SODIUM POLYSTYRENE SULFONATE powder, for 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:

CMP Pharma, Inc.

INN (International Name):

SODIUM POLYSTYRENE SULFONATE

Composition:

SODIUM POLYSTYRENE SULFONATE 1 g in 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is indicated for the treatment of hyperkalemia. Limitation of Use: SODIUM POLYSTYRENE SULFONATE 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 FOR SUSPENSION 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 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 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 SULFONA

Product summary:

SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is available as a light brown to brown, finely ground powder in jars of 1 pound (454 g), NDC 46287-012-16. Store at 20° - 25° C (68° - 77° F); excursions permitted to 15° – 30° C (59° – 86° F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER, FOR
SUSPENSION
CMP PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM POLYSTYRENE SULFONATE FOR
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR SODIUM POLYSTYRENE
SULFONATE FOR SUSPENSION
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION, FOR ORAL OR RECTAL USE
INITIAL U.S. APPROVAL: 1958
INDICATIONS AND USAGE
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION is a potassium binder
indicated for the treatment of
hyperkalemia (1).
Limitation of Use:
SODIUM POLYSTYRENE SULFONATE FOR SUSPENSION should not be used 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 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 FOR SUSPENSION is available as a light
brown to brown, finely ground powder
(3)
CONTRAINDICATIONS
Hypersensitivity 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