Resincal

Resincal

Manufacturer:

Laboratorios Rubio

Distributor:

Macropharma Corp
Full Prescribing Info
Contents
Calcium polystyrene sulfonate.
Description
Each 15 g of powder for oral suspension contains calcium polystyrene sulfonate 14.96 g.
Action
Pharmacology: Each gram of calcium polystyrene sulfonate can theoretically exchange in vitro about 1.3-2 mmol of potassium. However, the actual amount of potassium bound in vivo will be less than this value. The resin is insoluble in water and is not absorbed from the gastrointestinal tract.
As the resin passes through the colon, it comes into contact with fluids containing increasing amounts of potassium. The result is that potassium is taken up in exchange for calcium ions and are excreted in the feces. Since the length of time the resin remains in the body is an important factor in its effectiveness, administering the resin orally is more effective than the use of enemas which should, if possible, be retained for 9 hrs. Calcium polystyrene sulfonate is not selective for potassium.
Indications/Uses
Treatment of hyperkalemia due to acute and chronic renal failure secondary to any cause.
Dosage/Direction for Use
Calcium polystyrene sulfonate may be given when serum potassium level rises above 6 mmol/L. Exchange will continue until all the resin has been voided (this may be 1 or 2 days after administration has been discontinued). For this reason, resin therapy should be stopped when the serum potassium level has fallen to 5 mmol/L to avoid hypokalemia. The following doses are suggested only as a general guide. The precise daily dose should be adjusted based on regular serum electrolyte determination.
The amount of potassium taken up by the resin will be largely determined by the length of time it is exposed to high potassium concentration in the fecal water in the colon. For this reason, a tendency towards constipation should be encouraged and purgative drugs should be avoided.
Adults: Usual Dose: 15 g (3 spoonfuls), 3 or 4 times daily given by mouth in a small volume of water (30-50 mL) or it may be made into a paste with some sweetened liquid except fruit juices that are known to contain a lot of potassium. The dosage may be adjusted according to the patient's condition and electrolyte levels.
In cases where vomiting may make oral administration difficult, or in patients who have upper gastrointestinal problems including paralytic ileus, the resin may be given rectally as a suspension of 30 g resin in 100 mL of 2% methylcellulose or 100 mL of water after warming to body temperature. Five percent (5%) glucose solution may be substituted for water or 2% methylcellulose. It is recommended that the resin should be left in the intestinal tract for 30 min to 1 hr after administration. In case the suspension leak out, the hip can be lifted up by placing a pillow underneath or ask the patient to assume a knee-chest position.
If the resin is given as a daily retention enema, the resin should be retained for at least 9 hrs since the longer the resin is retained, the greater is the amount of potassium removed.
In the initial stages, administration rectally as well as orally may help to achieve a more rapid lowering of the serum potassium level. If both routes are used initially, it is probably unnecessary to continue rectal administration once the oral resin has reached the rectum.
Children: Acute Hyperkalemia: 1 g/kg body weight daily of Resincal daily in divided doses. Maintenance Therapy: Dose may be reduced to 0.5 g/kg body weight daily in divided doses.
Resincal should be given orally, preferably with a drink or a little jam or honey. It should not be given in fruit drinks and some carbonated beverages because of their high potassium content. When the resin is refused by mouth, it may be given rectally suspended in a proportional amount of dextrose 10% in water, using a dose at least as great as that which would have been given orally. Following retention of the enema, the colon should be irrigated to ensure adequate removal of the resin.
Neonates: Only rectal administration should be considered with dose of 0.5-1 g/kg, diluted as in adults and with adequate irrigation to ensure complete recovery of the resin.
Contraindications
The resin should not be administered to patients with serum potassium <5 mmol/L; conditions associated with hypercalcemia (eg, hyperparathyroidism, multiple myeloma, sarcoidosis or metastatic carcinoma); a history of hypersensitivity to polystyrene sulfonate resins; with obstructive bowel disease.
Use in children: Oral administration of Resincal is contraindicated in neonates.
Administration of the resin in neonates with reduced gut motility (postoperatively or drug induced) is also contraindicated.
Special Precautions
Monitoring of potassium levels and other cations in the blood (sodium, calcium and magnesium) is recommended. Dosage should be adjusted if there is an electrolyte imbalance.
Use in pregnancy & lactation: Calcium polystyrene sulfonate is not absorbed from the gastrointestinal tract. No data are available about the use of polystyrene sulfonate resins in human pregnancy and lactation.
Use In Pregnancy & Lactation
Calcium polystyrene sulfonate is not absorbed from the gastrointestinal tract. No data are available about the use of polystyrene sulfonate resins in human pregnancy and lactation.
Adverse Reactions
Calcium polystyrene sulfonate may cause hypokalemia and hypercalcemia and their related clinical manifestations.
Intestinal intolerance due to the gritty consistency and bulk of the resin may be manifested by nausea, vomiting, gastric irritation, anorexia, constipation and occasionally, diarrhea. These adverse effects may be relieved by intermittent therapy and the use of mild laxatives where constipation is a factor.
Fecal impaction following rectal administration in children and gastrointestinal concretions following oral administration to neonates have been reported. Rarely, intestinal obstruction has been reported. This could possibly be a reflection of co-existing pathology or inadequate dilution of the resin.
Some cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of calcium polystyrene sulfonate have been described.
Drug Interactions
Digitalis: The toxic effects of digitalis on the heart, especially various ventricular arrhythmia and AV nodal dissociation, are likely to be exaggerated by hypokalemia, even in the phase of serum digoxin concentrations in the 'normal range'.
Cation-Donating Agents: These may reduce the effectiveness of the resin in binding potassium.
Non-Absorbable Cation-Donating Antacids and Laxatives: Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with non-absorbable cation-donating antacids and laxatives eg, magnesium and aluminum hydroxide.
Aluminum Hydroxide: Intestinal obstruction due to concretions of aluminum hydroxide has been reported when aluminum hydroxide was combined with the resins (sodium form).
Sorbitol (as an ingredient) in enemas.
Storage
Store at temperatures not exceeding 30°C. Keep in a cool and dry place.
MIMS Class
ATC Classification
V03AE01 - polystyrene sulfonate ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
Presentation/Packing
Powd for oral susp 15 g (sachet) x 26's.
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