Powder for the preparation of the suspension for oral administration is crystalline, from white with a yellowish tinge to a light yellow color, odorless; after mixing with water, a homogeneous suspension of yellowish-white or light-yellow color is formed, precipitation may occur; with manual shaking, the particles easily pass into the slurry.
1 g
calcium polystyrene sulfonate 1 g
5 g - packages from the combined material (21) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Kalimate is a cation-exchange resin, calcium polystyrene sulfonate. After oral administration to the gastrointestinal tract, the calcium cation of the resin is released into the blood, replacing the potassium cation from the patient's blood (mainly in the large intestine), which explains the therapeutic effect of the drug with hyperkalemia.
In dry matter it contains 7.0-9.0% calcium, 1 g of the drug replaces 53-71 mg (1.36-1.82 mEq / g) of potassium in vitro (in KCl solution). When using a total daily dose of 15-30 g / day patients suffering from kidney failure (adults), the serum potassium level decreases by approximately 1 mEq / L. Unlike sodium-containing cation-exchange resins, Kalimate does not lead to an increase in serum sodium and phosphate levels and a decrease in serum calcium in patients with renal insufficiency. Because Kalimate is a calcium-containing cation-exchange resin, the drug can be used even in patients with limited sodium intake. In addition, Kalimate can be used without the risk of appearance and increased severity of arterial hypertension, heart failure, edema caused by the introduction of sodium.
PHARMACOKINETICS
The drug is not absorbed and is excreted with feces in the form of unaltered resin polystyrene sulfonate.
However, there are data that particles smaller than 5 Ојm were absorbed through the mucosa and deposited in the tissues of the reticuloendothelial system. For this reason, the content in the preparation with a diameter of less than 5 Ојm is subject to mandatory control and amounts to 0.1% of the total volume of the preparation.
INDICATIONS
- Hyperkalemia caused by acute or chronic renal failure.
DOSING MODE
Adult patients
The standard daily dose is 15-30 g, which should be divided into 2-3 doses. The drug is diluted in a small amount of water (30-50 ml) or 3-4 ml of sweet food or liquid (except for the juices rich in potassium - orange, pineapple, grape, tomato) per 1 g of powder. If necessary, the prepared suspension can be introduced with a 2-3 mm thick gastral probe. When preparing the suspension, the inhalation of the drug should be avoided because of the risk of developing acute bronchitis (see section "Side effect").
The above dose is average, and can be individually adjusted depending on the electrolyte levels of the individual patient. The use of calcium polystyrene sulfonate should be discontinued when the potassium level drops below 5 mmol / l.
Patients of advanced age (over 65 years)
Because in patients of advanced age, a decrease in the activity of physiological processes is often observed, with the appointment of calcium polystyrene sulfonate to elderly patients recommended to carry out more intensive medical supervision and apply lower doses of the drug.
SIDE EFFECT
The incidence of side effects is indicated by the classification of indicators recommended by the World Health Organization (WHO): very often -> 1/10; often - <1/10> 1/100; infrequently - <1/100> 1/1000; rarely - <1/1000> 1/10 000; very rarely - <1/10 000.
From the side of metabolism and nutrition: often - hypokalemia, anorexia; infrequently - hypercalcemia; rarely - hypomagnesemia
From the digestive tract: often - constipation, nausea, discomfort in the stomach, anorexia; infrequently - vomiting, diarrhea; rarely - perforation of the intestine, ischemic colitis or necrosis of the intestine, intestinal obstruction. It was reported the formation of concrements (bezoars) in the gastrointestinal tract after application of the drug.
On the part of the respiratory system, chest and mediastinum: rarely - reported cases of development of acute bronchitis and / or bronchopneumonia associated with the inhalation of calcium particles polystyrene sulfonate.
From the skin and subcutaneous tissues: rarely - rash
If these side effects are aggravated or if new ones not described in the instructions appear, the patient should inform the doctor about it.
CONTRAINDICATIONS
- intestinal obstruction;
- a history of hypersensitivity to polystyrene sulfonate;
- conditions accompanied by hypercalcemia (eg, hyperparathyroidism, multiple myeloma, sarcoidosis, metastatic carcinoma);
- the level of potassium in the plasma is below 5 mmol / l;
- not recommended for use in children under the age of 18 due to insufficient data on efficacy and safety;
- combined use with sorbitol.
Carefully
- in patients prone to constipation (the risk of intestinal obstruction or perforation);
- in patients with intestinal stenosis (there may be intestinal obstruction or perforation);
- in patients with gastrointestinal ulcers (possibly exacerbation of symptoms).
PREGNANCY AND LACTATION
Special studies of the safety of calcium polystyrene sulfonate in pregnancy have not been conducted. The drug is not used in newborns, so its appointment to patients with hyperkalemia during lactation is not recommended.
APPLICATION FOR CHILDREN
Contraindicated use of the drug for children and adolescents under the age of 18 due to lack of data on efficacy and safety.
APPLICATION IN ELDERLY PATIENTS
Elderly patients are recommended to perform more intensive medical supervision and apply smaller doses of the drug.
SPECIAL INSTRUCTIONS
Cases of intestinal obstruction and perforation of the intestine with the use of sodium and calcium polystyrene sulfonates have been reported. In the case of such phenomena as severe constipation, prolonged abdominal pain, vomiting, it is necessary to stop using the drug and take appropriate therapeutic measures. Patients should be advised to consult a doctor in case of abdominal pain, bloating, vomiting and other symptoms characteristic of intestinal obstruction / perforation of the intestine.
Like other cation-exchange resins, calcium polystyrene sulfonate is not selective for potassium cations. Possible development of hypomagnesemia and / or hypercalcemia. Accordingly, when the drug is administered, the levels of all electrolytes available for detection should be monitored. Calcium levels should be assessed weekly for early diagnosis of possible hypercalcemia and correction of the calcium dose of polystyrene sulfonate to levels that do not cause hypercalcaemia and hypokalemia.
In the case of clinically significant constipation, treatment should be discontinued until normal intestinal peristalsis recovers. Do not use magnesium-containing laxatives to treat constipation in these patients.
Because in patients of advanced age, a decrease in the activity of physiological processes is often observed, with the appointment of calcium polystyrene sulfonate to elderly patients recommended to carry out more intensive medical supervision and apply lower doses of the drug.
Influence on ability to drive vehicles and work with mechanisms
Studies of the effect of the drug on the ability to drive a car and work with mechanisms have not been carried out.
OVERDOSE
Biochemical disorders in overdose can cause a clinical manifestation of symptoms of hypokalemia (irritability, confusion, slowing of thinking, muscle weakness, hyporeflexia, paralysis). When the condition progresses, respiratory arrest may develop. Electrocardiographic changes may correspond to those characteristic of hypokalemia or hypercalcemia, arrhythmias may develop. Adequate measures should be taken to correct plasma electrolyte levels and remove the drug from the digestive tract with the help of laxatives and enemas.
DRUG INTERACTION
It is not recommended joint use of the drug with sorbitol , t. reported cases of development of intestinal necrosis in this application.
Cation-exchange drugs can reduce the efficiency of binding of potassium ions with Kalimeit.
With the joint use of cation-exchange resins and cation- containing antacid and laxatives (magnesium hydroxide, aluminum hydroxide, calcium carbonate, etc.), it is possible to develop systemic alkalosis and the formation of concretions of aluminum hydroxide.
When combined with digitalis preparations (for example, digoxin), in the case of hypokalemia and / or hypercalcemia, the toxic effect of digitalis preparations on the heart, especially the occurrence of ventricular arrhythmias and the inhibition of the atrioventricular node, may increase.
When combined with lithium preparations, it is possible to reduce absorption of lithium.
When combined with thyroxine , a decrease in thyroxine absorption is possible.
Calcium polystyrene sulfonate can impair the absorption of fat-soluble vitamins.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years
Do not use after the expiration date.
