Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Polystyrene sulfonate - sodium
RESONIUM A ® _sodium polystyrene sulfonate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Resonium A. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT RESONIUM A IS USED FOR Resonium A is a type of medicine used to help remove excessive amounts of potassium from the blood. Resonium A contains sodium polystyrene sulfonate which contains sodium atoms. This sodium is swapped for potassium in the body, particularly in the large intestine. Resonium A does not enter the bloodstream from the intestine. It is passed (with the potassium ions) with the faeces. Your doctor, however, may prescribe Resonium A for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE RESONIUM A IF YOU HAVE: • a bowel obstruction • low levels of potassium (less than 5 mmol/L) DO NOT TAKE RESONIUM A IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing. DO NOT GIVE ORAL RESONIUM A TO NEWBORN BABIES. Orally administered Resonium A has caused bowel obstruction in newborns. Resonium A should only be given rectally to newborns DO NOT TAKE IT IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. DO NOT TAKE IT IF YOU ARE BREASTFEEDING OR PLANNING TO BREASTFEED. DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PAC Read the complete document
Resonium A PI #65692v3.0 Page 1 PRODUCT INFORMATION RESONIUM A NAME OF THE MEDICINE NON-PROPRIETARY NAME Sodium polystyrene sulfonate CHEMICAL STRUCTURE CAS NUMBER 28210-41-5 [9003-59-2] DESCRIPTION Resonium A contains 99.93% sodium polystyrene sulfonate as a finely ground powder. The sodium content is approximately 4.1mmol (100 mg) per gram of Resonium A. Resonium A also contains saccharin sodium and vanillin. PHARMACOLOGY CLASS Sodium polystyrene sulfonate is a cation exchange resin prepared in the sodium phase. SITE AND MODE OF ACTION It has an _in_ _vitro_ exchange capacity of approximately 3.1 mmol of potassium per gram of resin. However, _in_ _vivo_ the actual amount of potassium bound is closer to 1 mmol of potassium per gram. PHARMACOKINETICS Absorption Sodium polystyrene sulfonate is not absorbed from the gastrointestinal tract. Distribution Sodium polystyrene sulfonate removes potassium from the body by exchanging it within the gut for sodium. Excretion For the most part, this action occurs in the large intestine, which excretes potassium to a greater degree than does the small intestine. The efficiency of potassium exchange is unpredictable and variable. CH SO 3 CH 2 CH SO 3 CH 2 - - _n_ _m_ Na + Resonium A PI #65692v3.0 Page 2 INDICATIONS Treatment of hyperkalaemia. CONTRAINDICATIONS • History of hypersensitivity to polystyrene sulfonate resins. • Serum potassium levels less than 5 mmol/L • Obstructive bowel disease • Resonium A should not be administered ORALLY to neonates and is contraindicated in neonates with reduced gut motility (eg. post-operatively or drug induced) PRECAUTIONS Serious potassium deficiency can result from Resonium A therapy. It is imperative to determine serum potassium levels at least daily and more frequently when indicated, especially in patients on digoxin. Therapy should be discontinued when serum potas Read the complete document