Kalimeit (Powder) Instructions for Use

Marketing Authorization Holder

R-Pharm JSC (Russia)

Manufactured By

Ortat, JSC (Russia)

ATC Code

V03AE01 (Polystyrene sulfonate)

Active Substance

Calcium polystyrene sulphonate (BP British Pharmacopoeia)

Dosage Form

Kalimeit

Powder for oral suspension 1 g: sachet 5 g 21 pcs

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral suspension crystalline, from white with a yellowish tint to light yellow in color, odorless; after mixing with water, a homogeneous suspension of a yellowish-white or light yellow color is formed, and sedimentation may be observed; upon manual shaking, the particles easily go into suspension.

5 g – sachets made of combined material (21) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of hyperkalemia

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

Calcium-containing cation exchange resin. After oral administration into the gastrointestinal tract, the calcium cation of the resin is released into the blood, being replaced by the potassium cation from the patient’s blood (mainly in the large intestine), which explains the therapeutic effect of the drug in hyperkalemia.

Unlike sodium-containing cation exchange resins, it does not lead to an increase in serum sodium and phosphate levels and a decrease in serum calcium levels in patients with renal failure. It can be used even in patients with restricted sodium intake. Furthermore, this agent can be used without the risk of the onset and increased severity of arterial hypertension, heart failure, and edema caused by sodium administration.

Pharmacokinetics

It is not absorbed and is excreted in the feces as an unchanged polystyrene sulfonate resin.

However, there are data that particles smaller than 5 µm were absorbed through the mucous membrane and deposited in the tissues of the reticuloendothelial system.

Indications

Hyperkalemia caused by acute or chronic renal failure.

ICD codes

Dosage Regimen

Administer orally as a suspension. The dosage regimen is individual and must be determined by a physician based on the severity of hyperkalemia and the patient’s clinical condition.

For adults, the typical initial dose is 15 g administered one to four times daily. Prepare the suspension by mixing the entire contents of one 5 g sachet with 30-60 mL of water or syrup. Stir to form a uniform suspension and administer immediately.

Adjust the maintenance dose based on serial serum potassium measurements. The goal is to maintain serum potassium within the target range while avoiding hypokalemia. Monitor serum potassium levels daily during the initial phase of therapy and periodically thereafter.

Closely monitor for signs of hypercalcemia, especially in patients with renal impairment. Assess serum calcium levels weekly during treatment. Discontinue treatment if hypercalcemia develops.

In elderly patients or those prone to constipation, use a lower initial dose and increase cautiously. Do not administer concurrently with sorbitol due to the risk of intestinal necrosis.

The duration of treatment depends on the normalization of serum potassium. Do not use if plasma potassium concentration is below 5 mmol/L. Discontinue use if severe constipation, abdominal pain, or distension occurs.

Adverse Reactions

Metabolism and nutrition disorders common – hypokalemia, anorexia; uncommon – hypercalcemia; rare – hypomagnesemia.

Gastrointestinal system disorders common – constipation, nausea, stomach discomfort, anorexia; uncommon – vomiting, diarrhea; rare – intestinal perforation, ischemic colitis or intestinal necrosis, intestinal obstruction.

Respiratory system disorders: rare – cases of acute bronchitis and/or bronchopneumonia associated with the inhalation of calcium polystyrene sulfonate particles have been reported.

Skin and subcutaneous tissue disorders rash.

Contraindications

Hypersensitivity to polystyrene sulfonate in history; intestinal obstruction; conditions accompanied by hypercalcemia (e.g., hyperparathyroidism, multiple myeloma, sarcoidosis, metastatic carcinoma); plasma potassium concentration below 5 mmol/l; age under 18 years (due to insufficient data on efficacy and safety); concomitant use with sorbitol.

Use in Pregnancy and Lactation

Not used in newborns, therefore, administration to patients with hyperkalemia during lactation is not recommended.

Pediatric Use

Contraindicated for use under the age of 18 years (due to insufficient data on efficacy and safety).

Geriatric Use

Closer medical supervision and the use of lower doses of the drug are recommended.

Special Precautions

Use with caution in patients prone to constipation (risk of intestinal obstruction or perforation); in patients with intestinal stenosis (intestinal obstruction or perforation may occur); in patients with gastrointestinal ulcers (symptom exacerbation is possible).

Cases of intestinal obstruction and intestinal perforation have been reported with the use of sodium and calcium polystyrene sulfonates. In the event of phenomena such as severe constipation, prolonged abdominal pain, vomiting, it is necessary to discontinue use and take appropriate therapeutic measures. Patients should be advised to consult a doctor if they experience abdominal pain, abdominal distension, vomiting, and other symptoms characteristic of intestinal obstruction/perforation.

Like other cation exchange resins, Calcium polystyrene sulphonate is not selective for potassium cations. The development of hypomagnesemia and/or hypercalcemia is possible. Accordingly, during therapy, the levels of all measurable electrolytes should be monitored. Calcium levels should be assessed weekly for the early diagnosis of possible hypercalcemia and correction of the calcium polystyrene sulfonate dose to levels that do not cause hypercalcemia and hypokalemia.

In case of clinically significant constipation, treatment should be interrupted until normal intestinal peristalsis is restored. Magnesium-containing laxatives should not be used to treat constipation in such patients.

Since elderly patients often have reduced physiological process activity, closer medical supervision and the use of lower doses of the drug are recommended when prescribing calcium polystyrene sulfonate to elderly patients.

Drug Interactions

Concomitant use with sorbitol is not recommended, as cases of intestinal necrosis have been reported with such use.

Cation exchange drugs may reduce the effectiveness of potassium ion binding by this agent.

With the concomitant use of cation exchange resins and cation-containing antacid and laxative drugs (including magnesium hydroxide, aluminum hydroxide, calcium carbonate), the development of systemic alkalosis and the formation of aluminum hydroxide concretions are possible.

With concomitant use with digitalis preparations (e.g., digoxin), in case of hypokalemia and/or hypercalcemia, an increase in the toxic effect of digitalis preparations on the heart is possible, especially the occurrence of ventricular arrhythmias and suppression of the atrioventricular node.

With concomitant use with lithium preparations, a decrease in lithium absorption is possible.

With concomitant use with thyroxine, a decrease in thyroxine absorption is possible.

Calcium polystyrene sulphonate may impair the absorption of fat-soluble vitamins.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.