Calcium gluconate

I N S T R U C T I O N for medical use of the medicinal product CALCIUM GLUCONATE (CALCII GLUCONAS)

Composition:

Active substance: calcium gluconate; calcium salt of gluconic acid;

1 tablet contains calcium gluconate 0.5 g;

Excipients: calcium stearate, potato starch, sodium bicarbonate.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white tablets with a matte shade, flat surface, with a score line and chamfer.

Pharmacotherapeutic group. Calcium preparations. ATC code A12A A03.

Pharmacological Properties

Pharmacodynamics

Calcium gluconate is a calcium salt of gluconic acid containing 9% calcium. Calcium ions are involved in the transmission of nerve impulses, contraction of smooth and skeletal muscles, myocardial function, and blood coagulation processes; they are essential for bone tissue formation and normal functioning of other organs and systems. The concentration of calcium ions in blood decreases in many pathological conditions; pronounced hypocalcemia may lead to tetany. In addition to correcting hypocalcemia, calcium gluconate reduces vascular permeability, exerts antiallergic, anti-inflammatory, and hemostatic effects, and decreases exudation. Calcium ions serve as a structural material for bones and teeth, participate in various enzymatic processes, and regulate the speed of nerve impulse conduction and cell membrane permeability. Calcium ions are necessary for neuromuscular transmission and for maintaining the contractile function of the myocardium. Unlike calcium chloride, calcium gluconate has a weaker local irritant effect.

Pharmacokinetics

When administered orally, calcium gluconate is partially absorbed, primarily in the small intestine. Maximum plasma concentration is reached within 1.2–1.3 hours. The elimination half-life of ionized calcium from blood plasma is 6.8–7.2 hours. It crosses the placental barrier and is excreted into breast milk. Calcium is eliminated from the body via urine and feces.

Clinical characteristics.

Indications. Conditions associated with hypocalcemia, increased cellular membrane permeability, and impaired conduction of nerve impulses in muscular tissue. Hypoparathyroidism (latent tetany, osteoporosis), disturbances in vitamin D metabolism (rickets, tetany, osteomalacia), hyperphosphatemia in patients with chronic renal failure. Increased calcium requirements (periods of rapid growth in children and adolescents, pregnancy, lactation), insufficient dietary Ca2+ intake, impaired calcium metabolism in the postmenopausal period, bone fractures. Enhanced calcium excretion (prolonged bed rest, chronic diarrhea, hypocalcemia during long-term use of diuretics, antiepileptic drugs, glucocorticoids). In complex therapy: hemorrhages of various etiologies, allergic disorders (serum sickness, urticaria, angioedema, pruritic dermatoses, anaphylactic reactions); bronchial asthma, dystrophic nutritional edemas, pulmonary tuberculosis, eclampsia, parenchymal hepatitis, toxic liver injury, nephritis. Poisoning with magnesium salts, oxalic acid, and soluble salts of hydrofluoric acid (when interacting with calcium gluconate, insoluble and non-toxic calcium oxalate and calcium fluoride are formed).

Contraindications.

• Hypersensitivity to the components of the drug.
• Hypercalcemia.
• Severe hypercalciuria.
• Hypercoagulability.
• Tendency to thrombosis.
• Severe atherosclerosis.
• Nephrolithiasis (calcium type).
• Severe renal failure.
• Sarcoidosis.
• Concomitant use of cardiac glycosides.

Special precautions.

When administered to patients receiving cardiac glycosides and/or diuretics, or during prolonged treatment, serum calcium and creatinine concentrations should be monitored. If these concentrations increase, the dose should be reduced or the drug temporarily discontinued. Since vitamin D3 enhances calcium absorption from the gastrointestinal tract, to avoid calcium overdose, intake of vitamin D3 and calcium from other sources must be taken into account.

Use 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 urolithiasis. If necessary, reduce the dose or discontinue the drug. Patients prone to stone formation in the urinary tract should increase fluid intake during treatment.

During treatment with this drug, avoid taking high doses of vitamin D or its derivatives unless specifically indicated.

An interval of at least 3 hours should be maintained between administration of calcium gluconate tablets and oral estramustine, etidronate, other bisphosphonates, phenytoin, quinolones, tetracycline antibiotics, oral iron preparations, and fluoride-containing drugs.

Interaction with other medicinal products and other forms of interactions.

The drug slows the absorption of estramustine, etidronate, and other bisphosphonates, quinolones, tetracycline antibiotics, oral iron preparations, and fluoride-containing drugs (the interval between their administration should be at least 3 hours). The drug delays phenytoin absorption. Glucocorticoids reduce calcium absorption in the gastrointestinal tract. Concurrent use with vitamin D or its derivatives increases calcium absorption. Cholestyramine reduces calcium absorption in the gastrointestinal tract. Concurrent use with cardiac glycosides enhances the cardiotoxic effects of the latter. Combination with thiazide diuretics increases the risk of hypercalcemia. The drug may reduce the effect of calcitonin in hypercalcemia, decrease phenytoin bioavailability, and diminish the effect of calcium channel blockers. Concurrent use with quinidine may result in slowed intraventricular conduction and increased quinidine toxicity.

Forms insoluble or poorly soluble calcium salts with carbonates, salicylates, and sulfates.

Calcium absorption from the gastrointestinal tract may be reduced by certain foods (spinach, rhubarb, bran, cereals).

Special precautions for use.

Use during pregnancy or breastfeeding.

The use of the medicinal product is permissible based on the benefit to the woman versus the risk to the fetus (child), as determined by a physician.

Calcium preparations taken during breastfeeding may be excreted in breast milk.

Ability to influence reaction speed when driving or operating machinery.

The drug does not affect the ability to drive vehicles or operate machinery.

Dosage and Administration.

Calcium gluconate should be taken orally before meals in the following single doses: adults and children aged 14 years and older – 1–3 g (2–6 tablets); children aged 3 to 4 years – 1 g (2 tablets); children aged 5 to 6 years – 1–1.5 g (2–3 tablets); children aged 7 to 9 years – 1.5–2 g (3–4 tablets); children aged 10 to 14 years – 2–3 g (4–6 tablets), 2–3 times daily. The daily dose for elderly patients should not exceed 2 g (4 tablets). The duration of treatment is determined individually by a physician, depending on the patient's condition. The tablet should be chewed or crushed.

Children.

There is no experience with the use of the drug in children under 3 years of age.

Overdose.

Prolonged use at high doses may lead to hypercalcemia with calcium salt deposition in the body; dyspeptic symptoms are possible. The risk of developing hypercalcemia increases when the drug is used concomitantly with high doses of vitamin D or its derivatives.

Symptoms of hypercalcemia: drowsiness, weakness, anorexia, abdominal pain, vomiting, nausea, constipation, polydipsia, polyuria, increased fatigue, irritability, malaise, depression, dehydration; cardiac rhythm disturbances, myalgia, arthralgia, and arterial hypertension are possible.

Treatment: discontinue the drug; in severe cases – parenteral administration of calcitonin at a dose of 5–10 IU/kg body weight per day (dissolve in 500 ml of sterile physiological sodium chloride solution, administer intravenously by infusion over 6 hours. Slow intravenous bolus injection 2–4 times daily is also possible).

Side effects.

The drug is usually well tolerated, but the following adverse reactions may occur:

Cardiovascular system: bradycardia;

Metabolic disorders: hypercalcemia, hypercalciuria;

Gastrointestinal tract: nausea, vomiting, diarrhea, epigastric pain, constipation; with prolonged use at high doses – formation of calcium concretions in the intestine;

Urinary system: impaired kidney function (increased urination, swelling of lower extremities).

Occasionally, allergic reactions may occur.

These symptoms quickly resolve after dose reduction or discontinuation of the drug.

Shelf life. 5 years.

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

Keep out of reach of children.

Packaging. 10 tablets per strip or blister.

10 tablets per blister. 3 or 10 blisters per cardboard box.

Supply category. Over-the-counter.

Manufacturer. JSC "Monfarm".

Manufacturer's address and location of business activity.

8, Zavodska St., Avramivka, Uman district, Cherkasy region, 19161, Ukraine.