REXONIUM Calcium Polystyrene Sulfonate 99.8% Powder

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CALCIUM POLYSTYRENE SULFONATE

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

CALCIUM POLYSTYRENE SULFONATE

Unit dalam pakej:

100x5 gm; 10x5 gm; 100x15 gm; 10x15 gm

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REXONIUM CALCIUM POLYSTYRENE SULFONATE 99.8% POWDER
Calcium Polystyrene Sulfonate (99.8% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What REXONIUM is used for
2.
How REXONIUM works
3.
Before you use REXONIUM
4.
How to use REXONIUM
5.
While you are using REXONIUM
6.
Side effects
7.
Storage and disposal of
REXONIUM
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT REXONIUM IS USED FOR
REXONIUM
contains
Calcium
polystyrene sulfonate. It is used to treat
hyperkalemia, a condition when there is
too much potassium in your blood due to
renal failure.
HOW REXONIUM WORKS
REXONIUM works by removing extra
potassium by bring your levels back to
normal.
BEFORE YOU USE REXONIUM
_- When you must not use it _
Do not use it when you have:

allergic
to
calcium
polystyrene
sulfonate or any of its ingredients.

medical problems that result in high
level
of
calcium
such
as
thyroid
problem.

obstructive bowel disease.
_Pregnancy and lactation _
Do
not
take
REXONIUM
if
you
are
pregnant, trying to get pregnant or think
you may be pregnant.
Do
not
take
REXONIUM
if
you
are
breastfeeding.
Ask
your
doctor
or
pharmacist for advice before taking any
medicine.
_-Before you start to use it_
Check
with
your
doctor,
nurse
or
pharmacist before using REXONIUM.
REXONIUM should not be administered
orally to neonates and is contraindicated
in neonates with reduced gut movement
_ _
_-Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
REXONIUM should be used in caution
with:

Orally administered medications

Sorbitol

Cation-donating
agents
(may
reduce
the effectiveness of the resin in binding
potassium.

Medicine for indigestion (antacids)
and laxatives.

Aluminium hydroxide

Digitalis-like drugs

Lithium- for mental illness

Levothyroxin
–
for
an
underactive
thyroid.
HOW TO USE REXONIU

Ciri produk

REXONIUM CALCIUM POLYSTYRENE SULFONATE 99.8% POWDER
Name and Strength of Active Substance:
Calcium Polystyrene Sulfonate ………………………….. 99.8%
w/w
DESCRIPTION:
PRODUCT DESCRIPTION
Before reconstitution: A cream to light brown, fine powder.
After reconstitution: Yellow-brownish suspension with vanilla flavour
when reconstituted.
Each dose should be suspended in 30 - 50 mL of plain water.
For oral use only.
PHARMACODYNAMICS
Pharmacotherapeutic group: All other therapeutic products; Drugs for
treatment of hyperkalemia and hyperphosphatemia.
Ion-exchange resin
PHARMACOKINETICS
Not applicable as this product is not absorbed.
INDICATIONS
Hyperkalemia resulting from acute or chronic renal failure.
RECOMMENDED DOSE
REXOMIUM CALCIUM POLYSTYRENE SULFONATE 99.8% POWDER is for adult use
only.
Oral administration
For adults, the daily dosage is 15 - 30 g to be taken dividing into 2
- 3 times. Each dose should be suspended in 30 - 50 mL of water and
administered orally. The
dosage may be adjusted according to the patient's condition.
Administer calcium polystyrene sulfonate at least 3 hours before or 3
hours after other oral medications. Patients with gastroparesis may
require a 6-hour separation
(see section DRUG INTERACTIONS)
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
•
In patients with plasma potassium levels below 5mmol/litre.
•
Conditions associated with hypercalcaemia (e.g. hyperparathyroidism,
multiple myeloma, sarcoidosis or metastatic carcinoma).
• History of hypersensitivity to polystyrene sulfonate resins.
• Obstructive bowel disease.
•
REXONIUM should not be administered orally to neonates and is
contraindicated in neonates with reduced gut motility
(post-operatively or drug-induced).
• Hypersensitivity to the active substance or to any of the
excipients.
WARNING AND PRECAUTIONS
BINDING TO OTHER ORALLY ADMINISTERED MEDICATIONS:
REXONIUM may bind to orally administered medications, which could
decrease their gastrointestinal
absorption and efficacy. Avoid co-administration of REXONIU