Alpha D3-Teva – regulates calcium-phosphorus metabolism.
Alfacalcidol (1α-hydroxyvitamin D3) is rapidly converted in the liver to 1,25-dihydroxyvitamin D3, the active metabolite of vitamin D (calcitriol), which acts as a regulator of calcium and phosphorus metabolism. 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 and 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 production deficit D-hormone (calcitriol), a reduction in total muscle mass (sarcopenia) and the appearance of muscular weakness syndrome (due to the disruption of the normal functioning of the neuromuscular system), which is accompanied by an increased risk of falls and resulting injuries and fractures. Several studies have shown a significant reduction in the incidence of falls of elderly patients in the application of alfacalcidol. Alfacalcidol stimulates the regeneration of muscle fibers that restores lost muscle tone.
absorption. After oral alfacalcidol is rapidly absorbed from the gastrointestinal tract. Cmax plasma levels achieved after 8-12 hours after a single dose of alfacalcidol.
Metabolism. 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).
Teva Pharmaceutical Enterprise Co., Ltd., Israel
Children older than 3 years, for adults prescribed by a doctor, children on prescription
1 capsule contains:
alfacalcidol – 0,5 mcg.
anhydrous citric acid – 0.015 mg
Propyl Gallate – 0.02 mg
α-tocopherol (vit E.) – 0.02 mg
ethanol – 1.145 mg,
Peanut oil – up to 100 mg.
The composition of a soft gelatin capsule:
gelatin – 48.35 mg,
glycerol – 11.81 mg
anidrisorb 85/70 – 7.89 mg (Sorbitol – 24-40% sorbitan – 20-30% Mannitol – 0-6% higher polyols – 12.5-19% Water – 15-17%),
iron oxide red dye (E172) – 0.043 mg,
titanium dioxide (E171) – 0.65 mg.
The composition of black ink:
Shellac – 54%
dye black iron oxide (E172) – 46%.
Bone fractures, osteoporosis, rickets, malnutrition
- The renal acidosis.
- Bone Disease in patients with chronic renal failure.
- Osteoporosis, including postmenopausal, senile, steroid.
- Rickets and osteomalacia associated with malnutrition or suction.
- Hypoparathyroidism and pseudohypoparathyreosis.
- hypophosphatemic vitamin-D-resistant rickets and osteomalacia.
- Psevdodefitsitny (vitamin-D-dependent) rickets and osteomalacia.
- Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and hypophyseal syndrome).
- hyperphosphatemia (except hyperphosphatemia with hyperparathyroidism);
- hypervitaminosis D;
- lactation (breastfeeding);
- Children under 3 years;
- increased sensitivity to alfacalcidol and other ingredients.
Precautions should be prescribed the drug for nephrolithiasis, atherosclerosis, congestive heart failure, chronic renal failure, sarcoidosis or other granulomatosis, pulmonary tuberculosis (active form) in patients with an increased risk of hypercalcaemia, especially in the presence of urolithiasis, children over the age of 3 years.
From the nervous system: general weakness, fatigue, headache, dizziness, drowsiness.
Allergic reactions: skin rash, itching.
From the musculoskeletal system: mild pain in the muscles, bones and joints.
Laboratory findings: hypercalcemia, a slight increase in the concentration of HDL; may develop hyperphosphatemia (in patients with severe renal impairment).
From the CCC: tachycardia, increased blood pressure.
From the digestive system: anorexia, vomiting, heartburn, abdominal pain, nausea, dryness of the oral mucosa, discomfort in epigastrium, constipation, diarrhea, minor elevation of liver enzymes.
How to accept, acceptance rate and dosage
Inside, regardless of the meal, without chewing, with enough liquid, once per day .. The recommended daily dose -Teva Alpha D 3 can be taken directly in one step, a dose can be divided 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 D3 -Teva (Alpha D3 -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.
At temperatures above 25 ° C
In the treatment of osteoporosis alfacalcidol can be administered in combination with estrogen and drugs which reduce bone resorption.
With simultaneous use of alfacalcidol with digitalis drugs increases the risk of arrhythmia.
Inductors microsomal liver enzymes (.. In t h phenytoin and phenobarbital) decrease and inhibitors – alfacalcidol increase the concentration in plasma (possibly change its effectiveness).
Suction alfacalcidol reduced by combining it with mineral oil (for a long time), colestyramine, colestipol, sucralfate, antacids, medications based on albumin.
Antacids increases the risk of hypermagnesemia and giperalyuminiemiya.
Toxic effects of impaired retinol, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin.
Calcitonin, derivatives etidronovoy and pamidronic acid, plicamycin, gallium nitrate and glucocorticosteroids reduce the effect.
Alfacalcidol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphataemia.
Simultaneous use of calcium preparations with alfacalcidol, thiazide diuretics may cause hypercalcemia by raising the calcium absorption in the intestine, increasing its reabsorption in the kidney.
The therapy should not be prescribed alfacalcidol other drugs of vitamin D and its derivatives because of possible additive interaction and increase the risk of hypercalcemia.
Therapy should be under constant control of the concentration of calcium and phosphate in the blood (at the beginning of the treatment – 1 times a week, and when reaching for the entire period of treatment – the concentration of calcium in plasma and urine every 3-5 weeks), as well as the activity of alkaline phosphatase ( AP) (in chronic renal failure – a weekly monitoring). When CRF is required prior correction of hyperphosphataemia.
When the normalization of alkaline phosphatase in the blood plasma, it is necessary to reduce the dose of the drug Alpha D3 -Teva, thus avoiding the development of hypercalcemia. Hypercalcemia or hypercalciuria are corrected to remove the drug and decrease calcium intake to normalize the calcium concentration in the blood plasma. Typically, this period is 1 week. After normalization therapy continues, assigning the latter half of the applied dose. It will be appreciated that the sensitivity to vitamin D for different individual patients, and some patients receiving therapeutic doses may even cause hypervitaminosis phenomena.
In children receiving vitamin D for a long time, and increased risk of growth retardation. For preventing hypovitaminosis D most preferably balanced nutrition.
In old age, the need for vitamin D may increase due to reduced absorption of vitamin D, reducing the skin’s ability to synthesize pro-vitamin D 3, reducing the time insolation increase the incidence of renal failure.
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.