SODIUM POLYSTYRENE SULFONATE powder, for suspension

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Epic Pharma, LLC

INN (Internationale Bezeichnung):

SODIUM POLYSTYRENE SULFONATE

Zusammensetzung:

SODIUM POLYSTYRENE SULFONATE 4.1 meq in 1 g

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for the treatment of hyperkalemia. Limitation of Use: Sodium Polystyrene Sulfonate Powder, for Suspension should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)] . Sodium Polystyrene Sulfonate Powder, for Suspension is contraindicated in patients with the following conditions: Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk. Risk Summary Sodium Polystyrene Sulfonate Powder, for Suspension is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant. Studies of safety and efficacy have not been conducted in pediatric patients. In pediatric patients, as in adults, Sodium Polystyrene Sulfonate Powder, for Suspension is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin. In neonates, Sodium Polystyrene Sulfonate Powder, for Suspension should not be given by the oral route. In both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. Premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with Sodium Polystyrene Sulfonate Powder, for Suspension use [see Warnings and Precautions (5.4)] .

Produktbesonderheiten:

Sodium Polystyrene Sulfonate Powder, for Suspension is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g). NDC 42806-013-96, and in bottles of 15 g, NDC 42806-013-94. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER,
FOR SUSPENSION
EPIC PHARMA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM POLYSTYRENE
SULFONATE POWDER, FOR SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION
FOR SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION.
SODIUM POLYSTYRENE SULFONATE POWDER, FOR SUSPENSION, FOR ORAL OR
RECTAL USE
INITIAL U.S. APPROVAL: 1958
INDICATIONS AND USAGE
Sodium Polystyrene Sulfonate Powder, for Suspension is indicated for
the treatment of hyperkalemia (1).
Limitation of Use:
Sodium Polystyrene Sulfonate Powder, for Suspension should not be used
as an emergency treatment for
life-threatening hyperkalemia because of its delayed onset of action
(1).
DOSAGE AND ADMINISTRATION
Oral: The average total daily adult dose of Sodium Polystyrene
Sulfonate Powder, for Suspension is 15 g to
60 g, administered as a 15-g dose (four level teaspoons), one to four
times daily (2.1).
Rectal: The average adult dose is 30 g to 50 g every six hours (2.1).
DOSAGE FORMS AND STRENGTHS
Sodium Polystyrene Sulfonate Powder, for Suspension is available as a
cream to light brown, finely ground
powder (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
Adverse reactions reported include: anorexia, constipation, diarrhea,
fecal impaction, gastrointestinal
concretions (bezoars), ischemic colitis, nausea, vomiting (6).
To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC
1-888-374-2791 or FDA at 1-800-
FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2023
Hypersensitivity to polystyrene sulfonate resins (4)
Obstructive bowel disease (4)
Neonates with reduced gut motility (4)
Intestinal Necrosis: cases of intestinal necrosis and other serious
gastrointestinal events have been
reported (5.1).
Electrolyte Disturbances: Severe hypokalemia can occur. (5.2).
Fluid overload in patient sen