Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
calcium polystyrene sulfonate, Quantity: 999.3 mg/g
Sanofi-Aventis Australia Pty Ltd
Powder
Excipient Ingredients: vanillin; saccharin
Oral, Rectal
300 g
Medicine Registered
(S4) Prescription Only Medicine
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.
Visual Identification: Buff coloured very fine powder; Container Type: Jar/Can; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-10
CALCIUM RESONIUM ® C A L C I U M R E S O N I U M ® 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 Read the complete document
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 Read the complete document