Calcium chloride

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALCIUM CHLORIDE (CALCIUM CHLORIDE)

Composition:

Active substance: calcium chloride;

1 ml of solution contains calcium chloride dihydrate 100 mg;

Excipient: water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Plasma substitutes and perfusion solutions. Electrolyte solutions.

ATC code B05X A07.

Pharmacological properties.

Pharmacodynamics.

The medicinal product Calcium chloride eliminates calcium ion deficiency. Calcium ions are involved in the transmission of nerve impulses, contraction of smooth and skeletal muscles, myocardial functional activity, and blood coagulation; they are necessary for bone tissue formation and the functioning of other systems and organs. The concentration of calcium ions in blood decreases due to many pathological processes; pronounced hypocalcemia promotes the development of tetany. Calcium chloride, in addition to correcting hypocalcemia, reduces vascular permeability and exhibits hemostatic action.

Intravenous administration of calcium causes stimulation of the sympathetic nervous system, enhancing norepinephrine release.

Pharmacokinetics.

In blood, calcium exists in both bound and ionized forms. Physiological activity is inherent to ionized calcium. It is deposited in bone tissue. Excreted by the kidneys (20%) and through the intestine (80%). 95% of calcium undergoing glomerular filtration is reabsorbed.

Clinical characteristics.

Indications.

Cases of hypocalcemia requiring rapid increase in plasma calcium ion concentration (tetany due to parathyroid insufficiency, tetany due to vitamin D deficiency, hypocalcemia during exchange transfusion and infusion of citrate blood, alkalosis). Acute lead colic — as part of complex therapy. Cases of magnesium intoxication occurring due to magnesium overdose. Hyperkalemia, registered on ECG as cardiac function disturbance.

Contraindications.

Hypersensitivity to the components of the drug, hypercalcemia, marked hypercalciuria, nephrolithiasis (calcium), severe renal failure, sarcoidosis, hypercoagulability, tendency to thrombosis.

Marked atherosclerosis with signs of arterial occlusion. Ventricular fibrillation. Asystole and electromechanical dissociation. Concomitant use of cardiac glycosides.

Concomitant administration with ceftriaxone.

Interaction with other medicinal products and other types of interactions.

Currently, there are no reliable scientific data on the occurrence of intravascular precipitates in patients (except neonates) when ceftriaxone and calcium-containing medicinal products are used concomitantly. However, it is not recommended to use solvents containing calcium, or to mix or administer ceftriaxone and calcium-containing medicinal products simultaneously in any patient population. Calcium-containing solutions should not be administered within 48 hours after the last dose of ceftriaxone.

Calcium-containing products may reduce the effectiveness of calcium channel blockers, diminish the effect of calcitonin in hypercalcemia, and reduce phenytoin bioavailability.
Calcium salts reduce the absorption of certain medicinal products, such as bisphosphonates, fluorides, some fluoroquinolones, and tetracyclines; administration should be spaced at least 3 hours apart.

Calcium chloride reduces the cardiotonic effects of dobutamine.

Concomitant use with quinidine may result in slowed intraventricular conduction and increased quinidine toxicity.

When used concomitantly with cardiac glycosides, the cardiotoxic effects of the latter are enhanced.

Calcium salts must not be mixed with carbonates, phosphates, sulfates, or tartrates in parenteral mixtures.

Thiazide diuretics reduce calcium excretion in urine, increasing the risk of hypercalcemia.

Concomitant use with vitamin D or its derivatives increases calcium absorption.

Concomitant use with other calcium- or magnesium-containing medicinal products increases the risk of hypercalcemia or hypermagnesemia, respectively, especially in patients with chronic renal failure.

The medicinal product reduces the efficacy of non-depolarizing muscle relaxants. It may prolong the action of tubocurarine chloride.

Special precautions.

Prolonged use in high doses may lead to hypercalcemia with calcium salt deposition in the body.

The injection should be administered through a thin needle into a large vein to minimize the damaging effect of the drug on the vessel wall. The solution should be warmed to body temperature.

A common reaction to intravenous administration of the drug is a sensation of warmth in the mouth, followed by a feeling of warmth throughout the body.

Calcium chloride must not be administered subcutaneously or intramuscularly due to its irritant and necrotizing effects. In case of accidental extravasation of the solution into subcutaneous tissue or muscle, calcium chloride should be aspirated with a syringe if possible; 10 ml of 25% sodium sulfate injection solution or 5–10 ml of 25% magnesium sulfate injection solution should be injected into the injection site. Dimedrol should be administered to counteract resorptive effects; in cases of hypercalcemia, ethylenediaminetetraacetic acid (EDTA) should be used.

Use with caution in patients with mild to moderate chronic renal insufficiency, dehydration, electrolyte imbalances (risk of hypercalcemia), heart diseases (risk of arrhythmia), kidney disorders, patients with nephrolithiasis or conditions associated with hypercalcemia (particularly malignancies and sarcoidosis), in cor pulmonale, respiratory acidosis, and respiratory failure (risk of toxic reactions due to oxidation of calcium chloride). Careful monitoring of blood calcium levels is required during treatment.

Rapid intravenous administration may cause moderate reduction in arterial blood pressure due to vasodilation.

Calcium chloride for injection should not be administered orally to children due to severe gastrointestinal irritation.

Injections in children should not be administered through the skin of the head.

Use during pregnancy or breastfeeding.

Adequate and well-controlled studies on the safety and efficacy of the drug in pregnant women have not been conducted. Use during pregnancy is possible only if the potential benefit to the mother outweighs the potential risk to the fetus.

The drug may be used during breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

Driving and operating machinery are contraindicated during treatment with this drug.

Administration and Dosage.

Calcium chloride is administered intravenously as a bolus (very slowly) or by intravenous infusion (slowly).

Adults.

Intravenous bolus injection: 5 ml of 10% solution administered at a rate of 1 ml/min.

Intravenous infusion: 5–10 ml of 10% solution diluted in 100–200 ml of 0.9% sodium chloride solution or 5% glucose solution; administer at a rate of 6–8 drops/min.

Exchange transfusion and transfusion of citrated blood: for adults and children, 30 mg (0.3 ml) per 100 ml of blood.

Tetany: 10 ml of 10% solution (1 g) over 10–30 minutes; if necessary, repeat after 6 hours.

Hypocalcemia: 500 mg to 1 g (5–10 ml) every 1 to 3 days, depending on patient response or plasma calcium levels. If necessary, a repeat dose may be administered.

Magnesium intoxication: 500 mg (5 ml) administered rapidly. Administration must be performed under medical supervision with monitoring of the patient's condition before administering subsequent doses.

Hyperkalemia, manifested on ECG as cardiac dysfunction: dosage should be individually adjusted according to the patient's condition, with continuous monitoring via electrocardiography.

Dosages for elderly patients are the same as those for adults.

Children.

Hypocalcemia: administer slowly at a rate of up to 0.5 ml/min, at a dose of 10–20 mg/kg body weight (0.1–0.2 ml/kg body weight), repeated every 4–6 hours if necessary.

Tetany: 10 mg/kg body weight (0.1 ml/kg body weight) over 5–10 minutes; if necessary, repeat after 6 hours or continue as infusions. Maximum daily dose for children (regardless of age) — 10 ml (1000 mg).

Children. Use in children is possible from the age of 1 year.

Overdose.

Symptoms of hypercalcemia: weakness, anorexia, abdominal pain, vomiting, nausea, constipation, polydipsia, polyuria, increased fatigue, irritability, malaise, depression, dehydration, possible cardiac rhythm disturbances, tachycardia, possible sudden drop in blood pressure and arterial hypertension, myalgia, arthralgia, coma.

Treatment: in cases of mild overdose (serum calcium concentration 2.6–2.9 mmol/L), discontinue administration and withdraw other calcium-containing medications. In cases of severe overdose (serum calcium concentration >2.9 mmol/L), administer calcitonin parenterally at a dose of 5–10 IU/kg body weight per day (diluted in 500 ml of 0.9% sodium chloride solution) by intravenous infusion over 6 hours. Slow intravenous bolus injections may be given 2–4 times daily. Use non-thiazide diuretics; monitor serum potassium and magnesium concentrations and, if necessary, administer potassium and magnesium preparations; monitor cardiovascular function and administer beta-adrenergic blockers to prevent arrhythmias. Hemodialysis may be required if necessary.

Adverse reactions.

From the sensory organs: chalky taste in the mouth.

From the metabolism and endocrine system: hypercalcemia.

From the psyche: depression.

From the cardiovascular system: moderate and transient decrease in arterial pressure, bradycardia, arrhythmia, arterial hypertension, venous thrombosis. With excessively rapid administration — ventricular fibrillation.

From the immune system: sensation of warmth, tingling starting in the oral cavity and then spreading throughout the body, facial skin hyperemia, allergic reactions, urticaria.

General disorders and administration site reactions: pain and hyperemia along the vein. In case of extravasation: burning sensation, tissue necrosis and eschar formation, cellulitis, and soft tissue calcification.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after registration of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 4 years.

Storage conditions. In the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility.

Pharmaceutically incompatible with tetracyclines, magnesium sulfate, ceftriaxone, and medicinal products containing phosphates, carbonates, or tartrates.

Calcium chloride should not be mixed in the same injection with ceftriaxone, as precipitate formation may occur.

Packaging.

5 ml or 10 ml in an ampoule; 5 ampoules in a blister pack; 2 blister packs in a carton.

Prescription status. Prescription only.

Manufacturer: JSC "Halychpharm".

Manufacturer's address and place of business.

6/8 Opryshkivska St., Lviv, 79024, Ukraine.