Calcium gluconate-SOLOPHARM, 100 mg/ml 10 ml 10 pcs

Pharmacotherapeutic group

Calcium-phosphorus metabolism regulator.

The ATC code: A12AA03

Pharmacological properties

Pharmacodynamics

The calcium drug replenishes the deficiency of calcium ions necessary for the process of transmission of nerve impulses, contraction of skeletal and smooth muscles, myocardial activity, formation of bone tissue, and blood clotting.

In intravenous administration it stimulates the sympathetic section of the autonomic nervous system, increases adrenal adrenal secretion.

Pharmacokinetics

After parenteral administration of calcium gluconate with blood flow is evenly distributed in all tissues and organs. In blood plasma calcium is both in bound form (complexed with proteins and with anions of organic and inorganic acids (bicarbonate, phosphate, lactate, calcium citrate)) and in free ionized form.

It penetrates the placental barrier and enters breast milk. It is eliminated from the body mainly by the kidneys.

Indications

Treatment of acute hypocalcemia.

Active ingredient

Calcium gluconate

Composition

1 ml of the drug contains:

Active ingredient:

Calcium gluconate monohydrate 94 mg

Assisted substances:

Calcium saccharate 5 mg

Injection water up to 1 ml

How to take, the dosage

The normal serum concentration of total calcium is 2.25-2.75 mmol/l, or 4.45-5.5 sEq/l. Therapy with calcium gluconate is aimed at restoring normal plasma calcium concentration. Calcium-containing solutions should be administered slowly to minimize peripheral vasodilation and cardiac suppression.

The drug is heated to body temperature before administration. The drug is administered deeply intramuscularly or intravenously slowly (over 2-3 minutes), or dropwise, to avoid the possibility of local irritation or necrosis if the drug enters the perivascular tissues. Intravenous injections should be performed under close monitoring of heart rate and electrocardiogram, since bradycardia with vasodilation and arrhythmias may occur if calcium gluconate is administered too rapidly.

Intravenous administration may cause fever throughout the body, which passes quickly.

Because of the risk of local irritation, intramuscular injections should only be performed if intravenous injection is not possible. Intramuscular injections should be made deep enough into the muscle, preferably in the gluteal area. For obese patients, a longer needle should be selected to inject safely into the muscle rather than into the fatty tissue. If repeated injections are necessary, the injection site should be changed each time.

Adults: deeply intramuscularly, intravenously slowly (within 2-3 minutes) or by drip 5-10 ml of 100 mg/ml (10% solution) daily, every other day or every 2 days (depending on the character of the disease and the patient’s clinical condition). Subsequent doses are determined in accordance with the concentration of calcium in blood serum.

In children under 18 years of age: the dose and method of administration depend on the degree of hypocalcemia, the nature and severity of symptoms.

In children, depending on their age, the drug in a concentration of 100 mg/ml (10% solution) is administered in the following doses: up to 6 months, 0.1-1 ml; 7-12 months, 1-1.5 ml; 1-3 years –

1.5-2 ml; 4-6 years – 2-2.5 ml; 7-14 years – 3.5 ml; over 14 years – doses as for adults. Children should not receive the drug intramuscularly because of the possible development of necrosis. Only slow intravenous injection or intravenous infusion after dilution is recommended in order to achieve sufficiently low rates of administration and to avoid the possibility of local irritation or necrosis if the drug accidentally enters the perivascular tissues.

For intravenous infusion the drug is diluted 1:10 to a concentration of 10 mg/ml with the following solutions for infusion: 0.9% sodium chloride solution or 5% glucose solution. The rate of intravenous injection should not exceed 50 mg of calcium gluconate per minute. Dilution should be performed under aseptic conditions.

Elderly patients: There are no data indicating adverse tolerance of calcium gluconate in elderly patients; however, age-related changes such as impaired renal function and slowed metabolism may require dose reduction.

Polymer ampoule procedure:

– Take the ampoule and shake it by holding the neck.

– Rotate and separate the valve.

– Immediately connect the luer of the syringe to the ampoule through the hole that is created.

– Draw the contents of the ampoule into the syringe.

Place the needle on the syringe.

Interaction

Symptoms of hypercalcemia: anorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, renal calcification, drowsiness, hypersomnia, confusion, increased blood pressure, in severe cases – arrhythmia (up to heart failure) and coma.

Treatment: aimed at reducing the increased concentration of calcium in the blood plasma. Initial therapy includes rehydration, in severe hypercalcemia may require intravenous sodium chloride 0.9% solution infusion to increase the amount of extracellular fluid. Calcitonin may be used to decrease serum calcium concentration.

Furosemide may be used to increase calcium excretion, but “thiazide” diuretics should not be used because they may increase renal calcium absorption. Hemodialysis or peritoneal dialysis is performed if other measures are ineffective or if symptoms of hypercalcemia persist. Treatment of overdose is carried out under careful control of serum electrolyte concentration.

Special Instructions

The drug is heated to body temperature before administration. The drug is injected deeply intramuscularly or intravenously slowly (within 2-3 minutes), or dropwise, to avoid the possibility of local irritation or necrosis if the drug enters the perivascular tissues. Intravenous injections should be performed under close monitoring of heart rate and electrocardiogram, since bradycardia with vasodilation and arrhythmias may occur if calcium gluconate is administered too rapidly.

Intravenous administration may cause fever throughout the body, which passes quickly.

Because of the risk of local irritation, intramuscular injections should only be performed if intravenous injection is not possible. Intramuscular injections should be made deep enough into the muscle, preferably in the gluteal area. For obese patients, a longer needle should be selected to inject safely into the muscle rather than into the fatty tissue. If repeated injections are necessary, the injection site should be changed each time.

In intravenous administration of calcium gluconate, in exceptional cases, patients receiving cardiac glycosides need cardiac monitoring and conditions for urgent treatment of cardiac complications (such as severe arrhythmias) must be provided.

Calcium salts should be used with caution and only after careful indication in patients with nephrocalcinosis, cardiovascular disease, sarcoidosis (Beck disease), in patients receiving epinephrine, in elderly patients.

The impairment of renal function may be associated with hypercalcemia and secondary hyperparathyroidism. Therefore, in patients with impaired renal function parenteral administration of calcium should be administered only after careful determination of parameters, and calcium-phosphate balance should be monitored.

In case of concomitant use with other medicinal products the supervision of a physician is required.

The solution should only be used if it is clear and the ampoule is not damaged. The drug is diluted immediately after opening the ampoule. When diluting the drug, strict adherence to the rules of asepsis is required. From the point of view of microbiological safety, the diluted drug must be used immediately. The ampoule is for single use only. Exceptions are dilutions prepared under controlled aseptic conditions. Once the solution has been prepared, the terms and conditions of storage prior to administration are the responsibility of the user and should not exceed 24 hours at 2 to 8 °C. Remaining unused volumes of the drug must be disposed of.

The effect on the ability to drive:

During treatment with the drug, care must be taken when performing potentially hazardous activities requiring increased concentration and rapid psychomotor reactions (driving vehicles, operating moving machinery, dispatcher and operator work).

Contraindications

Hypersensitivity to calcium gluconate and other drug components, hypercalcemia (including patients with hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal failure, osteoporosis associated with immobilization, sarcoidosis, lactic-alkali syndrome (Burnett syndrome)), hypercalciuria, intoxication with cardiac glycosides, concurrent treatment with cardiac glycosides; For intramuscular administration – pediatric age.

With caution

. Dehydration, electrolyte disorders (risk of hypercalcemia), diarrhea, malabsorption syndrome, calcium nephrolithiasis (history), mild hypercalciuria, moderate chronic renal failure, common atherosclerosis, hypercoagulability, in elderly patients, especially in the presence of one or more of the above mentioned conditions, nephrocalcinosis, cardiovascular pathology, sarcoidosis, chronic heart failure, concomitant treatment with epinephrine. It is necessary to consult a physician before using the drug.

Side effects

The incidence of side effects is directly related to the rate of administration and the dose of calcium gluconate. When properly administered, the frequency of their occurrence is 1/1000.

Cardiovascular system: decreased blood pressure, bradycardia, arrhythmia, vasodilation, circulatory collapse (including lethal), “flushes” of blood, most often with rapid administration.

Digestive system disorders: nausea, vomiting, diarrhea.

General disorders: feeling of warmth, sweating.

Disorders at the site of injection: with intramuscular injection – pain or erythema (≤ 1/10, ≥ 1/100), with violation of the technique of intramuscular injection – infiltration into fatty tissue with subsequent formation of abscess, thickening of tissues and necrosis; with intravenous injection – skin flushing, burning sensation or pain with possible development of tissue necrosis (with accidental perivascular injection).

A case of soft tissue calcification with subsequent possible skin lesions and necrosis due to calcium release from the vessel into the tissue has been reported.

Overdose

Symptoms of hypercalcemia: anorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, renal calcification, drowsiness, hypersomnia, confusion, increased blood pressure, in severe cases – arrhythmia (up to heart failure) and coma.

Treatment: aimed at reducing the increased concentration of calcium in the blood plasma. Initial therapy includes rehydration, in severe hypercalcemia may require intravenous sodium chloride 0.9% solution infusion to increase the amount of extracellular fluid. Calcitonin may be used to decrease serum calcium concentration.

Furosemide may be used to increase calcium excretion, but “thiazide” diuretics should not be used because they may increase renal calcium absorption. Hemodialysis or peritoneal dialysis is performed if other measures are ineffective or if symptoms of hypercalcemia persist. Treatment of overdose is carried out under careful control of serum electrolyte concentration.

Similarities

Calcium gluconate, Calcium gluconate Renewal, Calcium gluconate-SOLOPHARM