SODIUM POLYSTYRENE SULFONATE powder, for suspension

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Alexso, Inc

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia. Limitation of Use: Sodium polystyrene sulfonate 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 is contraindicated in patients with the following conditions: - Hypersensitivity to polystyrene sulfonate resins - Obstructive bowel disease - Neonates with reduced gut motility Risk Summary Sodium polystyrene sulfonate 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 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 is expected to bind potassium at the practical exchange ratio of 1mEq

Descriptif du produit:

Sodium polystyrene sulfonate is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g), NDC 50488-5001-1. Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F) [see USP Controlled Room Temperature]

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER, FOR
SUSPENSION
ALEXSO, INC
----------
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 is a potassium binder indicated for the
treatment of hyperkalemia (1).
Limitation of Use:
Sodium polystyrene sulfonate 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 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 is available as a cream to light brown,
finely ground powder (3)
CONTRAINDICATIONS
Hype rsensitivity to polystyrene sulfonate resins (4)
Obstructive bowel disease (4)
Neonates with reduced gut motility (4)
WARNINGS AND PRECAUTIONS
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 sensitive to high sodium intake: Monitor
patients who are sensitive to sodium intake for signs
of fluid overload. (5.3).
Risk of aspiration: Acute bronchitis or bronchopneumonia caused by
inhalation of sodium polystyrene sulfonate
particles has been reported. (5.4).
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 ECI PHARMACEUTICALS