ALPHA A3-TEVA

Active material: Alfacalcidol
When ATH: A11CC03
CCF: Preparation, regulates the exchange of calcium and phosphorus
ICD-10 codes (testimony): E20, E20.1, E21, E55.0, (E) 72.0, E83.3, M81.0, M81.1, M81.2, M81.4, M81.8, M82, M83, N25.0, N25.8
When CSF: 16.04.01.01
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

Pharmaceutical form, composition and packaging

Capsules soft gelatin, russet, Oval, printed with black ink dosage “0.25”; contents of capsules – oil solution of pale yellow color.

Excipients: Citric acid anhydrous, propyl gallate, D,L-a-токоферол (wreathed. IS), ethanol (absolute), peanut butter.

The composition of a soft gelatin capsule: gelatin, glycerol 85%, anidrisorʙ 85/70 (sorbitol, sorbitan, mannitol, higher polyols, water), iron oxide red (E172).
The composition of the ink black food A10379: shellac, iron oxide black (E172).

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
30 PC. – vials made of polypropylene (1) – packs cardboard.
60 PC. – vials made of polypropylene (1) – packs cardboard.

Capsules soft gelatin, from cream to ivory, printed with black ink dosage “1.0”; contents of capsules – oil solution of pale yellow color.

Excipients: Citric acid anhydrous, propyl gallate, D,L-a-токоферол (wreathed. IS), ethanol (absolute), peanut butter.

The composition of a soft gelatin capsule: gelatin, glycerol 85%, anidrisorʙ 85/70 (sorbitol, sorbitan, mannitol, higher polyols, water), iron oxide yellow (E172), Titanium dioxide (E171).
The composition of the ink black food A10379: shellac, iron oxide black (E172).

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
10 PC. – vials made of polypropylene (1) – packs cardboard.
30 PC. – vials made of polypropylene (1) – packs cardboard.

Pharmacological action

vitamin – regulator of calcium-phosphorus metabolism. It is a precursor of the active metabolite of vitamin D₃. Increases calcium and phosphorous absorption in the intestine, increases their reabsorbqiyu in the kidneys, increases bone mineralization, lowers blood parathyroid hormone.

Alpha D₃^®-Teva restores a positive calcium balance in the treatment of calcium malabsorption, thereby, reducing the intensity of bone resorption, which helps to reduce the incidence of fractures.

Elderly patients on the background of endocrine and immune dysfunction, incl. deficit production D-hormone (pharmacologically active metabolite of vitamin D), overall there is a decrease in 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 increased risk of falls and resulting injuries and fractures. In some isssledovany it has shown a significant reduction in the incidence of falls of elderly patients using alfacalcidol.

Pharmacokinetics

Absorption

After oral alfacalcidol is rapidly absorbed from the gastrointestinal tract. T_max the drug in the plasma is from 8 to 12 no.

Metabolism

The liver is metabolized in alfacalcidol main active metabolite of vitamin D₃ – calcitriol (1and, 25-digidroksivitamin D₃). A smaller part of the drug is metabolized in the bone. Unlike natural vitamin D₃ biotransformation of the drug does not occur in the kidneys, it can be used in patients with renal disease patients.

Testimony

- Osteoporosis (incl. postmenopauzny, senile, steroidal);

- osteodystrophy in patients with chronic renal failure;

- gipoparatireoz and psevdogipoparatireoz;

- gipyerparatiryeoz (with bone disease);

- rickets and osteomalyatsiya, associated with malnutrition or suction;

- hypophosphatemic vitamin D-resistant rickets and osteomalacia;

- psevdodefitsitny (vitamin D-dependent) rickets and osteomalyatsiya;

- Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and hypophyseal syndrome);

- renal acidosis.

Dosage regimen

The drug is taken orally. Duration of the course is determined by the physician individually and depends on the nature of the disease and the effectiveness of therapy.

Adults at rickets and osteomalacia, due to failure of exogenous vitamin D, gastrointestinal diseases or prolonged anticonvulsant therapy, the drug is prescribed in a dose 1-3 mg / day.

At gipoparatireoze daily dose is 2-4 g.

At osteodystrophy in patients with chronic renal failure daily dose – to 2 g.

At Fanconi syndrome and renal acidosis drug administered in a daily dose 2-6 g.

At hypophosphatemic rickets and osteomalacia daily dose is 4-20 g.

At postmenopauzne, senilnom, steroidnom and other types of osteoporosis daily dose is 0.5-1 g.

It recommended to begin treatment with the minimum doses specified, controlling 1 weekly levels of calcium and phosphorus in the blood plasma. Dose can be increased to 0.25-0.5 mcg/day to stabilize the biochemical parameters. Upon reaching the lowest effective doses is recommended to control the calcium level in the blood plasma every 3-5 weeks.

Side effect

Metabolism: rarely – hypercalcemia; rarely – a slight increase in HDL cholesterol in the blood plasma. In patients with severe renal impairment may develop hyperphosphatemia.

From the digestive system: anorexia, vomiting, heartburn, stomach ache, nausea, dry mouth, discomfort in epigastric, constipation, diarrhea; rarely – a slight increase in ALT, AST in the plasma.

CNS: rarely – weakness, fatiguability, headache, dizziness, drowsiness.

Cardio-vascular system: rarely – tachycardia.

On the part of the musculoskeletal system: moderate pain in the muscles, bones, joints.

Allergic reactions: rarely – skin rash, itch.

Contraindications

- Hypercalcemia;

— giperfosfatemia (except hyperphosphatemia with hyperparathyroidism);

- Gipermagniemiya;

- hypervitaminosis D;

- Lactation;

- Hypersensitivity to the drug.

FROM caution should be prescribed with nephrolithiasis, atherosclerosis, Heart Failure, renal failure, Sarcoidosis, pulmonary tuberculosis (active form), patients with an increased risk of hypercalcaemia, especially when there urolithiasis.

Pregnancy and lactation

During pregnancy alfacalcidol prescribed only if absolutely indicated and only in the event, if the potential benefit to the mother outweighs the potential risk to the fetus. Hypercalcemia during pregnancy can cause developmental defects in the fetus.

The drug is contraindicated during lactation.

Cautions

During the period of the drug should be regularly (at least 1 times a 3 of the month) to determine the level of calcium in the plasma and urine, oversee the development of therapeutic effect and, if necessary, to carry out a correction dose to prevent the development of hypercalcemia and hypercalciuria.

In the presence of biochemical signs normalization of bone structure (normalization of alkaline phosphatase in the blood plasma) must be a corresponding reduction in the dose Alpha D₃^®-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 the blood plasma. Usually, this period is 1 week. Then treatment may be continued, since the latter half of the applied dose.

Overdose

Early symptoms of hypervitaminosis D (due to hypercalcemia): diarrhea, constipation, nausea, vomiting, dry mouth, anorexia, metallic taste in mouth, hypercalciuria, polyuria, polydipsia, thamuria / nocturia, headache, fatiguability, generalized weakness, myalgia, ostealgias.

Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, clouding of urine, heart rhythm disturbance, itching, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia; rarely – a change of mentality and mood.

Symptoms of chronic vitamin D intoxication: calcification of soft tissues, blood vessels and internal organs (kidney, light), renal and cardiovascular collapse until death, dysplasia in children.

Treatment: the drug should be discontinued. In the early stages of an acute overdose may have a positive effect gastric lavage and / or administration of mineral oil (which helps to reduce absorption and increase the excretion of the drug in the feces). In severe cases, you may need to support healing events – introducing hydration is performed with infusion of saline solutions, some happen – appointment “loop” diuretics, GCS, ʙisfosfonatov, Calcitonin, hemodialysis using solutions with a low calcium content. We recommend that you control the content of electrolytes in the blood, kidney function and condition of the heart (According to ECG), especially in patients, receiving digoxin.

Drug Interactions

In the treatment of osteoporosis Alpha D₃^®-Teva may be administered in combination with estrogen and antiresorptive drugs of different groups.

With simultaneous use of Alpha D₃^®-Teva with digitalis drugs increases the risk of cardiac arrhythmias.

When concomitant administration with barbiturates, anticonvulsants and other drugs, which activate enzymes mikrosomalnogo oxidation in the liver, you must apply the Alpha D₃^®-Teva higher doses.

Absorption of alfacalcidol reduced by combining it with mineral oil (for a long time), kolestiraminom, kolestipolom, sukralfatom, antaцidami, preparations based on albumin.

When applied simultaneously with Alpha D₃^®-Teva antacid increases the risk of hypermagnesemia.

Simultaneous administration of calcium preparations, thiazide diuretics increases the risk of hypercalcemia.

Against the backdrop of Alpha D therapy₃^®-Teva should not be administered vitamin D and derivatives thereof due to the potential additive interaction and increase the risk of hypercalcemia.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.