NF. If repackaging into other containers, store in refrigerator and use within 14 days of packaging. SHAKE WELL BEFORE USING. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 10007838/03 Revised May 2016

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE SUSPENSION
WEST-WARD PHARMACEUTICALS CORP.
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SODIUM POLYSTYRENE SULFONATE SUSPENSION USP
RX ONLY
DESCRIPTION
Sodium Polystyrene Sulfonate Suspension USP can be administered orally
or in an enema. It is a cherry-
flavored suspension containing 15 grams of cation-exchange resin
(Sodium Polystyrene Sulfonate USP).
In addition sodium polystyrene sulfonate suspension contains the
following inactive ingredients: citric
acid (anhydrous), artificial flavor (wild-cherry), magnesium aluminum
silicate, methylparaben,
propylene glycol, propylparaben, purified water and sucralose.
Sodium polystyrene sulfonate is a benzene, diethenyl-, polymer with
ethenylbenzene, sulfonated, sodium
salt and has the following structural formula:
The sodium content of the suspension is 1575 mg (68.5 mEq) per 60 mL
which is equivalent to 1500 mg
on the anhydrous basis. It is an amber, smooth suspension with an
_in-vitro_ exchange capacity of
approximately 3.1 mEq (_in-vivo_ approximately 1 mEq) of potassium per
4 mL (1 gram) of suspension. 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%, 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
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,
or