CALCIUM RESONIUM calcium polystyrene sulfonate powder can

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium polystyrene sulfonate, Quantity: 999.3 mg/g

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Powder

Composition:

Excipient Ingredients: vanillin; saccharin

Administration route:

Oral, Rectal

Units in package:

300 g

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Calcium Resonium is an ion-exchange resin. It is recommended for the treatment of hyperkalaemia associated with anuria and severe oliguria.,It is also used to treat hyperkalaemia in patients requiring dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis.

Product summary:

Visual Identification: Buff coloured very fine powder; Container Type: Jar/Can; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-10

Patient Information leaflet

CALCIUM RESONIUM
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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 CALCIUM RESONIUM?
Calcium Resonium contains the active ingredient calcium polystyrene
sulfonate. Calcium Resonium is used to help remove
excessive amounts of potassium from the blood. For more information,
see Section 1. Why am I using Calcium Resonium? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CALCIUM RESONIUM?
Do not use if you have ever had an allergic reaction to Calcium
Resonium or any of the ingredients listed at the end of the
CMI, have a bowel obstruction, have high calcium levels in the blood,
have high levels of parathyroid hormone, have multiple
myeloma (a cancer of the blood) or sarcoidosis, 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 Calcium
Resonium? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Calcium Resonium 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 CALCIUM RESONIUM?
•
Calcium Resonium 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. Do not
take Calcium Resonium with fruit juices or sorbitol. Take Calcium
Resonium at least 3 hours before or 3 hours after other oral
medications.
•
The usual rectal doses are 30 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. For newborn babies, the
minimum effective dose range 0.5 g/kg to 1 g/kg should
be used.
More instructions can be found

Summary of Product characteristics

calcium-resonium-ccdsv7-piv8-23mar22
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION -
CALCIUM RESONIUM (CALCIUM POLYSTYRENE SULFONATE) POWDER
1
NAME OF THE MEDICINE
Calcium polystyrene sulfonate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Calcium Resonium contains 99.93% calcium polystyrene sulfonate ground
and flavoured to a
vanilla odour and sweet taste. The sodium content of Calcium Resonium
is less than 1 mg/g.
Calcium content is about 8% w/w (1.6-2.4 mmol/g).
EXCIPIENTS WITH KNOWN EFFECT:
Saccharin sodium.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Buff coloured very fine powder.
Once reconstituted, Calcium Resonium is a cream to light brown
coloured suspension in
which small white particulates may remain visible.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Calcium Resonium is an ion-exchange resin. It is recommended for the
treatment of
hyperkalaemia associated with anuria and severe oliguria.
It is also used to treat hyperkalaemia in patients requiring dialysis
and in patients on regular
haemodialysis or on prolonged peritoneal dialysis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Calcium Resonium 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.
calcium-resonium-ccdsv7-piv8-23mar22
Page 2 of 9
ADULTS, INCLUDING THE ELDERLY
_ORAL _
Usual dose 15 g three or four times a day. The resin is given by mouth
as a suspension in a
small amount of water (3-4 mL per gram of resin), or it may be mixed
with some sweetened
vehicle (but not fruit juices, which contain potassium).
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).
_RECTAL _
In cases where vomiting or upper g