KAYEXALATE POWDER FOR SUSPENSION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SODIUM POLYSTYRENE SULFONATE

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

V03AE01

INN (Nama Internasional):

POLYSTYRENE SULPHONATE

Dosis:

1G

Bentuk farmasi:

POWDER FOR SUSPENSION

Komposisi:

SODIUM POLYSTYRENE SULFONATE 1G

Rute administrasi :

ORAL

Unit dalam paket:

454 GM

Jenis Resep:

Prescription

Area terapi:

POTASSIUM-REMOVING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108701006; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-05-08

Karakteristik produk

_KAYEXALATE Prescribing Information _
_Page 1 of 13 _
PRESCRIBING INFORMATION
Pr
KAYEXALATE
®
(Sodium Polystyrene Sulfonate)
Cation - Exchange Resin
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
June 24, 2022
Submission
Control No.: 263510
_KAYEXALATE Prescribing Information _
_Page 2 of 13_
DESCRIPTION
KAYEXALATE (sodium polystyrene sulfonate) is a cream or light brown
fine powder of
sodium polystyrene sulfonate. KAYEXALATE is a cation-exchange resin
prepared in the
sodium phase, with an _in vivo_ exchange capacity of approximately
1 mmol (_in vitro_
approximately 3.1 mmol) of potassium per gram. The sodium content is
approximately
4.1 mmol
(100 mg) per gram of the drug. KAYEXALATE can be administered either
orally or as an
enema.
ACTION
Sodium polystyrene sulfonate is not absorbed from the gastrointestinal
tract. As the resin passes
through the gastrointestinal
tract, the resin removes the potassium ions by exchanging it for
sodium ions. Most of this action occurs in the large intestine, which
excretes potassium ions to a
greater degree than does the small intestine. Potassium exchange also
occurs in the colon
following
retention of the resin, when administered as an enema. The efficiency
of this process is
limited and unpredictable. It commonly approximates the order of 33
per cent but the range is so
large that definite indices of electrolyte balance must be clearly
monitored. Metabolic data are
unavailable.
INDICATION
KAYEXALATE is indicated for the treatment of hyperkalemia.
CONTRAINDICATIONS
KAYEXALATE should not be administered to patients with the following
conditions:

serum potassium <5 mmol/L

history of hypersensitivity
to polystyrene sulfonate resins

obstructive bowel disease
KAYEXALATE should not be administered _ ORALLY_ to neonates or in
neonates with reduced gut
motility (postoperatively or drug induced).
WARNINGS AND PRECAUTIONS_ _
ALTERNATIVE THERAPY IN SEVERE HYPERKALEMIA: Since effective lowering
of serum potassium
with KAYEXALATE ma