Properties
What is it?
Dosage form: Powder for preparation of oral suspension Description: Whitish-yellowish-green powder with lemon flavor. Composition: 1 sachet contains: Active substance: Calcium (in the form of Calcium Carbonate DC) 1000 mg, Vitamin D3 (Cholecalciferol) 880 IU (22 mcg). Excipients: Alpha-tocopherol, Maltodextrin, Modified food starch, Medium-chain triglycerides, Crystalline sodium ascorbate, Sucrose, Silicon dioxide, Anhydrous citric acid, Lemon flavoring, Potassium acesulfame, Aspartame. ATC code: A12AX Pharmacological group: Calcium in combination with other drugs Pharmacological properties Pharmacodynamics Combined preparation that regulates calcium and phosphorus metabolism, especially in bone tissue. It reduces resorption (calcium leaching from bones) and increases bone tissue density in the body, replenishing calcium and vitamin D3 deficiency. The action of the preparation is determined by the effect of its components. Calcium participates in bone tissue formation, tooth mineralization, regulation of nerve conduction and muscle contraction, maintenance of stable heart function, and is a component of the blood coagulation system. Vitamin D3 enhances calcium absorption in the intestines and its binding in bone tissue, and regulates calcium and phosphorus metabolism in the body. The use of calcium and vitamin D3 inhibits the production of parathyroid hormone (PTH), which is a stimulant of increased bone resorption (calcium leaching from bones). Pharmacokinetics Calcium: The amount of calcium normally absorbed in the gastrointestinal tract is approximately 30% of the administered dose. 99% of calcium in the body is in the solid structure of bones and teeth, and the remaining 1% is in intracellular and extracellular fluids. Approximately 50% of the total calcium content in the blood is in the physiologically active ionized form, of which approximately 10% is in complex with citrates, phosphates, or other anions, and the remaining 40% is bound to proteins, primarily albumin. Calcium is excreted by the intestines, kidneys, and sweat glands. Vitamin D3: Vitamin D3 is easily absorbed in the small intestine (approximately 80% of the administered dose). Cholecalciferol is converted in the liver via hydroxylation to 25-hydroxycholecalciferol. Then, in the kidneys, it is converted to the active form - 1,25-hydroxycholecalciferol. 1,25-hydroxycholecalciferol is a metabolite responsible for increasing calcium absorption. Unmetabolized vitamin D3 is deposited in adipose and muscle tissue. Vitamin D3 is excreted by the intestines and kidneys. Indications for use Deficiency or prophylaxis of vitamin D3 and calcium; prophylaxis and complex treatment of osteoporosis (menopausal, senile, steroid) in patients with vitamin D3 and calcium deficiency; bone fractures, slowing of post-traumatic regeneration processes of bone tissue. Method of administration and dosage The contents of the sachet should be well dissolved in a glass of water and taken immediately after preparation, preferably during meals. As a prophylactic agent: 1 sachet per day. In complex treatment of osteoporosis: 1 sachet per day. To replenish vitamin D3 and calcium deficiency: 1-2 sachets per day. The daily dose of the preparation is individual depending on the patient's condition and may vary according to the doctor's prescription. The duration of treatment is determined individually by the doctor. Contraindications Hypersensitivity to any component of the preparation; hypercalcemia, hypercalciuria; vitamin D3 hypervitaminosis; urolithiasis (nephrolithiasis); chronic renal failure; active tuberculosis; sarcoidosis. Side effects Gastrointestinal system: Constipation, meteorism, nausea, gastralgia, diarrhea. Metabolism system: Hypercalciuria and hypercalcemia during prolonged treatment with increased doses. Special instructions With prolonged use of the preparation, monitoring of calcium levels in blood serum and urine, as well as kidney function monitoring by determining creatinine, is recommended. Monitoring is especially important for elderly patients who are already using cardiac glycosides or diuretics. In case of signs of hypercalcemia or renal failure, it is necessary to reduce the dose of the preparation or discontinue its intake. If the calcium level in urine exceeds 7.5 mmol per 24 hours (300 mg per 24 hours), it is recommended to shorten or temporarily stop treatment. The use of the preparation is not recommended in combination with vitamin-mineral complexes containing calcium and vitamin D3. It should be taken into account that additional intake of vitamin D3 from other sources is possible. In patients with renal failure, impaired metabolism of vitamin D3 is observed. If such patients take cholecalciferol, it is necessary to check its effect on calcium and phosphate homeostasis. Effect on ability to drive vehicles and work with mechanisms: No negative effect is expected. Pregnancy and lactation During pregnancy, the daily dose should not exceed 1,500 mg of calcium and 600 IU of vitamin D3. It is possible to take an incomplete dose of the preparation Calcidvit (half of the prepared solution). Vitamin D3 and its degradation products pass into breast milk. Calcidvit can be used during lactation. Use in children In children from 3 years of age, the preparation can be taken according to the recommended daily dose, by proportional division of the prepared solution. Interaction with other medicinal products Concomitant use of phenytoin and barbiturates may reduce the effect of vitamin D3 through metabolic inactivation. In simultaneous treatment with cardiac glycosides, it is necessary to monitor ECG and clinical condition, as calcium preparations can potentiate the therapeutic and toxic effects of cardiac glycosides. When taken orally with bisphosphonates, sodium fluoride, or tetracyclines, it is recommended to use the preparation only 3 hours later (there is a risk of reduced absorption of bisphosphonates, sodium fluoride, or tetracyclines). In case of use with thiazide diuretics, the risk of developing hypercalcemia increases, as they increase tubular reabsorption of calcium. Furosemide and other loop diuretics, on the contrary, increase the excretion of calcium by the kidneys. The use of the preparation with glucocorticosteroids may lead to a decrease in calcium absorption. Foods containing oxalates (sorrel, spinach) and phytin (cereals) reduce calcium absorption, so Calcidvit should not be taken within 2 hours of consuming sorrel, spinach, and cereals. Overdose Symptoms: Anorexia, thirst, polyuria, decreased appetite, dizziness, weakness, nausea, vomiting, hypercalciuria, hypercalcemia; hypercreatininemia; with prolonged use of overdose - calcification of blood vessels and tissues. Treatment: Seek medical attention. Administration of large amounts of fluid into the body, prescription of loop diuretics, glucocorticosteroids, calcitonin, bisphosphonates. Packaging Powder for preparation of oral suspension in sachets of 3.6g. 30 sachets are placed in a box with instructions. Special storage conditions: Store in a dry place, at a temperature not exceeding 25ºC. Keep out of reach of children. Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Dispensing conditions: Pharmaceutical product group III, available without a prescription. Manufacturer: S.C. „Slavia Pharm SRL”