CALCIUM GLUCONATE SOLUTION

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALCIUM GLUCONATE

Composition:

Active substance: calcium gluconate;

1 tablet contains calcium gluconate 500 mg;

Excipients: potato starch, talc, calcium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical properties: intact, regular, round cylindrical tablets with flat top and bottom surfaces, beveled edges, and a dividing score line, white in color. Marbling on the tablet surface is permissible.

Pharmacotherapeutic group.

Mineral supplements. 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 necessary for bone tissue formation and normal functioning of other systems and organs. The concentration of calcium ions in blood decreases in many pathological conditions; pronounced hypocalcemia promotes the development of tetany. In addition to correcting hypocalcemia, calcium gluconate reduces vascular permeability, exerts antiallergic, anti-inflammatory, and hemostatic effects, and also reduces 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 essential 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, mainly 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. It is 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 requirements (periods of rapid growth in children and adolescents, pregnancy or lactation), insufficient dietary Ca²⁺ intake, calcium metabolism disturbances in the postmenopausal period, bone fractures. Enhanced Ca²⁺ excretion (prolonged bed rest, chronic diarrhea, hypocalcemia during long-term use of diuretics, antiepileptic drugs, glucocorticoids). 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 injury, nephritis. As an antidote in 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, hypercoagulability, predisposition to thrombosis, advanced atherosclerosis, increased blood coagulation, 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 agents (the interval between administrations should be at least 3 hours). Calcium gluconate reduces the bioavailability of phenytoin. When taken concurrently with vitamin D or its derivatives, calcium absorption is enhanced. Cholestyramine reduces calcium absorption in the gastrointestinal tract. Concurrent use with cardiac glycosides increases their cardiotoxic effects. Glucocorticosteroids reduce calcium absorption. Combination with thiazide diuretics may increase 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 administration 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 for use.

When used in patients receiving cardiac glycosides and/or diuretics, as well as during long-term 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.

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 function impairment, or a history of urolithiasis. If necessary, the dose of the drug should be reduced or discontinued. Patients predisposed to formation of urinary calculi 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 and oral formulations of estramustine, etidronate, and other bisphosphonates, phenytoin, quinolones, tetracycline antibiotics, oral iron preparations, and fluoride-containing products.

Use during pregnancy or breastfeeding.

Use during pregnancy or breastfeeding is permissible only if the benefit to the woman outweighs the potential risk to the fetus (child), as determined by the physician.

Calcium preparations may pass into breast milk during lactation.

Ability to influence the speed of reactions while driving or operating machinery.

Does not affect.

Dosage and Administration.

Administer 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).

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

Children.

The drug is used in children from the age of 3 years.

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 with concomitant treatment using high doses of vitamin D or its derivatives.

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

Treatment: discontinue the drug; in severe cases – parenteral calcitonin at a dose of 5–10 IU/kg body weight per day (diluted in 500 ml of 0.9% sodium chloride solution), administered intravenously by infusion over 6 hours. Slow intravenous bolus injection may be used 2–4 times daily.

Adverse reactions.

The drug is usually well tolerated, but allergic reactions and other disturbances may occasionally occur:

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

Cardiovascular system: bradycardia;

Metabolism: hypercalcemia, hypercalciuria;

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

These symptoms quickly disappear 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 in blisters.

10 tablets per blister, 1 or 10 blisters per cardboard box.

Dispensing category.

Without prescription – № 10.

By prescription – № 100.

Manufacturer.

JSC "Lubnipharm".

Manufacturer's address and location of business activity.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.