SODIUM POLYSTYRENE SULFONATE powder, for suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

SUNRISE PHARMACEUTICAL, INC.

INN (mednarodno ime):

SODIUM POLYSTYRENE SULFONATE

Sestava:

SODIUM CATION 4.1 meq in 1 g

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 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 pract

Povzetek izdelek:

Sodium polystyrene sulfonate for suspension is available as a golden brown, finely ground powder in jars of 1 pound (454 g), NDC 11534-166-44, in bottles of 15 g, NDC 11534-166-16 and 10 in 1 carton pack of 15 g per bottle, NDC 11534-166-15 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SODIUM POLYSTYRENE SULFONATE- SODIUM POLYSTYRENE SULFONATE POWDER,
FOR SUSPENSION
SUNRISE PHARMACEUTICAL, INC.
----------
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 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 golden
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 REACTIO