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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 2020-03-15
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Diseases caused by impaired calcium and phosphorus metabolism due to insufficient endogenous production of 1,25-dihydroxyvitamin D3: renal osteodystrophy, osteoporosis, postoperative or idiopathic hypoparathyroidism, pseudohypoparathyroidism, hyperparathyroidism with bone damage, vitamin D-resistant rickets or osteomalacia, vitamin D-dependent rickets, hypocalcemia or neonatal rickets, calcium malabsorption, rickets associated with malabsorption and malnutrition, osteomalacia.
Rickets (with impaired absorption of vitamin D), osteomalacia, osteoporosis, pathological changes in the bones (hypofunction of the parathyroid glands, chronic kidney failure).
Inside, in/out, once a day.
The ampoules must be shaken several times before use, and the drops should not be diluted. Start treatment with minimal doses, monitoring once a week the level of calcium and phosphorus in the blood plasma. The dose of the drug can be increased by 0.25 or 0.5 mcg/day until the biochemical parameters are stabilized. When the minimum effective dose is reached, it is recommended to monitor the level of calcium in the blood plasma every 3-5 weeks. The duration of the course is determined by the doctor individually in each specific case and depends on the nature of the disease and the effectiveness of therapy. In some cases, the drug is used for life
Adults with osteomalacia are prescribed orally at a dose of 1-3 mcg/day.
In hypoparathyroidism — 2-4 mcg/day.
In osteodystrophy in chronic renal failure-up to 2 mcg/day.
In postmenopausal, senile, steroid and other types of osteoporosis-0.5-1 mcg/day.
The drug can be administered intravenously after hemodialysis. The injection should be carried out in the return line of the device (as close as possible to the patient - to eliminate the risk of absorption of alfacalcidol by plastic) at the end of each dialysis. The initial dose is 1, the maximum is 6 mcg per dialysis, but no more than 12 mcg during the week. The solution does not require additional dilution.
For young children, it is recommended to prescribe the drug in the dosage form of a drop (dosing and taking capsules are difficult).
With a body weight of less than 20 kg–0.01-0.05 mcg/kg/day, with a weight of 20 kg and above-1 mcg/day (except in cases of renal osteodystrophy).
In renal osteodystrophy in children, the dose is 0.04-0.08 mcg/kg / day. The dose is determined in accordance with the dynamics of biochemical parameters in order to prevent hypercalcemia.
Inside. Adults with osteoporosis associated with chronic renal failure — 0.5-1 mcg (up to 4 mcg/day) 1 time a day.
With hypofunction of the parathyroid glands, diseases associated with impaired vitamin D metabolism-1-4 mcg 1 time a day.
Hypersensitivity to the components of the drug, hypercalcemia, hyperphosphatemia (except for those with hypoparathyroidism), hypermagnesemia, vitamin D intoxication.
The solution for intravenous administration should not be used in patients with hypersensitivity to injectable solutions containing propylene glycol.
From the side of metabolism: rarely-hypercalcemia, very rarely-a slight increase in HDL in plasma. In patients with severe impairment of renal function may develop hyperphosphatemia.
From the digestive tract and liver: nausea, dry mouth, feeling of discomfort in the epigastrium, constipation, rarely-a slight increase in ALT, AST in plasma.
From the central nervous system: rarely-weakness, fatigue, dizziness, drowsiness.
From the cardiovascular system: rarely-tachycardia.
Allergic reactions: rarely-skin rash, itching.
Nausea, vomiting, dyspepsia, diarrhea, dizziness, tinnitus, increased blood pressure, tachycardia, conjunctival hyperemia.
Symptoms: weakness, lethargy, dizziness, headache, nausea, dry mouth, constipation, diarrhea, heartburn, vomiting, pain in the epigastrium, abdomen, bones, itching, palpitations.
Treatment: stop taking the drug. In the early stages of acute overdose, gastric lavage and/or the appointment of mineral oil is indicated (which helps to reduce the absorption and increase the excretion of the drug in the feces). In severe cases-intravenous administration of isotonic sodium chloride solution, the appointment of loop diuretics, glucocorticosteroids.
Increases the absorption of calcium and phosphorus in the intestine, increases their reabsorption in the kidneys, increases bone mineralization, and reduces the content of parathyroid hormone in the blood. The main advantages of alfacalcidol compared to vitamin D are the rapid action and the possibility of more precise dose adjustment, which reduces the risk of long-term hypercalcemia.
Fat-soluble, bioavailability when taken orally is 100%. After absorption, it is rapidly converted to 1,25-dihydroxyvitamin D3, mainly in the liver. The level of 1,25-dihydroxyvitamin D3 in the blood plasma, it reaches a maximum in 8-12 hours after taking a single dose of alfacalcidol, T1/2 1,25-Dihydroxyvitamin D3 - about 35 hours.
- Correctors of bone and cartilage metabolism
- Vitamins and vitamin-like products
When used concomitantly with digitalis preparations, the risk of heart rhythm disorders increases, with antacids-the risk of hypermagnesemia, with calcium preparations and thiazide diuretics — the risk of hypercalcemia.
Combined use with barbiturates, anticonvulsants and other drugs that activate microsomal oxidation enzymes in the liver requires the use of a higher dose of alfacalcidol.
Mineral oil (when used together for a long time), colestyramine, colestipol, sucralfate, antacids, albumin preparations reduce the absorption of alfacalcidol.
However, we will provide data for each active ingredient