SODIUM POLYSTYRENE SULFONATE- sodium polystyrene sulfonate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sodium Polystyrene Sulfonate (UNII: 1699G8679Z) (POLYSTYRENE SULFONIC ACID - UNII:70KO0R01RY)

Available from:

Paddock Laboratories, LLC

INN (International Name):

Sodium Polystyrene Sulfonate

Composition:

Sodium Polystyrene Sulfonate 15 g in 60 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Polystyrene Sulfonate Suspension, USP 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 (particularly in premature infants), and in any post-operative patient until normal bowel function resumes (see PRECAUTIONS ).

Product summary:

Sodium Polystyrene Sulfonate Suspension, USP is a light brown, raspberry-flavored suspension supplied as follows: 473 mL (16 Fluid Ounce) NDC 0574-2003 -16 Unit-Dose 60 mL (2 Fluid Ounce) NDC 0574-2003 -02 Dispense in 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° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE SUSPENSION
PADDOCK LABORATORIES, LLC
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SODIUM POLYSTYRENE SULFONATE SUSPENSION, USP
SORBITOL FREE
RX ONLY
DESCRIPTION
Sodium Polystyrene Sulfonate Suspension, USP can be administered
orally or in an enema. It is a
raspberry-flavored suspension containing 15 grams of cation-exchange
resin (sodium polystyrene
sulfonate, USP); 0.12 mL (0.2%) of alcohol per 60 mL of suspension.
Also contains purified water,
propylene glycol, magnesium aluminum silicate, xanthan gum, sodium
saccharin, citric acid,
methylparaben, propylparaben, 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
Sodium Polystyrene Sulfonate Suspension, USP is indicated for the
treatment of hyperkalemia.
CONTRAINDICATIONS
Sodium Polystyrene Sulfonate Suspension, USP 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 (particular