RESONIUM A sodium polystyrene sulfonate powder bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium polystyrene sulfonate, Quantity: 999.3 mg/g

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

sodium polystyrene sulfonate

Pharmaceutical form:

Powder

Composition:

Excipient Ingredients: saccharin; vanillin

Administration route:

Oral, Rectal

Units in package:

454g

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hyperkalaemia.

Product summary:

Visual Identification: Buff coloured powder; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-10

Patient Information leaflet

RESONIUM A
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING RESONIUM A?
Resonium A contains the active ingredient sodium polystyrene
sulfonate. Resonium A is used to help remove excessive amounts of
potassium from the blood. For more information, see Section 1. Why am
I using Resonium A? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RESONIUM A?
Do not use if you have ever had an allergic reaction to Resonium A or
any of the ingredients listed at the end of the CMI, have a
bowel obstruction, or have low levels of potassium. TALK TO YOUR
DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING. For more information, see Section 2. What
should I know before I use Resonium A? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Resonium A and affect how it works.
A list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE RESONIUM A?
•
Resonium A can be given by mouth or rectally (via the back passage).
•
The usual oral doses are 15 g three to four times daily for adults,
and 1 g/kg of body weight in divided doses for children. Take
Resonium A at least 3 hours before or 3 hours after other oral
medications.
•
The usual rectal (back passage) doses are 30 - 50 g in 150 mL of water
or 10% dextrose in water, as a retention enema for
adults, with lower dosages usually used for infants and children. Your
pharmacist will make this up. For infants and children, this
enema will usually be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use Resonium A?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RESONIUM A?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Resonium A.
•
Be sure to keep all of yo

Summary of Product characteristics

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Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION – RESONIUM A
(SODIUM POLYSTYRENE SULFONATE) POWDER
1
NAME OF THE MEDICINE
Sodium polystyrene sulfonate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Resonium A contains 99.93% sodium polystyrene sulfonate, saccharin
sodium and vanillin.
The sodium content is approximately 4.1mmol (100 mg) per gram of
Resonium A.
Excipients with known effect: saccharin.
3
PHARMACEUTICAL FORM
Buff coloured powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hyperkalaemia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Resonium A is for oral or rectal administration only. The dosage
recommendations detailed
below are a guide only; the precise requirements should be determined
on the basis of regular
clinical and serum electrolyte monitoring.
_ADULTS _
Oral
15 g three to four times daily. Each dose should be given as a
suspension in a small amount
of water or, for greater palatability, in syrup (but not fruit juices,
which contain potassium), in
the ratio of 3-4 mL per gram of resin.
Administer at least 3 hours before or 3 hours after other oral
medications. For patients with
gastroparesis, a 6-hour separation should be considered (see Section
4.4 - Special Warnings
and Precautions for Use and Section 4.5 - Interactions with Other
Medicines and Other Forms
of Interactions).
resonium-a-ccdsv7-piv6-30jun22
Page 2 of 9
Rectal
In cases where vomiting or upper gastrointestinal problems, including
paralytic ileus, may
make oral administration difficult, Resonium A may be given rectally
in a suspension of 30 g
to 50 g resin in 150 mL water or 10% dextrose in water, given as a
daily retention enema. In
the initial stages, administration by this route as well as orally may
help to achieve a more
rapid lowering of the serum potassium level.
The enema should if possible be retained for at least nine hours,
following which the colon
should be irrigated to remove the resin. If both routes are used at
first, it is probably
unnecessary to continue rectal administra