FarmGruppa: vitamin – calcium-phosphorus metabolism regulator.
Pharmacological action: Alpha D3-Teva – vitamin, calcium and phosphorus metabolism regulator. It is a precursor of the active metabolite of vitamin D3 – calcitriol. Increases the absorption of calcium and phosphorus in the intestine, increases their reabsorption in the kidneys, restores a positive calcium balance in the treatment of calcium malabsorption syndrome, reduces blood levels of parathyroid hormone.
Acting on both sides of the process of bone remodeling (bone resorption and synthesis), alfacalcidol not only increases bone mineralization, but also improves its elasticity by stimulating the synthesis of bone matrix proteins, bone morphogenetic proteins, bone growth factors, that can reduce the frequency of fractures.
Elderly patients on the background of endocrine and immune dysfunction, including deficits of products D-hormone (calcitriol), a reduction in total muscle mass (sarcopenia) and the appearance of muscle weakness syndrome (due to the disruption of the normal functioning of the neuromuscular system), which is accompanied by an increase in risk of falls and resulting injuries and fractures. Several studies have shown a significant reduction in the incidence of falls of elderly patients using Alfacalcidol.
After oral alfacalcidol is rapidly absorbed from the gastrointestinal tract. Cmax plasma levels achieved after 8-12 hours after a single dose of alfacalcidol.
Conversion alfacalcidol, calcitriol (1.25 digidroksikolekaltsiferol) occurs in the liver through hydroxylation at carbon atom 25, wherein the hydroxylation process occurs very rapidly (has a substrate-dependent manner). Unlike native vitamin D alfacalcidol needs no hydroxylation in the kidneys is therefore effective even in patients with reduced activity of renal 1 alpha-hydroxylase activity (renal failure, advanced age).
T1 / 2 is 35 hours. Excreted by the kidneys and in the intestine in bile in approximately equal proportions.
Teva Pharmaceutical Enterprise Co., Ltd., Israel
Children prescribed by a doctor for adults on prescription
alfacalcidol – 0.25 mcg.
Excipients: anhydrous citric acid – 0.015 mg of propyl gallate – 0.02 mg, D, L-α-tocopherol (vit E.) – 0.02 mg, absolute ethanol – 1.145 mg, peanut oil – up to 100 mg.
The composition of a soft gelatin capsule: gelatin – 48.55 mg Glycerol 85% – 11.7 mg, anidrisorb 85/70 – 7.92 mg (Sorbitol – 24-40% sorbitan – 20-30% Mannitol – 0-6% higher polyols – 12.5 -19% water – 15-17%), iron oxide red (E172) – 0.54 mg.
Composition of black ink food A10379: shellac – 54%, iron oxide black (E172) – 46%
Osteoporosis, bone fractures, rickets
- Osteoporosis, including postmenopausal, senile, steroid.
- Osteodystrophy in patients with chronic renal failure.
- Hypoparathyroidism and pseudohypoparathyreosis.
- Rickets and osteomalacia associated with malnutrition or suction.
- Hypophosphatemic vitamin-D-resistant rickets and osteomalacia.
- Psevdodefitsitny (vitamin-D-dependent) rickets and osteomalacia.
- Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, rickets and late adiposogenital dystrophy).
- Renal acidosis.
- Increased sensitivity to alfacalcidol and other ingredients.
- Hyperphosphatemia (except hyperphosphatemia with hypoparathyroidism).
- Hypervitaminosis D.
- Pregnancy (I term).
- The period of breastfeeding.
- Children under the age of 3 years.
Be wary of:
- Chronic heart failure.
- Chronic renal failure.
- sarcoidosis or other granulomatous.
- pulmonary tuberculosis (active form).
- Pregnancy (II-III trimester).
- In patients with increased risk of hypercalcaemia, especially in the presence of kidney stones.
- Children older than 3 years.
- Anorexia, nausea, vomiting, heartburn, abdominal pain, dry mouth, discomfort in epigastrium, constipation, diarrhea.
Rarely – slight increase in “liver” enzymes.
- From the nervous systemGeneral weakness, fatigue, headache, dizziness, drowsiness.
- From the side of cardiovascular systemTachycardia.
- Allergic reactionsSkin rash, itching.
- On the part of the musculoskeletal systemModerate pain in the muscles, bones and joints.
- Laboratory findingsHypercalcemia, a slight increase in high density lipoprotein. In patients with severe renal impairment may develop hyperphosphatemia.
How to accept, acceptance rate and dosage
Inside. The recommended daily dose Alpha D 3 -Teva can be taken once at a time, can be divided dose into 2 doses. Therapy can last from 2-3 months to 1 year or more.
Duration of treatment is determined by the doctor for each patient individually.
- In osteomalacia associated with malnutrition or suctionFrom 1 to 3 mg / day for at least 2-3 months.
- In hypoparathyroidismFrom 2 to 4 mg / day.
- In osteodystrophy in chronic renal failureFrom 1 to 2 mg / day courses for 2-3 months, 2-3 times a year.
- In the Fanconi syndrome and renal acidosisFrom 2 to 6 g / day.
- In hypophosphatemic osteomalaciaTherapy is started with a dose of 4 mg / day. The maximum daily dose may reach 20 mcg.
At high doses need to consider moving to a higher dosage capsules Alpha D 3 -Teva (Alpha D 3 -Teva caps. 1 g pack. 30 Teva Pharmaceutical Enterprise Co., Ltd. .), or other dosage forms alfacalcidol.
- In osteoporosis, in Vol. H. Postmenopausal, senile, steroidFrom 0.5 to 1 g / day. Recommended to begin treatment with the minimum of said doses, controlling every 1 nedelyuuroven kaltsiyaifosforav plasma. Dose can be increased to 0.5 micrograms / day to stabilize the biochemical parameters.
Children older than 3 years
- In rickets and osteomalacia associated with malnutrition or suctionFrom 1 to 3 mg / day for at least 2-3 months.
- In osteodystrophy in chronic renal failureFrom 0.5 to 1 g / day courses for 2-3 months 2-3 times per year.
- In the Fanconi syndrome and renal acidosisFrom 2 to 6 g / day.
In hypophosphatemic rickets and osteomalacia
Therapy is started with a dose of 1 .mu.g / day.
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children.
In the treatment of osteoporosis can be administered in combination with estrogen and antiresorptive drugs of different groups.
With simultaneous use of Alpha D 3 -Teva with digitalis drugs increases the risk of cardiac arrhythmias.
When concomitant administration with barbiturates, anticonvulsants and other drugs activating microsomal oxidation enzymes in the liver, it is necessary to apply a higher dose of alpha D 3 -Teva.
Suction alfacalcidol reduced by combining it with mineral oil (for a long time), colestyramine, colestipol, sucralfate, antacids, medications based on albumin.
In the application in conjunction with Alpha D 3 -Teva antacids or laksativodializa increased risk of hypermagnesemia.
The simultaneous appointment of calcium drugs, thiazide diuretics increases the risk of hypercalcemia.
The therapy Alpha D 3 -Teva should not be prescribed vitamin D and its derivatives because of possible additive interaction and increase the risk of hypercalcemia.
Precautions drug prescribed to patients with a tendency to hypercalcemia. During the period of the drug should be regularly to determine the level of calcium in the blood plasma.
In the presence of the biochemical signs of normalization of the bone structure (normalization of alkaline phosphatase in the blood plasma) must be a corresponding reduction in the dose Alpha D 3 -Teva, thus avoiding the development of hypercalcemia.
Hypercalcemia or hypercalciuria can be adjusted by drug withdrawal and reduce calcium intake until until normal calcium concentration in blood plasma. Usually this period is 1 week. Then the therapy can be continued, since the latter half of the applied dose.
Pregnancy and lactation
During pregnancy (II-III trimester) alfacalcidol prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus. In animal experiments, it is shown that calcitriol in doses 4-15 times higher than the recommended doses for humans, has a teratogenic effect.
Hypercalcemia in the mother during pregnancy, associated with long-term vitamin D overdose can cause fetus increased sensitivity to vitamin D, suppression of parathyroid function, specific elfopodobnoy appearance syndrome, mental retardation, aortic stenosis.
The drug is contraindicated during breast-feeding.