Alfacalcidol + Calcium carbonate (Alphacalcidolum + Calcii carbonas)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Vitamins and vitamin-like remedies

Included in the formulation
  • Alfadol-Ca
    capsules inwards 
    Panacea Biotech Co., Ltd.     India
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    ONLS

    АТХ:

    A.11.C.C   Vitamin D and its derivatives

    Pharmacodynamics:

    Combined drug regulating the exchange of calcium and phosphorus. Replenishes deficiency of calcium and vitamin D3 in organism. The main therapeutic effects of alfacalcidol are an increase in the concentration of 1,25-hydroxycolecalciferol in the blood and, as a consequence, an increase in the absorption of calcium and phosphate; improvement of mineralization and reduction of bone resorption, normalization of parathyroid hormone in the plasma, reduction of bone and muscle pain.

    Calcium is involved in the formation of bone tissue, the process of blood clotting, the transmission of nerve impulses, the contractions of skeletal muscles, the regulation of the heart.

    The rationale for the combination of alfacalcidol and calcium

    Alfacalcidol enhances the absorption of calcium from the gastrointestinal tract and causes a therapeutic effect in osteoporosis. The content of elemental calcium in calcium carbonate is 40%, that is, 500 mg calcium carbonate contains 200 mg of elemental calcium, which corresponds to the minimum physiological needs.

    Pharmacokinetics:

    Absorption is high. TCmax - 8-18 hours. In the blood it binds to specific alpha globulins. Rapidly transformed in the liver with the formation of an active metabolite of calcitriol (1,25-dihydroxycolecalciferol), a smaller part is metabolized in bone tissue. Unlike natural vitamin D, it is not metabolized in the kidneys, which allows it to be prescribed for vitamin D deficiency in patients with renal insufficiency (the effect does not depend on the hydroxylation in the kidneys).

    It is excreted by the kidneys and with bile in approximately the same amount.

    Indications:

    Osteoporosis (menopausal, senile, steroid, idiopathic and others) and its complications (fractures of bones); renal osteodystrophy; Hypoparathyroidism and hyperparathyroidism (with bone damage); chronic renal failure.

    ICD-10

    IV.E50-E64.E58   Alimentary calcium deficiency

    IV.E50-E64.E55   Insufficiency of vitamin D

    XIII.M80-M85.M82 *   Osteoporosis in diseases classified elsewhere

    XIII.M80-M85.M81.8   Other osteoporosis

    XIII.M80-M85.M81.5   Idiopathic osteoporosis

    XIII.M80-M85.M81.4   Medicinal osteoporosis

    XIII.M80-M85.M81.1   Osteoporosis after removal of ovaries

    XIII.M80-M85.M81.0   Postmenopausal osteoporosis

    XIII.M80-M85.M81   Osteoporosis without pathological fracture

    XIII.M80-M85.M80   Osteoporosis with pathological fracture

    Contraindications:Hypersensitivityurolithiasis (formation of calcium stones), increased calcium content in the blood (in persons with strengthened parathyroid function, hypervitaminosis D, osteochondrosis, metastases of tumors in the bone); Hyperphosphatemia (except when the latter develops against a background of hypoparathyroidismzma); hypermagnesia; Zollinger's syndrome; intolerance to peanuts or soybeans; children'sthe age of 18 years.
    Carefully:Chronic kidney failure, pregnancy, lactation.
    Carefully to accept persons suffering from renal insufficiency, as well as to patients on hemodialysis. In the case of long-term treatment, it is necessary to check the amount of calcium secreted by the kidneys.
    Pregnancy and lactation:The application is possible if the expected benefit for the mother exceeds the potential risk to the fetus. Calcium: The FDA category is not defined. Studies in humans and animals have not been conducted. Problems with the administration of therapeutic doses are not recorded. Reception may be necessary.
    Dosing and Administration:Inside. Adults - 1-2 capsules per day.
    Side effects:Hypercalcemia, hyperphosphataemia in patients with marked renal impairment, constipation, diarrhea, nephrocalcinosis, allergic reactions (pruritus, rash, urticaria).
    Overdose:

    Early symptoms. Bone pain, constipation, diarrhea, drowsiness, dry mouth, thirst, enuresis, irregular heartbeats, loss of appetite, metallic taste in the mouth, muscle pain, nausea, vomiting, itching, fatigue.

    Late symptoms. Darkening of urine, conjunctivitis, decreased libido, calcification, fever, high blood pressure, eye sensitivity to light, eye irritation, lethargy, psychosis, rhinorrhea, weight loss.

    Treatment: should cancel the drug. Severe form of hypercalcemia requires supportive treatment measures - hydration with the introduction of infusion saline solutions, in some cases - the appointment of "loop" diuretics, corticosteroids.

    In case of acute overdosage, preliminary treatment with gastric lavage and / or administration of mineral oil is necessary, which helps to reduce absorption and increase the excretion of the drug through the intestine.

    Interaction:

    The acidic pH of food products increases, slightly alkaline decreases the absorption of Ca2 +.

    Thiazide diuretics: decreased elimination of Ca2 + and increased blood concentrations.

    Kolestiramin: with simultaneous intake of impaired absorption.

    Kolekaltsiferol: with the simultaneous use of additive effect, the development of hypercalcemia.

    Sucralfate: impaired absorption of alfacalcidol.

    Tetracycline: Calcium carbonate enhances the absorption of tetracycline

    Ciprofloxacin: calcium carbonate interferes with the absorption of ciprofloxacin.

    Iron preparations: calcium carbonate enhances the absorption of iron.

    Fluoride preparations: calcium carbonate enhances the absorption of fluoride-containing drugs.

    Drugs digitalis: increased arrhythmias, joint use avoided.

    Barbiturates, anticonvulsants, which are inducers of microsomal liver enzymes: a dose adjustment is necessary to achieve the therapeutic effect of alfacalcidol.

    Special instructions:

    Alfacalcidol is an active derivative of vitamin D3. During treatment, do not prescribe therapeutic doses of vitamin D3 and its derivatives due to the possibility of additive effects and an increased risk of hypercalcemia.

    The drug enhances the intestinal absorption of calcium and phosphate, the concentration of which must be controlled, especially in patients with renal insufficiency. It is necessary to monitor the concentrations of calcium, phosphate, alkaline phosphatase, magnesium and creatinine.

    If hypercalcemia or hypercalciuria occur, they can be quickly eliminated by lifting the drug to normalize the calcium concentration in the plasma. The drug should be used with caution in patients with hypercalciuria, in particular in patients with urolithiasis.

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