Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
Regulator of calcium and phosphorus metabolism, 1? -hydroxyvitamin D 3 . It causes an increase in the absorption of calcium and phosphorus in the intestine, an increase in their reabsorption in the kidneys; regulates the mineralization of bone tissue. Restores a positive calcium balance in the treatment of calcium malabsorption syndrome and reduces the concentration of parathyroid hormone in the blood.
Affecting both parts of the bone remodeling process (resorption and synthesis), alfacalcidol not only increases the mineralization of bone tissue, but also increases its elasticity by stimulating the synthesis of bone matrix proteins, bone morphogenetic proteins, bone growth factors, which helps to reduce the incidence of fractures.
In elderly patients on the background of endocrine-immune dysfunction, incl. (calcitriol), a decrease in the total muscle mass (sarcopenia) and the appearance of a syndrome of muscle weakness (due to disruption of the normal functioning of the neuromuscular system), which is accompanied by an increased risk of falls and the resulting injuries and fractures. A number of studies have shown a significant reduction in the incidence of falls in elderly patients with the use of alfacalcidol.
Alfacalcidol stimulates the regeneration of muscle fibers, which restores the lost muscle tone.
PHARMACOKINETICS
After oral administration, alfacalcidol is rapidly absorbed from the digestive tract. T max of the active substance in blood plasma is from 8 to 18 hours.
Alfacalcidol is metabolized in the liver to form the main active metabolite of calcitriol (1, 25-dihydroxyvitamin D 3 ). A smaller part of the active substance is metabolized in bone tissue.
INDICATIONS
Osteodystrophy (including chronic renal failure), hypoparathyroidism and pseudohypoparathyreasis, rickets and osteomalacia of various genesis, osteoporosis (including postmenopausal, senile, steroid), renal acidosis, Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and adiposogenital dystrophy).
DOSING MODE
Individual. The daily dose for adults varies from 0.07 Ојg to 20 Ојg, for children over the age of 3 years - 0.01-0.08 Ојg / kg.
SIDE EFFECT
On the part of the digestive system: anorexia, nausea, vomiting, dry mouth, discomfort in the epigastric region, constipation; rarely - a slight increase in ALT activity, AST.
From the side of the central nervous system: weakness, fatigue, dizziness, drowsiness.
From the cardiovascular system: tachycardia.
Allergic reactions: skin rash, itching.
From the side of metabolism: rarely - increased HDL in plasma; with severe renal dysfunction, hyperphosphataemia.
CONTRAINDICATIONS
Hypercalcemia, hyperphosphatemia (except for hyperphosphatemia in hyperparathyroidism), hypermagnesia, hypervitaminosis D, lactation (breastfeeding), children under 3 years of age, hypersensitivity to alfacalcidol.
PREGNANCY AND LACTATION
Application in pregnancy is possible only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.
Application during lactation (breastfeeding) is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution apply in patients with an increased risk of hypercalcemia, especially with urolithiasis.
APPLICATION FOR CHILDREN
The daily dose for children is 0.01-0.08 Ојg / kg.
SPECIAL INSTRUCTIONS
With caution should be used in patients with nephrolithiasis, atherosclerosis, chronic heart failure, chronic renal failure, in sarcoidosis or other granulomatosis, pulmonary tuberculosis (active form), in patients with an increased risk of hypercalcemia, especially in the presence of urolithiasis, in children aged over 3 years old
During the treatment should regularly monitor the level of calcium in blood and urine, monitor the development of the therapeutic effect and, if necessary, adjust the dose of alfacalcidol in order to avoid the development of hypercalcemia and hypercalciuria.
Unlike natural vitamin D, alfacalcidol is not metabolized in the kidneys. There are reports of the effectiveness of alfacalcidol in secondary hyperparathyroidism due to renal insufficiency.
DRUG INTERACTION
With the simultaneous use of drugs that induce the induction of microsomal liver enzymes, the therapeutic effect of alfacalcidol decreases (a higher dose of alfacalcidol should be used).
With the simultaneous use of alfacalcidol with digitalis drugs, the risk of arrhythmia increases; with calcium preparations, thiazide diuretics - increases the risk of hypercalcemia; with antacids or laxatives - increases the risk of hypermagnesemia.
Antiepileptic drugs, phenytoin, barbiturates, reduce the effectiveness of alfacalcidol; mineral oils, colestyramine, colestipol, sucralfate, antacids, albumin reduce its absorption. Simultaneous laxativodialysis increases the risk of hypermagnesemia and hyperaluminemia.
Do not use simultaneously with colcalciferol (vitamin D) and its derivatives.
