Calcium gluconate

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALCIUM GLUCONATE (CALCIUM GLUCONATE)

Composition:

active substance: calcium gluconate;

1 ml of solution contains calcium gluconate 95.5 mg (1 ml of the preparation contains 8.95 mg of total calcium (Ca2+), which, recalculated to the theoretical content of calcium gluconate, is equivalent to 100 mg/ml);

excipients: calcium saccharate, water for injections.

Pharmaceutical form. Solution for injection.

Main physico-chemical properties: clear, colorless liquid.

Pharmacotherapeutic group. Calcium preparations. ATC code A12AA03.

Pharmacological Properties.

Pharmacodynamics.

Calcium gluconate (stabilized) is an agent that regulates metabolic processes and replenishes calcium deficiency in the body; it exerts hemostatic, antiallergic effects and reduces capillary permeability.

Calcium ions are involved in the transmission of nerve impulses, contraction of smooth and skeletal muscles, myocardial function, and blood coagulation; they are essential for bone tissue formation and the functioning of other systems and organs. The concentration of calcium ions in the blood decreases in many pathological conditions, and pronounced hypocalcemia promotes the development of tetany. Calcium gluconate eliminates hypocalcemia, reduces vascular permeability, and exerts antiallergic, anti-inflammatory, and hemostatic effects.

Pharmacokinetics.

After parenteral administration, the drug is evenly distributed via the bloodstream throughout all tissues and organs. In blood plasma, calcium is present in ionized form. It crosses the placental barrier and enters breast milk. It is mainly excreted from the body by the kidneys.

Clinical characteristics.

Indications.

Hypoparathyroidism; increased calcium excretion from the body; as an adjunctive agent in allergic diseases (serum sickness, urticaria, angioedema) and allergic complications of drug therapy; to reduce vascular permeability in pathological processes of various origins (exudative phase of inflammation, hemorrhagic vasculitis, radiation sickness); parenchymal hepatitis; toxic liver damage; nephritis; eclampsia; hyperkalemia; hyperkalemic form of periodic paralysis; skin diseases (skin pruritus, eczema, psoriasis); as a hemostatic agent; as an antidote in poisoning with magnesium salts, oxalic acid or its soluble salts, and soluble salts of hydrofluoric acid.

Contraindications.

Hypersensitivity to the components of the drug; predisposition to thrombosis; hypercalcemia; severe hypercalciuria; pronounced atherosclerosis; increased blood coagulation; severe renal failure; sarcoidosis; concomitant use with cardiac glycosides and ceftriaxone.

Aluminum oxide may leach from glass ampoules into calcium gluconate solution; therefore, to limit aluminum exposure, especially in patients with impaired renal function and children (under 18 years), calcium gluconate should not be used for the preparation of total parenteral nutrition.

Repeated and prolonged treatment is contraindicated in children (under 18 years) and patients with impaired renal function (due to the risk of aluminum toxicity).

Hypercalcemia (e.g., hyperparathyroidism, hypervitaminosis D, tumor diseases with bone decalcification).

Calcium gluconate must not be administered concomitantly with ceftriaxone due to the risk of forming an insoluble ceftriaxone-calcium complex, in the following cases:

• preterm newborns aged ≤ 41 weeks postmenstrual age (gestational age + postnatal age);
• term newborns (aged ≤ 28 days).

Interaction with other medicinal products and other types of interactions.

Ethanol interacts with calcium gluconate, causing the latter to precipitate.

Concomitant administration with other calcium-containing drugs is not recommended.

Intravenous administration of calcium gluconate before and after verapamil reduces its antihypertensive effect, but does not affect its antiarrhythmic effect.

Combination with thiazide diuretics may lead to the development of hypercalcemia.

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

Parenteral administration of calcium gluconate is not recommended during treatment with cardiac glycosides due to enhanced cardiotoxic effects.

Concomitant oral administration of calcium gluconate and tetracyclines may reduce the efficacy of the latter due to decreased absorption.

Calcium gluconate reverses neuromuscular blockade induced by aminoglycoside antibiotics.

Calcium-containing drugs may reduce the effectiveness of phenytoin when used concomitantly.

Special precautions for use.

Calcium salts should be administered with caution to patients with impaired renal function or heart disease.

When administering to patients receiving cardiac glycosides and/or diuretics, as well as during prolonged treatment, serum calcium and creatinine levels should be monitored, especially in children. If their concentrations increase, the dose should be reduced or the drug temporarily discontinued.

Calcium supplements should be prescribed with caution and under regular monitoring of urinary calcium excretion in patients with moderate hypercalciuria exceeding 300 mg/day (7.5 mmol/day), mild renal dysfunction, or a history of nephrolithiasis. If necessary, the dose should be reduced or the drug discontinued. To reduce the risk of nephrolithiasis, adequate fluid intake is recommended.

Serum calcium levels and urinary calcium excretion should be monitored, especially in children and in patients with chronic renal insufficiency or nephrolithiasis. If plasma calcium exceeds 2.75 mmol/L or daily urinary calcium excretion exceeds 5 mg/kg, treatment must be immediately discontinued due to the risk of cardiac arrhythmias.

Before filling the syringe with calcium gluconate solution, ensure that no residual ethanol is present, as interaction between ethanol and calcium gluconate may cause precipitation of calcium gluconate.

Serious complications, including fatal outcomes, have occurred due to microcrystallization of insoluble calcium salts in the body following separate administration of physically incompatible solutions or total parenteral nutrition solutions containing calcium and phosphates.

Fatal reactions due to formation of ceftriaxone-calcium precipitates in the lungs and kidneys have been reported in premature and full-term neonates up to 1 month of age.

Scientific publications report cases of intravascular precipitate formation in patients of various ages (excluding neonates) who were treated with ceftriaxone and intravenous solutions containing calcium, or any other calcium-containing products. In vitro studies have shown that neonates have an increased risk of ceftriaxone-calcium precipitation compared to other age groups.

Ceftriaxone must not be mixed or administered simultaneously with intravenous solutions containing calcium.

However, in patients aged 28 days and older, ceftriaxone and calcium-containing solutions may be administered sequentially, provided that infusion is performed at different sites or the infusion system is replaced between administrations to prevent precipitate formation.

Use during pregnancy or breastfeeding.

The use of this medicinal product during pregnancy or breastfeeding is possible only if the benefit to the mother outweighs the potential risk to the fetus (or infant).

Calcium passes into breast milk, which should be taken into account when administering the drug to breastfeeding women.

Ability to affect driving or operating machinery.

There is no data indicating a negative effect of the medicinal product on the ability to drive or operate machinery.

Administration and Dosage.

Administer intravenously or intramuscularly.

For adults and children aged 14 years and older, administer 5–10 mL of a 10% solution once daily. Depending on the nature of the disease and the patient's condition, administration may be performed daily, every other day, or every two days.

For children, the 10% calcium gluconate solution is administered intravenously according to the following age-dependent dosage: under 6 months of age – 0.1–1 mL; 6–12 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.

The solution should be warmed to body temperature before administration. In adults and children, the solution should be administered slowly over 2–3 minutes.

For volumes less than 1 mL, the single dose should be adjusted by dilution with 0.9% isotonic sodium chloride solution or 5% glucose solution to the appropriate volume (syringe volume).

Children.

Intramuscular administration of the drug is not recommended in children under 14 years of age due to the risk of developing necrosis.

Overdose.

Symptoms: hypercalcemia may develop. Symptoms of hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, polydipsia, polyuria, mental disturbances, nephrocalcinosis, nephrolithiasis, and in severe cases, cardiac arrhythmias and 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 administered 2–4 times daily. Use non-thiazide diuretics; monitor serum potassium and magnesium concentrations and administer potassium and magnesium preparations if necessary; monitor cardiovascular function and administer beta-blockers to prevent arrhythmias. Hemodialysis may be performed if necessary.

Side effects.

Nausea, vomiting, diarrhea, bradycardia, sensation of warmth in the mouth followed by warmth throughout the whole body, and skin reactions may occasionally occur. These reactions resolve quickly on their own.

When administered rapidly, nausea, vomiting, increased sweating, feeling of heaviness in the head, syncope, general weakness, arterial hypotension, vasomotor collapse, and sometimes fatal outcomes are possible. Extravasation of calcium solution may lead to soft tissue calcification.

Very rarely, allergic and anaphylactic reactions up to anaphylactic shock may occur.

Intramuscular injections of calcium salts may cause local irritation.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging. Do not refrigerate. Keep out of reach of children.

Incompatibility.

Pharmaceutically incompatible with ethyl alcohol, oxidizing agents, citric acid, carbonates, bicarbonates, phosphates, salicylates, sulfates, and tartrates.

Physical incompatibility with amphotericin, cephalothin solution, cefamandole, ceftriaxone, novobiocin sodium, dobutamine hydrochloride, prochlorperazine, and tetracycline.

Packaging.

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

Prescription status. Prescription only.

Manufacturer. LLC "Yuria-Pharm".

Manufacturer's address and location of business activity.

108, Kobzarska Street, Cherkasy, Cherkasy region, 18030, Ukraine.

Tel.: (044) 281-01-01.