Alpha D3-Teva Capsules 0,5mkg №30

Dosage form

Capsules

Active ingredient

1 capsule contains:
Active substance
Alfacalcidol - 0.5 mcg.
Excipients
Anhydrous citric acid, propyl gallate, alpha-tocopherol, ethanol, peanut oil.
Soft gelatin capsule contains
Gelatin, glycerol, anidriosorb 85/70, ferric oxide red (E 172), titanium dioxide (E 171), black ink (shellac, ferric oxide black (E 172)).

Packaging

In the blister 10 capsules. In packing 3 blisters.

Mechanism of action

ALPHA D3-TEVA - alfacalcidol - the precursor of the active metabolite of vitamin D 3 - calcitriol. Increases the absorption of Calcium and phosphorus in the intestines, increases their reabsorption in the kidneys, restores the positive calcium balance in the treatment of calcium malabsorption, reduces the concentration of parathyroid hormone in the blood. By acting on both parts of the bone remodeling process (resorption and synthesis), alfacalcidol not only increases bone tissue mineralization, but increases its elasticity by stimulating the synthesis of protein, bone matrix, bone morphogenetic proteins, and bone growth factors, which helps reduce the incidence of fractures.
Elderly patients with endocrine-immune dysfunction, including a deficiency in the production of D-hormone (calcitriol), decrease the total muscle mass (sarcopenia) and develop muscle weakness syndrome (due to impaired normal functioning of the neuromuscular apparatus), which is accompanied by an increase in the risk of falls and the resulting injuries and fractures. A number of studies have shown a significant decrease in the frequency of falls in elderly patients with the use of alfacalcidol.

Indications and usage

Osteoporosis, incl. postmenopausal, senile, steroid.
Osteodystrophy in chronic renal failure.
Hypoparathyroidism and pseudohypoparathyroidism.
Rickets and osteomalacia associated with malnutrition or absorption.
Hypophosphatemic vitamin-D-resistant rickets and osteomalacia.
Pseudo-deficient (vitamin-D-dependent) rickets and osteomalacia.
Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and adiposogenital dystrophy).
Renal acidosis.

Contraindications

Hypersensitivity to alfacalcidol and other components of the drug.
Hypercalcemia.
Hyperphosphatemia (with the exception of hyperphosphatemia in hypoparathyroidism).
Hypermagnesemia.
Hypervitaminosis D.
Pregnancy (I trimester).
Breastfeeding period.
Children under 3 years old.

With care when:
Nephrolithiasis.
Atherosclerosis.
Chronic heart failure.
Chronic renal failure.
Sarcoidosis or other granulomatosis.
Pulmonary tuberculosis (active form).
Pregnancy (II-III trimester).
In patients with an increased risk of developing hypercalcemia, especially in the presence of kidney stones.
Children over 3 years old.

Pregnancy and Breastfeeding

During pregnancy (II-III trimester), alfacalcidol is prescribed only if the expected benefit to the mother exceeds the possible risk to the fetus. In animal experiments, it was shown that calcitriol in doses 4-15 times higher than the recommended doses for humans has a teratogenic effect. Maternal hypercalcemia during pregnancy, associated with prolonged overdose of vitamin D, may cause the fetus to increase sensitivity to vitamin D, parathyroid function suppression, specific elf-like appearance syndrome, mental retardation, aortic stenosis.
The drug is contraindicated for use during breastfeeding.

Dosage and administration

Inside The recommended daily dose of the drug Alpha D 3 -Teva can be taken immediately in one step, you can divide the dose into 2 doses. Therapy can last from 2-3 months to 1 year or more.
The duration of treatment is determined by the doctor for each patient individually.
Adults
When osteomalacia associated with malnutrition or absorption
From 1 to 3 mcg / day for at least 2-3 months.
With hypoparathyroidism
From 2 to 4 mcg / day.
In osteodystrophy in chronic renal failure
From 1 to 2 mcg / day courses for 2-3 months, 2-3 times a year.
With Fanconi syndrome and renal acidosis
From 2 to 6 mcg / day.
When hypophosphatemic osteomalacia
Therapy begins with a dose of 4 mg / day. The maximum daily dose can reach 20 mcg.
When prescribing high doses, it is necessary to consider the issue of switching to a higher dosage of Alpha D 3 -Tev capsules (Alpha D 3 -Tev capsule. 1 μg unit. 30 Teva Pharmaceutical enterprises Ltd.) or other dosage forms of alfacalcidol.
With osteoporosis, including postmenopausal, senile, steroid
From 0.5 to 1 mcg / day. It is recommended to begin treatment with the minimum of the indicated doses, controlling plasma plasma and calcium levels once a week. The dose of the drug can be increased by 0.5 mcg / day to stabilize the biochemical parameters.
Children over 3 years old
With rickets and osteomalacia due to malnutrition or absorption
From 1 to 3 mcg / day for at least 2-3 months.
In osteodystrophy in chronic renal failure
From 0.5 to 1 mcg / day in courses for 2-3 months, 2-3 times a year.
With Fanconi syndrome and renal acidosis
From 2 to 6 mcg / day.
When hypophosphatemic rickets and osteomalacia
Therapy begins with a dose of 1 mg / day.

Adverse reactions

From the digestive organs
Anorexia, nausea, vomiting, heartburn, abdominal pain, dry mouth, discomfort in the epigastrium, constipation, diarrhea.
Rarely - a slight increase in "liver" enzymes.
The nervous system
General weakness, fatigue, headache, dizziness, drowsiness.
Since the cardiovascular system
Tachycardia.
Allergic reactions
Skin rash, itching.
From the musculoskeletal system
Mild pain in muscles, bones, joints.
Laboratory values
Hypercalcemia, a slight increase in high-density lipoprotein. In patients with severe impaired renal function may develop hyperphosphatemia.

Special notes

Therapy should be carried out under constant control of the concentration of calcium and phosphate in the blood (at the beginning of treatment - once a week, when reaching and during the entire period of treatment - the concentration of calcium in plasma and urine every 3-5 weeks), as well as alkaline phosphatase activity ( SCHF) (with CRF - weekly control). When CRF requires a preliminary correction of hyperphosphatemia.
When the level of alkaline phosphatase phosphorus in the blood plasma is normalized, it is necessary to reduce the dose of Alpha D 3 -Tev, which will avoid the development of hypercalcemia. Hypercalcemia or hypercalciuria is corrected by the abolition of the drug and a decrease in calcium intake to normalize the concentration of calcium in the blood plasma. As a rule, this period is 1 week. After normalization, therapy is continued, prescribing half of the last dose applied. It should be borne in mind that sensitivity to vitamin D in different patients is individual, and, in some patients, even taking therapeutic doses can cause the phenomenon of hypervitaminosis.
Children who receive vitamin D for a long time increase the risk of stunting. For the prevention of hypovitaminosis D, most preferably a balanced diet.
In old age, the need for vitamin D may increase due to a decrease in the absorption of vitamin D, a decrease in the ability of the skin to synthesize pro-vitamin D 3, a decrease in the insolation time, and an increase in the incidence of renal failure.

Drug Interactions

In the treatment of osteoporosis, alfacalcidol may be administered in combination with estrogen and drugs that reduce bone resorption.
With the simultaneous use of alfacalcidol with digitalis drugs increases the risk of developing arrhythmias.
Inductors of liver microsomal enzymes (including phenytoin and phenobarbital) reduce, and inhibitors increase the concentration of alfacalcidol in plasma (possibly changing its effectiveness).
The absorption of alfacalcidol is reduced when it is combined with mineral oil (for a long time), Kolestiramine, Colestipol, sucralfate, antacids, and albumin-based preparations.
Acceptance of antacids increases the risk of hypermagneemia and hyperaluminiemia.
Toxic effect weaken Retinol , tocopherol, Ascorbic acid , pantothenic acid, thiamine, riboflavin.
Calcitonin, derivatives of etidronic and pamidronic acids, plicamycin, gallium nitrate and glucocorticosteroids reduce the effect.
Alfacalcidol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.
The simultaneous use of alfacalcidol with calcium preparations, thiazide diuretics can cause hypercalcemia, by increasing the absorption of calcium in the intestine, increasing its reabsorption in the kidneys.
During therapy with alfacalcidol, it is not necessary to prescribe other drugs of vitamin D and its derivatives due to the possible additive interaction and an increased risk of hypercalcemia.

Symptoms of hypervitaminosis early symptoms D (caused giperkaltsiemiey): diarrhea, constipation, nausea, vomiting, dry mouth, anorexia, metallic taste in the mouth, hypercalciuria, polyuria, polydipsia, pollakiuria / nocturia, headache, fatigue, weakness, myalgia, bone pains.
Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, turbidity of the urine, heart rhythm disturbance, skin itch, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia. Rarely - psychosis (change in psyche and mood).
Symptoms of chronic intoxication with vitamin D: calcification of soft tissues, blood vessels and internal organs (kidneys, lungs), renal and cardiovascular failure, even death, growth impairment in children.
Treatment: the drug should be discontinued. In the early stages of acute overdose - gastric lavage, the appointment of mineral oil (petroleum jelly), which reduces the absorption and increase the excretion through the intestines.In severe cases, supportive treatment measures may be required - hydration with the introduction of infusion salt solutions (forced diuresis), in some cases - the appointment of glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and hemodialysis using low calcium solutions. It is recommended to control the content of electrolytes in the blood, kidney function and the state of the heart according to the electrocardiogram, especially in patients receiving Digoxin.

Store at a temperature not higher than 25 ° С.

3 years