Calcium gluconate-darnitsa

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT KALSIYU HLYUKONAT-DARNITSA (CALCIUM GLUCONATE-DARNITSA)

Composition:

Active substance: calcium gluconate;

One tablet contains calcium gluconate 500 mg;

Excipients: potato starch, colloidal anhydrous silicon dioxide, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white or white with a slightly yellowish tint, flat cylindrical tablets, with a bevel and a score line.

Pharmacotherapeutic group. Mineral supplements. Calcium preparations.

Calcium gluconate. 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, 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 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 essential 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 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.

Diseases associated with hypocalcemia, increased cellular membrane permeability, and impaired conduction of nerve impulses in muscular tissue.

Hypoparathyroidism (latent tetany, osteoporosis), vitamin D metabolism disorders (rickets, tetany, osteomalacia), hyperphosphatemia in patients with chronic renal failure.

Increased calcium requirements (periods of intensive growth in children and adolescents; pregnancy, breastfeeding), insufficient dietary calcium intake, calcium metabolism disorders in the postmenopausal period, bone fractures.

Enhanced calcium excretion (prolonged bed rest, chronic diarrhea, hypocalcemia during prolonged 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 damage, nephritis.

As an antidote in 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, pronounced hypercalciuria, hypercoagulability, predisposition to thrombosis, severe atherosclerosis, increased blood coagulation, calcium-containing nephrolithiasis, 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 agents (the interval between their administration 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. When used concomitantly with cardiac glycosides, the cardiotoxic effects of the latter are enhanced. Combination with thiazide diuretics may increase the risk of hypercalcemia. Calcium gluconate may reduce the effect of calcitonin in hypercalcemia, the bioavailability of phenytoin, and 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, sulfates.

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

Special precautions for use.

When administered 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 medicinal product 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 nephrolithiasis. If necessary, the dose of the medicinal product 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 medicinal product, avoid concomitant administration of 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 formulations of estramustine, etidronate, and other bisphosphonates, phenytoin, quinolones, tetracycline antibiotics, oral iron preparations, and fluoride-containing products.

Use during pregnancy or breastfeeding.

Use of the medicinal product during pregnancy or breastfeeding is permissible only after careful assessment of the benefit-risk ratio for the mother and potential risk to the fetus (infant), as determined by the physician.

Calcium administered during lactation may pass into breast milk.

Ability to affect reaction speed when driving or operating machinery.

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

Method of administration and dosage.

The tablet should be chewed or crushed.

Calcium gluconate is administered orally before meals.

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); 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). Take 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 medicinal product should be administered to children aged 3 years and older.

Overdose.

Prolonged use in high doses may lead to hypercalcemia with deposition of calcium salts in the body. The risk of developing hypercalcemia increases when treating 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, possible cardiac rhythm disturbances, myalgia, arthralgia, arterial hypertension.

Treatment: discontinue the medicinal product; 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. Intravenous slow bolus injection may be used 2–4 times daily.

Adverse Reactions.

The medicinal product is generally well tolerated, but the following adverse effects may occasionally occur:

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

Renal and urinary system: impaired kidney function (frequent urination, swelling of the lower extremities);

Metabolic disturbances: hypercalcemia, hypercalciuria;

Cardiovascular system: bradycardia;

Immune system: hypersensitivity reactions, including allergic reactions.

These symptoms usually resolve quickly after dose reduction or discontinuation of the medicinal product.

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 a blister pack; 3 or 10 blisters per carton; 10 tablets in blister packs.

Dispensing category.

Over-the-counter – No. 10, No. 30; prescription only – No. 100.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Boryspylska Street, Kyiv, 02093, Ukraine.