Alpha D3, 0.5 mcg capsules 60 pcs

How to take, the dosage

Overly, regardless of meals, without chewing, with plenty of fluid, once a day. Recommended daily dose of the drug Alpha D 3 -Teva can be taken all at once, or the dose can be divided into 2 doses. Therapy may last from 2-3 months to 1 year or more.

The duration of treatment is determined by the doctor for each patient individually.

• Adults
  • For osteomalacia associated with malnutrition or malabsorption

    From 1 to 3 mcg/d for at least 2 to 3 months.

  • Hypoparathyroidism

    From 2 to 4 mcg/d.

  • For osteodystrophy in CVD

    From 1 to 2 mcg/d for 2-3 months 2-3 times a year.

  • Fanconi syndrome and renal acidosis

    From 2 to 6 mcg/d.

  • Hypophosphatemic osteomalacia

    Therapy starts with a dose of 4 mcg/day. The maximum daily dose can reach 20 mcg.

  If high doses are prescribed, consider switching to a higher dosage of Alpha D3-Teva capsules (Alpha D3-Teva capsules 1 mcg disp. 30 Teva Pharmaceuticals Ltd.) or other dosage forms of alphacalcidol.

  • In osteoporosis including postmenopausal, senile, steroid

    From 0.5 to 1 mcg/day. It is recommended to start therapy with the lowest of these doses, controlling the calcium and phosphorus levels in blood plasma once a week. The drug dose can be increased by 0.5 mcg/day until the biochemical parameters are stabilized.

    Children over 3 years of age

    • For rickets and osteomalacia associated with malnutrition or malabsorption

      From 1 to 3 mcg/day for at least 2-3 months.

    • For osteodystrophy in CVD

      From 0.5 to 1 mcg/d for 2-3 months 2-3 times a year.

    • Fanconi syndrome and renal acidosis

      From 2 to 6 mcg/d.

In hypophosphatemic rickets and osteomalacia

Therapy starts with a dose of 1 mcg/day.

Interaction

In the treatment of osteoporosis alfacalcidol may be prescribed in combination with estrogens and drugs that reduce bone resorption.

The simultaneous use of alfacalcidol with foxglove drugs increases the risk of arrhythmia.

The inducers of microsomal liver enzymes (including phenytoin and phenobarbital ) decrease and inhibitors increase the plasma concentration of alfacalcidol (its effectiveness may change).

Alfacalcidol absorption is decreased when co-administered with mineral oil (for a long time), colestyramine, colestipol, sucralfate, antacids, albumin-based preparations.

The use of antacids increases the risk of hypermagnesemia and hyperaluminemia.

The toxic effects are weakened by retinol , tocopherol , ascorbic acid , pantothenic acid , thiamine , riboflavin .
Calcitonin, derivatives of etidronic and pamidronic acids, plikamycin, gallium nitrate and glucocorticosteroids reduce the effect.
Alfacalcidol increases absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.

Concomitant use of alfacalcidol with calcium preparations, thiazide diuretics may cause hypercalcemia due to increased absorption of calcium in intestine, increased reabsorption in kidneys.

With alfacalcidol therapy other medicinal products of vitamin D and its derivates should not be administered because of possible additive interaction and increase of risk of hypercalcaemia development.

Special Instructions

The therapy should be carried out under constant control of calcium and phosphate concentrations in blood (at the beginning of treatment – once a week, when reaching and during the whole period of treatment – calcium concentration in plasma and urine every 3-5 weeks), as well as activity of alkaline phosphatase (ALP) (in CPN – weekly control). In CKD it is required preliminary correction of hyperphosphatemia.

When plasma alkaline phosphatase content is normalized, the dose of the drug Alpha D 3 -Teva should be decreased to avoid the development of hypercalcemia. Hypercalcemia or hypercalciuria is corrected by discontinuation of the drug and reduction of calcium intake until normalization of plasma calcium concentration. As a rule, this period is 1 week. After normalization, therapy is continued by administering half of the last dose used. It should be kept in mind that sensitivity to vitamin D is individual for different patients and even therapeutic doses may cause hypervitaminosis in some patients.

In children receiving vitamin D for a long time the risk of stunting increases. For the prevention of hypovitaminosis D, a balanced diet is most preferable.

In old age, the need for vitamin D may increase due to decreased absorption of vitamin D, decreased ability of the skin to synthesize provitamin D 3 , decreased insolation time, and increased frequency of renal failure.

Contraindications

• hypercalcemia;
• hyperphosphatemia (except hyperphosphatemia in hyperparathyroidism);
• hypermagnesemia;
• hypervitaminosis D;
• pregnancy;
• lactation period (breastfeeding);
• children under 3 years of age;
• high sensitivity to alphacalcidol and other components of the drug.

With caution The drug should be prescribed in nephrolithiasis, atherosclerosis, chronic heart failure, chronic renal failure, sarcoidosis or other granulomatosis, pulmonary tuberculosis (active form), patients with increased risk of hypercalcemia, especially in the presence of urolithiasis, children over 3 years old.

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Side effects

Nervous system disorders:general weakness, fatigue, headache, dizziness, somnolence.

Allergic reactions:skin rash, itching.

Musculoskeletal side:moderate pain in muscles, bones, joints.

Laboratory findings:hypercalcemia, slight increase in HDL concentration; possible development of hyperphosphatemia (in patients with significant renal dysfunction).

Systemic diseases: tachycardia, increased BP.

Gastrointestinal system disorders:anorexia, vomiting, heartburn, abdominal pain, nausea, dry oral mucosa, discomfort in epigastric region, constipation, diarrhea, slight increase of liver enzymes activity.

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Overdose

Symptoms:Early symptoms of hypervitaminosis D (due to hypercalcemia): Diarrhea, constipation, nausea, vomiting , dry mouth, anorexia , metallic taste in mouth, hypercalciuria, polyuria, polydipsia, pollakiuria/nicturia, headache, fatigue, general weakness, myalgia , bone pain.

Late symptoms of hypervitaminosis D:dizziness, confusion, drowsiness, blurred urine, heart rhythm disorders, skin itching, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia. Rarely – psychosis (change of mind and mood).

The symptoms of chronic vitamin D intoxication: calcification of soft tissues, blood vessels and internal organs (kidneys, lungs), renal and cardiovascular failure up to death, growth disorders in children.

Treatment:The drug should be discontinued. In the early terms of acute overdose – gastric lavage, prescription of mineral oil (Vaseline), which helps to reduce absorption and increase excretion through the intestine. In severe cases it may be necessary to carry out supportive therapeutic measures – hydration with infusion of saline solutions (forced diuresis), in some cases – prescription of glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and hemodialysis with solutions with low calcium content. It is recommended to monitor the blood electrolyte content, renal function and cardiac status according to electrocardiogram especially in patients receiving digoxin.

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Pregnancy use

In 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.

Hypercalcemia in the mother during pregnancy associated with prolonged overdose of vitamin D may cause fetal hypersensitivity to vitamin D, suppression of parathyroid function, specific elf-like appearance syndrome, mental retardation, and aortic stenosis.

The drug is contraindicated for use during breastfeeding.

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