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:

Cardinal Health 107, LLC

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:

SPS® Suspension 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:

SPS® Suspension is a light brown, cherry-flavored suspension supplied: Overbagged with 2 x 60 mL unit dose bottles, NDC 55154-7353-2. Dispense in a tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging. SHAKE WELL BEFORE USING. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. CMP Pharma, Inc. P.O. Box 147 Farmville, North Carolina 27828 Distributed By: Cardinal Health Dublin, OH 43017 L45323470124 Revised August 2021 3081 R0821

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE
SULFONATE SUSPENSION
CARDINAL HEALTH 107, LLC
----------
SPS SUSPENSION
SODIUM POLYSTYRENE
SULFONATE SUSPENSION, USP
CMP PHARMA, INC.
CATION-EXCHANGE RESIN
RX ONLY
DESCRIPTION
Sodium Polystyrene Sulfonate Suspension USP (SPS Suspension) 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); 21.5 ML OF SORBITOL
SOLUTION
USP (EQUIVALENT TO APPROXIMATELY 20 GRAMS OF SORBITOL); 0.18 mL (0.3%)
of
Alcohol per 60 mL of suspension. Also contains Purified Water USP;
Propylene Glycol
USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP;
Methylparaben NF;
Propylparaben NF; and flavor.
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 1500 mg (65 mEq) per 60 mL. It
is a brown,
slightly viscous 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.
®
®
INDICATION AND USAGE
SPS Suspension is indicated for the treatment of hyperkalemia.
CONTRAINDICATIONS
SPS Suspension is contraindicated in the following conditions:
patients with
hypokalemia, patients with a history of hypersensitivity to
polystyrene sulfonate resins