Calcium gluconate-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALCIUM GLUCONATE-ZDOROV'YA

Composition:

Active substance: calcium gluconate;

1 tablet contains calcium gluconate 500 mg; |contains|

Excipients: calcium stearate, maize starch, sodium croscarmellose, crospovidone.

Pharmaceutical form. Tablets.

Main physicochemical properties: white, flat cylindrical tablets with a score line and beveled edges. Marbling on the tablet surface is permissible.

Pharmacotherapeutic group. Calcium preparations. ATC code A12AA03.

Pharmacological properties.

Pharmacodynamics. The drug replenishes relative or absolute calcium deficiency in the body. 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 the 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 decreases exudation. Calcium ions serve as a structural material for bones and teeth, participate in various enzymatic processes, regulate the rate 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 elimination half-life of ionized calcium from blood plasma is 6.8–7.2 hours. It crosses the placental barrier and passes into breast milk. It is excreted from the body via urine and feces.

Clinical characteristics.

Indications. Diseases associated with 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 requirements (periods of rapid growth in children and adolescents, pregnancy, lactation), inadequate dietary calcium 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, glucocorticosteroids). In complex therapy: hemorrhages of various etiologies, allergic diseases (serum sickness, urticaria, pruritic syndrome, pruritic dermatoses, angioneurotic edema); bronchial asthma, dystrophic alimentary edema, pulmonary tuberculosis, eclampsia, parenchymatous hepatitis, toxic liver damage, 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.
• Marked hypercalciuria.
• Hypercoagulability.
• Tendency to thrombosis.
• Severe 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 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). The drug slows down phenytoin absorption. Glucocorticosteroids reduce calcium absorption in the gastrointestinal tract. When taken concurrently with vitamin D or its derivatives, calcium absorption increases. Cholestyramine reduces calcium absorption in the gastrointestinal tract. Concurrent use of the drug with cardiac glycosides enhances the cardiotoxic effects of the latter. Combination with thiazide diuretics may increase the risk of developing hypercalcemia. The drug may reduce the effect of calcitonin in hypercalcemia, the bioavailability of phenytoin, and the effect of calcium channel blockers. Simultaneous 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.

When used in 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.

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 be advised to increase fluid intake during treatment.

During treatment with this drug, 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 this drug and oral esteramustine, etidronate and other bisphosphonates, phenytoin, quinolones, tetracycline antibiotics, oral iron preparations, and fluoride-containing products.

Use during pregnancy or breastfeeding.
Use of the drug is permissible based on the benefit-to-risk ratio for the woman and risk for the fetus (child), as determined by the physician.

When calcium-containing drugs are taken during breastfeeding, calcium may pass into breast milk.

Ability to influence reaction rate while driving or operating machinery.
The drug does not affect the ability to drive or operate machinery.

Method of administration and dosage.

Calcium gluconate should be taken orally before meals in a single dose: for adults and children aged 14 years and older – 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. 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 in high doses may lead to hypercalcemia with deposition of calcium salts 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, 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 (diluted in 500 ml of sterile 0.9% sodium chloride solution, administered intravenously by infusion over 6 hours). Alternatively, intravenous slow bolus injection 2–4 times daily may be used.

Adverse reactions

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

Cardiovascular system: bradycardia;

Metabolic disorders: hypercalcemia, hypercalciuria;

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

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

Occasionally, allergic reactions may occur.

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

Shelf life. 5 years.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. Tablets 500 mg: No. 10 (10×1), No. 100 (10×10) in blisters in a box; No. 10 in a blister.

Availability. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorov'ya".

Manufacturer's address. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.