Postmenopausal osteoporosis and senile with simultaneous deficiency of vitamin D or its active metabolites. Hypocalcaemia, especially in patients with disorders that lead to impaired hydroxylation of vitamin D in the kidneys. Rickets and osteomalacia resistant to vitamin D. Parathyroidism. Calcium metabolism disorders in patients with chronic renal failure. Nephrotic syndromes in children after long-term treatment with glucocorticosteroids. Renal osteostrophy.
Composition:
One capsule contains 0.25 μg or 1.0 μg alfacalcydol.
Action:
Vitamin D analogue (1-a-hydroxycholecalciferol). Alfacalcidol is a derivative of cholecalciferol hydroxylated at position 1, which bypasses the hydroxylation step occurring in the kidneys (important in people with impaired renal function, when hydroxylation in kidney tissue is impossible or difficult). For its activation, only hydroxylation in the liver is necessary for calcitriol. The calcitriol formed as a result of activation, along with parathyroid hormone and calcitonin, is the basic factor regulating the calcium metabolism in the body. Providing adequate calcium supply, it leads to an intensification of the process of calcium incorporation into the bone structure. Calcitriol triggers processes that increase the level of calcium in the blood by increasing the synthesis of protein transporting calcium from the gastrointestinal tract into the blood and increasing the resorption of calcium in the kidney tubules. Alfacalcidol is absorbed from the gastrointestinal tract at approximately 100%, with approximately 50% of the dose converted to calcitriol. The elimination half-life of calcitriol from the body, corresponding to the period of half-life of biological activity, is estimated at approximately 36 hours. Elimination is released in patients undergoing dialysis. Both alfacalcidol and calcitriol are metabolized in the liver to inactive compounds and excreted in about 13% in the urine and in the remaining amount in the faeces.
Contraindications:
Hypersensitivity to alfacalcidol, other ingredients of the preparation, peanuts or soya (the product contains peanut oil). Hypercalcemia, hyperphosphatemia (with the exception of hypothyroidism), hypermagnesaemia, spontaneous hypercalciuria. Osteomalacia following aluminum poisoning. Overdose and vitamin D poisoning. Calcium renal stones. Severe liver damage.
Precautions:
Caution in elderly patients (dose reduction may be indicated). Caution use in patients with impaired renal function, tertiary hyperparathyroidism, or regularly hemodialyzed due to the risk of hypercalcaemia (in this case, the drug should be discontinued for about 1 week and then possibly resumed at a reduced dose). Caution should be exercised in patients treated with cardiac glycosides (hypercalcemia may lead to cardiac dysfunction). If you are on a low calcium diet, the response to alfacalcidol may be reduced or not at all. In patients with high levels of calcium in the blood in the course of renal osteodystrophy, there may be autonomic hyperparathyroidism and there may be no response to alphacalcidol. Due to the auxiliary substances of the drug cautiously used in people with asthma.
Pregnancy and lactation:
Do not use during pregnancy unless clearly necessary. Do not use during breast-feeding.
Side effects:
It was observed with an unknown frequency: hypersensitivity reactions (eg hypersensitivity in patients with asthma, skin irritation, contact dermatitis, conjunctival irritation), headache or dizziness, confusion (as a result of hypercalcaemia); hypercalcemia, hyperphosphatemia (especially in patients with renal insufficiency), arrhythmia (associated with hypercalcaemia), diarrhea, constipation, nausea, vomiting, dry mouth, increased thirst, irritation of mucous membranes, including gastric mucosa, metallic taste in the mouth (as a result of hypercalcaemia), pruritus, rash, urticaria, muscle pain, bone pain (associated with hypercalcemia), hypercalciuria, polyuria, nephrocalcinosis, ectopic calcosis and renal dysfunction, and fatigue (associated with hypercalcemia).
Dosage:
Individual dosage is recommended, taking into account calcium parameters and daily calcium supply. As the criteria for a well-chosen dose, the concentration of calcium in the blood is within the normal range and the dose does not exceed 350 mg (with daily diuresis up to 2000 ml). The calcium creatinine index should not exceed 1.0 and should not increase more than 3 times from the start of treatment. Orally. Post-menopausal osteoporosis in adults about above 40 kg: 0.5-1 μg once a day. Nephrotic syndromes in children after long-term corticotherapy: children at birth. 20-40 kg - 0.25-0.5 μg once a day; children about the month of less than 20 kg - 0.25 μg once a day. Hypocalcaemia, rickets and osteomalacia resistant to vitamin D, hypoparathyroidism, calcium imbalance in patients with chronic renal failure, renal osteodystrophy: adults. over 40 kg - 0.5-1 μg once a day; children about the month of 20-40 kg - 0.25-0.5 μg once a day; children about the month of less than 20 kg - 0.25 μg once a day.
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