Instructions for Calcium Gluconate-Darnitsa tablets 500 mg No. 10
Composition
active ingredient: calcium gluconate;
1 tablet contains calcium gluconate 500 mg;
excipients: potato starch, colloidal anhydrous silicon dioxide, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a slightly yellowish tint, flat-cylindrical shape, with a bevel and a score.
Pharmacotherapeutic group
Mineral supplements. Calcium preparations.
Calcium gluconate. ATX 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 clotting processes; they are necessary for the formation of bone tissue and the normal functioning of other systems and organs. The concentration of calcium ions in the blood decreases in many pathological processes; severe hypocalcemia contributes to the occurrence of tetany. Calcium gluconate, in addition to eliminating hypocalcemia, reduces vascular permeability, has anti-allergic, anti-inflammatory, hemostatic effects, and also reduces exudation. Calcium ions are a plastic material for the skeleton and teeth, participate in various enzymatic processes, regulate the speed of nerve impulse conduction and the permeability of cell membranes. Calcium ions are necessary for the process of neuromuscular transmission, to maintain the contractile function of the myocardium. Unlike calcium chloride, calcium gluconate has a weaker local irritant effect.
Pharmacokinetics
When taken orally, calcium gluconate is partially absorbed, mainly in the small intestine. The maximum concentration in blood plasma is reached after 1.2-1.3 hours. The half-life of ionized calcium from blood plasma is 6.8-7.2 hours. Penetrates through the placental barrier and into breast milk. Excreted from the body with urine and feces.
Indication
Diseases accompanied by hypocalcemia, increased permeability of cell membranes, and impaired conduction of nerve impulses in muscle tissue.
Hypoparathyroidism (latent tetany, osteoporosis), vitamin D metabolism disorders (rickets, spasmophilia, osteomalacia), hyperphosphatemia in patients with chronic renal failure.
Increased need for calcium (period of intensive growth of children and adolescents; pregnancy, breastfeeding), insufficient calcium content in food, impaired calcium metabolism in the postmenopausal period, bone fracture.
Increased calcium excretion (prolonged bed rest, chronic diarrhea, hypocalcemia with prolonged use of diuretics, antiepileptic drugs, glucocorticosteroids).
In complex therapy: bleeding of various etiologies; allergic diseases (serum sickness, urticaria, feverish syndrome, pruritic dermatoses, angioedema); bronchial asthma, dystrophic alimentary edema, pulmonary tuberculosis, eclampsia, parenchymal hepatitis, toxic liver lesions, nephritis.
As an antidote for poisoning with magnesium salts, oxalic acid, soluble salts of hydrofluoric acid (when interacting with calcium gluconate, insoluble and non-toxic calcium oxalate and calcium fluoride are formed).
Contraindication
Hypersensitivity to the components of the drug, hypercalcemia, severe hypercalciuria, hypercoagulation, tendency to thrombosis, severe atherosclerosis, increased blood clotting, nephrourolithiasis (calcium), severe renal failure, sarcoidosis, taking 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 preparations (the interval between their administrations should be at least 3 hours). Calcium gluconate reduces the bioavailability of phenytoin. When taken simultaneously with vitamin D or its derivatives, calcium absorption increases. Cholestyramine reduces calcium absorption in the digestive tract. When used together with cardiac glycosides, the cardiotoxic effects of the latter are enhanced. When combined with thiazide diuretics, the risk of hypercalcemia may increase. Calcium gluconate may reduce the effect of calcitonin in hypercalcemia, the bioavailability of phenytoin, the effect of calcium channel blockers. When used simultaneously with quinidine, intraventricular conduction may slow down and quinidine toxicity may increase. Forms insoluble or sparingly soluble calcium salts with carbonates, salicylates, and sulfates.
Some foods (spinach, rhubarb, bran, grains) can reduce calcium absorption from the gastrointestinal tract.
Application features
When used in patients receiving cardiac glycosides and/or diuretics, as well as during long-term treatment, the concentration of calcium and creatinine in the blood should be monitored. In case of an increase in their concentration, the dose of the drug should be reduced or its use should be temporarily discontinued. Due to the fact that vitamin D3 increases the absorption of calcium from the digestive tract, in order to avoid calcium overdose, it is necessary to take into account the intake of vitamin D3 and calcium from other sources.
With caution and with regular monitoring of the level of urinary calcium excretion, prescribe to patients with moderate hypercalciuria exceeding 300 mg/day (7.5 mmol/day), not sharply expressed renal dysfunction, urolithiasis in history. If necessary, the dose of the drug should be reduced or canceled. Patients with a tendency to the formation of stones in the urinary tract during treatment are recommended to increase the volume of fluid consumed.
When treating with the drug, high doses of vitamin D or its derivatives should be avoided, unless there are special indications for this.
An interval of at least 3 hours should be observed between taking calcium gluconate tablets and oral preparations of estramustine, etidronate and other bisphosphonates, phenytoin, quinolones, tetracycline antibiotics, oral iron preparations and fluoride preparations.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving or working with other mechanisms.
Use during pregnancy or breastfeeding
The use of the drug is permissible taking into account the benefit-risk ratio for the woman/fetus (child), which is determined by the doctor.
When taking calcium supplements during breastfeeding, it is possible for it to pass into breast milk.
Method of administration and doses
The tablet must be chewed or crushed.
Calcium gluconate is taken orally before meals.
Single doses: adults and children over 14 years old – 1-3 g (2-6 tablets), children from 3 to 4 years old – 1 g (2 tablets), from 5 to 6 years old – 1-1.5 g (2-3 tablets), from 7 to 9 years old – 1.5-2 g
(3-4 tablets), from 10 to 14 years – 2-3 g (4-6 tablets). Take 2-3 times a day.
The daily dose for elderly patients should not exceed 2 g (4 tablets).
The duration of treatment is determined by the doctor individually depending on the patient's condition.
Children
The medicine should be used in children over 3 years of age.
Overdose
With prolonged use in high doses, hypercalcemia with deposition of calcium salts in the body is possible. The likelihood of developing hypercalcemia increases with simultaneous treatment 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 arrhythmias, myalgia, arthralgia, arterial hypertension.
Treatment: drug withdrawal; in severe cases, parenteral calcitonin at a dose of 5-10 IU/kg body weight per day (diluting it in 500 ml of 0.9% sodium chloride solution), intravenously drip for 6 hours. Slow intravenous jet injection 2-4 times a day is possible).
Adverse reactions
The drug is usually well tolerated, but sometimes there may be violations:
Gastrointestinal: nausea, vomiting, constipation, diarrhea, epigastric pain; with prolonged use in high doses - formation of calcium stones in the intestines;
Kidney and urinary system: renal dysfunction (frequent urination, swelling of the lower extremities);
Metabolic: hypercalcemia, hypercalciuria;
Cardiovascular system: bradycardia;
Immune system disorders: hypersensitivity reactions, including allergic reactions.
These phenomena quickly disappear after reducing the dose or discontinuing the drug.
Expiration date
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 contour blister packs.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
