Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
POWDER, FOR SUSPENSION
**PROPER USE OF THIS MEDICATION** **USUAL DOSE:** JAMP Sodium Polystyrene Sulfonate can be given by mouth or in the rectum. The amount of JAMP Sodium Polystyrene Sulfonate you need to take will depend upon the amount of potassium in your blood. Once the mixture has been prepared, it should be used straight away. If it needs to be stored, it should be stored for no longer than 24 hours. Do not heat JAMP Sodium Polystyrene Sulfonate. Your doctor will decide exactly how much JAMP Sodium Polystyrene Sulfonate you need to take. The usual doses are: **ORAL DOSING** When taken by mouth, JAMP Sodium Polystyrene Sulfonate should be taken at least 3 hours before or 3 hours after other oral medications. For patients with gastroparesis (a condition preventing your stomach from emptying properly), a 6-hour separation should be considered. Consult your health care provider for recommendations (see “WARNINGS AND PRECAUTIONS” and DRUG INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). JAMP Sodium Polystyrene Sulfonate powder is usually given by mouth mixed in a small amount of water. It can also be mixed with sweetened liquid. Do NOT mix JAMP Sodium Polystyrene Sulfonate with orange juice or fruit juice which contains potassium. JAMP Sodium Polystyrene Sulfonate is a powder. Be careful not to inhale it accidentally. Breathing in the powder may cause coughing and shortness of breath. Your doctor will regularly check the potassium, calcium and magnesium levels in your blood. The doctor may change the dose or stop the JAMP Sodium Polystyrene Sulfonate depending on what the results of these blood tests are. **Adults, including the elderly:** 15 g one to four times daily as indicated above. **Children:** You should follow the dosing recommended by your doctor. For children, JAMP Sodium Polystyrene Sulfonate is preferably given with water (NOT a fruit juice because of the high potassium content) or a little jam or honey. **Newborn babies (neonates)** **JAMP Sodium Polystyrene Sulfonate should not be given by mouth.** **RECTAL DOSING** The enema is usually given by a doctor or nurse. **Adults:** The enema should be prepared by the pharmacist or the nurse. 30 to 45g should be administered once or twice daily at interval of six hours. The enema should be retained in the rectum for as long as possible. Afterwards, the colon needs to be washed out to remove JAMP Sodium Polystyrene Sulfonate. **Children and infants:** The enema should be prepared by the pharmacist or the nurse. The enema should be retained in the rectum for as long as possible. Afterwards, the colon needs to be washed out to remove JAMP Sodium Polystyrene Sulfonate. **OVERDOSE:** Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, and eventually frank paralysis. Apnea may be a serious consequence of the progression. Electrocardiographic changes may be consistent with hypokalemia; cardiac arrhythmia may occur. Hypocalcemic tetany may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium). The resin should be removed from the alimentary tract by appropriate use of laxatives or enemas. **MISSED DOSE:** Do not take a double dose to make up for the dose you have missed. If it is almost time for the dose, skip the dose you missed and take the next dose when you are meant to.
ORAL, RECTAL
Medical Information
**INDICATION** JAMP Sodium Polystyrene Sulfonate is indicated for the treatment of hyperkalemia.
**CONTRAINDICATIONS** JAMP Sodium Polystyrene Sulfonate should not be administered to patients with the following conditions: - serum potassium <5 mmol / L - history of hypersensitivity to polystyrene sulfonate resins - obstructive bowel disease JAMP Sodium Polystyrene Sulfonate should not be administered _**orally**_ to neonates or in neonates with reduced gut motility (postoperatively or drug induced).
V03AE01
polystyrene sulfonate
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
Sava Healthcare Ltd
Active Ingredients
Documents
Patient Information Leaflets
JAMP Sodium Polystyrene Sulfonate Powder PIL.pdf
Approved: June 14, 2023