Complivit Calcium D3 forte, mint 100 pcs.

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator.

ATC code: [A12AX].

Pharmacological properties

Pharmacodynamics

A combined drug whose action is due to its constituent components. It regulates calcium and phosphate metabolism, decreases resorption and increases bone density, compensates the lack of calcium and vitamin D₃ in the body, increases absorption of calcium in intestine and reabsorption of phosphate in kidneys, promotes bone mineralization.

Calcium is involved in the formation of bone tissue, blood clotting, in maintaining stable cardiac activity, in the processes of transmission of nerve impulses.

Vitamin D₃ (colecalciferol) – promotes the absorption of calcium in the intestine, the formation and mineralization of bone and dental tissue.

The use of calcium and vitamin D₃ prevents increased production of parathyroid hormone, which is a stimulant of increased bone resorption.

Pharmacokinetics

Vitamin D₃ is absorbed in the small intestine. Calcium is absorbed in ionized form in the proximal small intestine through an active, D-vitamin dependent transport mechanism.

Indications

Bone fragility, Strengthening of bones and joints

Prevention and comprehensive therapy of osteoporosis (menopausal, senile, “steroid”, idiopathic) and its complications (bone fractures).

Supplementation of calcium and/or vitamin D₃ deficiency.

Active ingredient

Calcium carbonate, Colecalciferol

Composition

Calcium 500 mg, (as calcium carbonate) 1.25 g

Calciferol (vitamin D₃) 0.01 mg (400 IU)

(in terms of 100% colocalciferol)

(as granulate, containing colocalciferol – 0,27 %, D,L-alpha-tocopherol – 0,0275 %, medium-chain triglycerides – 10,7 %, sucrose – 36 %, acacia gum – 22 %, corn starch – 27 %, calcium phosphate (E 341) – 0,5 %, water up to 100 %).

Auxiliary substances: Lactose monohydrate – 333.118 mg/333.118 mg, povidone (polyvinylpyrrolidone medium molecular weight, povidone K-30) – 68.24 mg/68.24 mg, polysorbate-80 – 0 mg/1.731 mg, potato starch – 18.969 mg/18.969 mg, croscarmellose sodium – 45,713 mg/50.282 mg, citric acid monohydrate – 3.325 mg/3.325 mg, aspartame (E 951) – 5.95 mg/5.95 mg, magnesium stearate – 15.75 mg/15.75 mg, orange flavoring – 8.925 mg or peppermint leaf oil – 2.625 mg.

How to take, the dosage

Over the mouth, chewed or swallowed whole, mostly with meals.

Adults: for the treatment of osteoporosis – 1 tablet 2-3 times a day, for the prevention of osteoporosis – 1 tablet 2 times a day.

For the replenishment of calcium and/or vitamin D₃ deficiency:

• Adults and children over 12 years – 1 tablet 1-2 times a day.

• Children from 3 to 12 years – 1 tablet per day or as prescribed by the doctor.

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Interaction

Vitamin D₃ activity may decrease when used concomitantly with phenytoin or barbiturates.

Concomitant treatment with cardiac glycosides requires ECG and clinical monitoring, because calcium preparations may potentiate therapeutic and toxic effects of cardiac glycosides.

Calcium and vitamin D preparations₃ may increase the absorption of tetracyclines from the gastrointestinal tract. Therefore, the time interval between doses should be at least three hours.

In order to prevent decreased absorption of bisphosphonates or sodium fluoride, it is recommended that Complivit^® Calcium D₃ Forte not be taken more than two hours after taking them.

Glucocorticosteroids decrease calcium absorption, therefore treatment with glucocorticosteroids may require increasing the dose of Complivit^® Calcium D₃ Forte.

Concomitant treatment with colestyramine preparations or mineral or vegetable oil-based laxatives may decrease vitamin D₃ absorption.

When thiazide-type diuretics are used concomitantly, the risk of hypercalcemia increases because they increase the tubular reabsorption of calcium. In contrast, furosemide and other “loop” diuretics increase calcium excretion by the kidneys.

Special Instructions

In order to avoid an overdose, additional vitamin D₃ intake from other sources must be considered.

Complivit^® Calcium D₃ Forte contains aspartame, which is transformed in the body into phenylalanine, so the drug should not be taken by patients suffering from phenylketonuria.

During treatment it is necessary to monitor constantly urinary calcium excretion and plasma calcium and creatinine concentrations (in case of calcium exceeding 7.5 mmol/day (300 mg/day), the dose should be reduced or the therapy should be stopped).

In the elderly, the need for calcium is 1500 mg/day, vitamin D₃ – 0.5-1 thousand IU/day.

Contraindications

Hypersensitivity to the components of the drug (including lactose intolerance, lactase deficiency, glucose-galactose malabsorption), hypercalcemia, hypercalciuria, calcium nephrourolithiasis, hypervitaminosis D, decalcifying tumors (myeloma, bone metastases, sarcoidosis), osteoporosis due to immobilization, phenylketonuria (contains aspartame), pulmonary tuberculosis (active form), chronic renal failure, children under 3 years of age.

Use with caution: pregnancy, lactation period.

Side effects

Dyspeptic disorders of the gastrointestinal tract (constipation, flatulence, nausea, stomach pain, diarrhea).
Allergic reactions.
Hypercalcemia and hypercalciuria (increased calcium content in the blood and urine).

Overdose

In case of signs of overdose, consult a physician.

Symptoms: thirst, polyuria, decreased appetite, nausea, vomiting, constipation, dizziness, weakness, headache, fainting, coma; with long-term use: vascular and tissue calcinosis.

Treatment: administration of large amounts of fluid, use of “loop” diuretics (e.g., furosemide), glucocorticosteroids, calcitonin, bisphosphonates.

In the case of development of clinical symptoms of overdose, blood calcium and creatinine concentrations should be determined. In case of elevated serum calcium or creatinine concentration the drug dose should be reduced or the treatment should be temporarily stopped.

Pregnancy use

The daily dose should not exceed 1500 mg of calcium and 600 ME of vitamin D₃. Hypercalcemia that develops as a result of overdose during pregnancy can cause defects in mental and physical development of the child. Vitamin D and its metabolites can penetrate into breast milk, so it is necessary to consider intake of calcium and vitamin D from other sources in mother and child.

Similarities

Complivit Calcium D3 Forte, Calcium D3 Nicomed, Calcium D3 Nicomed Forte, Natecal D3, Complivit Calcium D3, Univit Kids, Vitamin D3