Calcium gluconate

INSTRUCTIONS for medical use of the medicinal product CALCIUM GLUCONATE

Composition:

Active substance: calcium gluconate.

1 tablet contains calcium gluconate, recalculated to 100 % substance – 500 mg;

Excipients: potato starch, sodium croscarmellose, talc, calcium stearate.

Pharmaceutical form. Tablets.

Main physical and chemical properties: white, flat cylindrical tablets 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 nerve impulse transmission, 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 and exerts antiallergic, anti-inflammatory, hemostatic effects, and decreases exudation. Calcium ions serve as a structural component for bones and teeth, participate in various enzymatic processes, and regulate the rate of nerve impulse conduction and cell membrane permeability. Calcium ions are necessary for neuromuscular transmission and for maintaining myocardial contractile function. 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 half-life of ionized calcium in plasma is 6.8–7.2 hours. It crosses the placental barrier and is excreted into breast milk. Elimination from the body occurs via urine and feces.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the components of the drug, hypercalcemia, pronounced hypercalciuria, hypercoagulation (increased blood coagulation), predisposition to thrombosis, severe atherosclerosis, nephrolithiasis (calcium type), severe renal failure, sarcoidosis, concomitant use of digitalis preparations.

Interaction with other medicinal products and other types of interactions.

The drug slows down 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). Calcium gluconate reduces the bioavailability of phenytoin. When taken simultaneously with vitamin D or its derivatives, calcium absorption is enhanced. Cholestyramine reduces calcium absorption in the gastrointestinal tract. Concurrent use of the drug with cardiac glycosides enhances the cardiotoxic effects of the latter. Glucocorticosteroids reduce calcium absorption. Combined use with thiazide diuretics increases the risk of developing hypercalcemia. The drug may reduce the effect of calcitonin in hypercalcemia, reduce phenytoin bioavailability, and diminish the effect of calcium channel blockers. Simultaneous use with quinidine may lead to 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.

When administering to patients receiving cardiac glycosides and/or diuretics, as well as during prolonged treatment, serum calcium and creatinine concentrations should be monitored. If their concentrations increase, the dose of the drug should be reduced or its administration 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.

Calcium gluconate should be administered with caution to patients with mild hypercalciuria (more than 300 mg/day = 7.5 mmol/day), mild renal function impairment, or a history of calcium urolithiasis, and urinary calcium excretion should be monitored regularly. If necessary, the dose should be reduced or the drug discontinued. Patients predisposed to formation of urinary calculi should be advised to increase fluid intake during treatment.

During treatment with this drug, concomitant use of high doses of vitamin D or its derivatives should be avoided unless specifically indicated.

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

Use during pregnancy or breastfeeding.

Use of the drug is permissible only if the benefit to the woman outweighs the potential risk to the fetus (or child), as determined by the physician. Calcium preparations may pass into breast milk during lactation.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration.

The medication should be taken orally before meals. The tablet should be chewed or crushed.

For adults and children aged 14 years and older, the single dose is 1–3 g (2–6 tablets); for children aged 3 to 4 years – 1 g (2 tablets), aged 5 to 6 years – 1–1.5 g (2–3 tablets), aged 7 to 9 years – 1.5–2 g (3–4 tablets), 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) per day.

The duration of treatment is determined individually by a physician, depending on the patient's condition.

Children. The medication is indicated for children aged 3 years and older.

Overdose.

Prolonged use at high doses may lead to hypercalcemia with calcium salt deposition in tissues. Gastrointestinal disturbances may also occur. The risk of developing hypercalcemia increases when concomitantly treated 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, possible cardiac rhythm disturbances, myalgia, arthralgia, arterial hypertension.

Treatment: discontinue the drug; in severe cases – parenteral administration of calcitonin at a dose of 5–10 IU/kg body weight per day (diluted in 500 ml of sterile physiological saline solution, administered intravenously by infusion over 6 hours). Alternatively, slow intravenous bolus injection 2–4 times daily may be used.

Adverse Reactions.

The drug is usually well tolerated, but the following disturbances may occasionally occur:

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

Cardiovascular system: bradycardia;

Metabolic disorders: hypercalcemia, hypercalciuria;

Urinary system: impaired kidney function (frequent urination, edema of lower extremities).

Allergic reactions are possible.

These effects rapidly disappear after dose reduction or discontinuation of the drug.

Shelf life. 8 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

500 mg tablets, 10 in a strip; 10 in a blister, 1 blister per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "Kyivmedpreparat". JSC "Halychpharm".

Manufacturer's address and location of business activity.

JSC "Kyivmedpreparat", Ukraine, 01032, Kyiv, Saksaganskoho St., 139.

JSC "Halychpharm", Ukraine, 79024, Lviv, Opryshkovska St., 6/8.

INSTRUCTION

for medical use of medicinal product

CALCIUM GLUCONATE

(CALCIUM GLUCONATE)

Composition:

Active substance: calcium gluconate.

One tablet contains calcium gluconate, calculated as 100% substance – 500 mg;

Excipients: potato starch, sodium croscarmellose, talc, calcium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical properties: white, flat cylindrical tablets with a score line and beveled edges.

Pharmacotherapeutic group. Calcium preparations.

ATC code A12AA03.

Pharmacological properties.

Pharmacodynamics.

Calcium gluconate is a calcium salt of gluconic acid containing 9% calcium. Calcium ions are involved in nerve impulse transmission, contraction of smooth and skeletal muscles, myocardial function, blood coagulation processes; they are essential for bone tissue formation and normal functioning of other organs and systems. Blood calcium ion concentration 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, hemostatic effects, and decreases exudation. Calcium ions serve as a structural material for bones and teeth, participate in various enzymatic processes, regulate the speed of nerve impulse conduction and cell membrane permeability. Calcium ions are necessary for neuromuscular transmission and maintenance of myocardial contractile function. Compared to calcium chloride, calcium gluconate has a weaker local irritant effect.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Conditions associated with hypocalcemia, increased cellular membrane permeability, and impaired nerve impulse conduction in muscle tissue. Hypoparathyroidism (latent tetany, osteoporosis), vitamin D metabolism disorders (rickets, tetany, osteomalacia), hyperphosphatemia in patients with chronic renal failure. Increased calcium demand (periods of rapid growth in children and adolescents, pregnancy, breastfeeding), insufficient dietary Ca²⁺ intake, metabolic disturbances in the postmenopausal period, bone fractures. Increased Ca²⁺ excretion (prolonged bed rest, chronic diarrhea, hypocalcemia during long-term use of diuretics, antiepileptic drugs, glucocorticosteroids). In complex therapy: hemorrhages of various etiologies, allergic diseases (serum sickness, urticaria, febrile syndrome, pruritic dermatoses, angioneurotic edema); bronchial asthma, dystrophic alimentary edema, pulmonary tuberculosis, eclampsia, parenchymal hepatitis, toxic liver damage, nephritis. Poisoning with magnesium salts, oxalic acid, or soluble fluorides (calcium gluconate forms insoluble and non-toxic calcium oxalate and calcium fluoride).

Contraindications.

Hypersensitivity to the components of the drug, hypercalcemia, marked hypercalciuria, hypercoagulability (increased blood coagulation), predisposition to thrombosis, marked atherosclerosis, nephrolithiasis (calcium type), severe renal failure, sarcoidosis, concomitant use of cardiac glycosides.

Interaction with other medicinal products and other types 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 administrations should be at least 3 hours). Calcium gluconate reduces the bioavailability of phenytoin. Concurrent use with vitamin D or its derivatives increases calcium absorption. Cholestyramine reduces calcium absorption in the gastrointestinal tract. Concomitant use with cardiac glycosides enhances their cardiotoxic effects. Glucocorticosteroids reduce calcium absorption. Combined use with thiazide diuretics increases the risk of hypercalcemia. The drug may reduce the effect of calcitonin in hypercalcemia, reduce phenytoin bioavailability, and diminish the effect of calcium channel blockers. Concurrent use with quinidine may slow intraventricular conduction and increase 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.

In patients receiving cardiac glycosides and/or diuretics, and during prolonged treatment, serum calcium and creatinine levels should be monitored. If their concentrations increase, the dose should be reduced or treatment 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.

Calcium gluconate should be administered with caution in patients with mild hypercalciuria (more than 300 mg/day = 7.5 mmol/day), mild renal dysfunction, or a history of kidney stones, with regular monitoring of urinary calcium excretion. If necessary, the dose should be reduced or the drug discontinued. Patients prone to urinary stone formation should increase fluid intake during treatment.

High-dose vitamin D or its derivatives should be avoided during treatment unless specifically indicated.

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

Use during pregnancy or breastfeeding.

Use of the drug is permissible based on the benefit-risk ratio for the mother and fetus (child), as determined by the physician. Calcium preparations may pass into breast milk during lactation.

Ability to affect reaction speed when driving or operating machinery.

The drug does not affect reaction speed when driving vehicles or operating machinery.

Administration and dosage.

Administer orally before meals. The tablet should be chewed or crushed.

Adults and children over 14 years: single dose of 1–3 g (2–6 tablets); children aged 3–4 years: 1 g (2 tablets); 5–6 years: 1–1.5 g (2–3 tablets); 7–9 years: 1.5–2 g (3–4 tablets); 10–14 years: 2–3 g (4–6 tablets), 2–3 times daily. The daily dose for elderly patients should not exceed 2 g (4 tablets).

Duration of treatment is determined individually by the physician, depending on the patient's condition.

Children. The drug is indicated for children aged 3 years and older.

Overdose.

Prolonged use in high doses may cause hypercalcemia with calcium salt deposition in tissues; dyspeptic symptoms may occur. The risk of hypercalcemia increases with concomitant high-dose vitamin D or its derivatives.

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

Treatment: discontinue the drug; in severe cases – parenteral administration of calcitonin 5–10 IU/kg body weight per day (diluted in 500 ml of sterile sodium chloride physiological solution, administered intravenously by drip over 6 hours. Slow intravenous bolus injection may be used 2–4 times daily).

Adverse reactions.

The drug is usually well tolerated, but the following disturbances may occasionally occur:

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

Cardiovascular system: bradycardia;

Metabolic disorders: hypercalcemia, hypercalciuria;

Urinary system: impaired kidney function (frequent urination, edema of lower extremities).

Allergic reactions are possible.

These effects rapidly disappear after dose reduction or discontinuation of the drug.

Shelf life. 8 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

500 mg tablets, 10 in a strip; 10 in a blister, 1 blister per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC "Kyivmedpreparat". JSC "Halychpharm".

Manufacturer's address and location of business activity.

JSC "Kyivmedpreparat", Ukraine, 01032, Kyiv, Saksaganskoho St., 139.

JSC "Halychpharm", Ukraine, 79024, Lviv, Opryshkovska St., 6/8.