Description
Release form inside for oral suspension powder for administration
Pharmacological action
Metabolic
Pharmacodynamics:
Kalimeyt is a cation exchange resin of calcium polystyrenesulfonate. After oral administration in 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.
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 KC1 solution). When applying the total daily dose of 15-30 g / day to patients suffering from renal failure (adults), the level of serum potassium decreases by about 1 mEq / L. Unlike sodium-containing cation exchange resins, Kalimeyt does not lead to an increase in serum sodium and phosphate levels and a decrease in serum calcium levels in patients with renal failure. Since Kalimeyt is a calcium-containing cation exchange resin, the drug can be used even in patients with limited sodium intake. In addition, Kalimeyt can be used without risk of occurrence and increased severity of arterial hypertension, heart failure, edema caused by the introduction of sodium.
Pharmacokinetics:
The drug is not absorbed and excreted in the feces as an unchanged polystyrenesulfonate resin.
However, there is evidence that particles smaller than 5 microns were absorbed through the mucous membrane and deposited in the tissues of the reticuloendothelial system. For this reason, the content in the preparation of particles with a diameter of less than 5 microns 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.
Contraindications
1) Intestinal obstruction
2) Hypersensitivity to polystyrenesulfonate in the anamnesis of
3) Conditions, accompanied by hypercalcemia (for example, hyperparathyroidism, multiple myeloma, sarcoidosis, metastatic carcinoma)
4) Plasma potassium levels below 5 mmol / l
5) Kalimeyt is not recommended for use in children under the age of 18 due to insufficient data on the effectiveness and
safety 6) Co-administration with sorbitol.
Precautions:
1) In patients prone to constipation (risk of bowel obstruction or perforation)
2) In patients with bowel stenosis (possible bowel obstruction or perforation)
3) In patients with gastrointestinal ulcers (possible exacerbation of symptoms).
Pregnancy and lactation
No specific safety studies of calcium polystyrenesulfonate during pregnancy have been conducted. The drug is not used in newborns, so its appointment to patients with hyperkalemia during lactation is not recommended.
Special instructions
Cases of intestinal obstruction and perforation of the intestine have been reported with sodium and calcium polystyrenesulfonates. In the event of phenomena such 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 polystyrenesulfonate is not selective for potassium cations. Perhaps the development of hypomagnesemia and / or hypercalcemia. Accordingly, with drug therapy, the levels of all electrolytes available for determination should be monitored. Calcium levels should be evaluated weekly for early diagnosis of possible hypercalcemia and dose adjustment of polystyrenesulfonate calcium to levels that do not cause hypercalcemia and hypokalemia.
In the case of clinically significant constipation, treatment should be discontinued until normal intestinal motility is restored. Magnesium-containing laxatives should not be used to treat constipation in such patients.
Since elderly patients often have a decrease in the activity of physiological processes, when prescribing calcium polystyrenesulfonate, elderly patients are advised to carry out closer medical supervision and apply lower doses of the drug.
Influence on the 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 conducted.
Composition
1 g of powder contains:
Active ingredient
calcium polystyrenesulfonate – 1 g
Dosage and administration of
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 juices rich in potassium – orange, pineapple, grape, tomato) per 1 g of powder. If necessary, the prepared suspension can be introduced using a gastric probe 2-3 mm thick. When preparing the suspension, inhalation of the drug should be avoided because of the risk of developing acute bronchitis (see section Side effects).
The above dose is average and can be individually adjusted depending on the electrolyte levels in a particular patient. The use of calcium polystyrenesulfonate should be discontinued with a decrease in potassium levels below 5 mmol / L.
Elderly patients (over 65 years old)
Since elderly patients often have a decrease in the activity of physiological processes, when prescribing calcium polystyrenesulfonate, elderly patients are advised to carry out closer medical supervision and apply smaller doses of the drug.
Side effects
The incidence of side effects is indicated by the World Health Organization (WHO) recommended classification of indicators:
Very often:> 1/10 Frequently: 1/100 Infrequently: 1/1000 Rarely: 1/10000 Very rarely:
Violations from the side of metabolism and nutrition
Often: hypokalemia, anorexia
Infrequently: hypercalcemia
Rarely: hypomagnesemia
Disorders of the gastrointestinal tract
Often: constipation, nausea, stomach discomfort, anorexia, sardlk rdl.
Rarely: intestinal perforation, ischemic colitis or intestinal necrosis, intestinal obstruction. The formation of calculi (bezoars) in the gastrointestinal tract after the use of the drug was reported.
Disorders of the respiratory system, chest and mediastinal organs
Rarely: cases of the development of acute bronchitis and / or bronchopneumonia associated with inhalation of calcium polystyrenesulfonate particles have been reported.
Disorders of the skin and subcutaneous tissue
Rarely: rash
If these side effects are aggravated or if new ones not described in the instructions appear, the patient should inform the doctor.
Drug Interactions
The combined use of the drug with sorbitol is not recommended, since cases of intestinal necrosis have been reported with such use.
Cation exchange drugs may decrease the potency of potassium ion binding with Kalimeyt.
with the combined use of cation-exchange resins and cation-containing antacid and laxatives (magnesium hydroxide, aluminum hydroxide, calcium carbonate, etc.), systemic alkalosis and the formation of aluminum hydroxide calculi are possible.
When used together with digitalis preparations (e.g., digoxin), in the case of hypokalemia and / or hypercalcemia, the toxic effect of digitalis preparations on the heart may increase, especially the occurrence of ventricular arrhythmias and inhibition of the atrioventricular node.
When used together with lithium preparations, lithium absorption may be reduced.
When combined with thyroxine, thyroxine absorption may be reduced.
Calcium polystyrenesulfonate may impair the absorption of fat-soluble vitamins.
Overdose
Overdose biochemical disorders can cause clinical manifestation of symptoms of hypokalemia (irritability, confusion, slowing thinking, muscle weakness, hyporeflexia, paralysis). As 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 using laxatives and enemas.
Storage conditions
Store in a dry place at a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Term hodnosty
3 years
active substance
Calcium polystyrenesulfonate
Terms leave through pharmacies
In retseptu
