Alpha D3, 0.5 mcg capsules 30 pcs

Alpha D₃-Teva is a drug that regulates calcium and phosphorus metabolism. It increases the absorption of calcium and phosphorus in the intestine, increases their reabsorption in the kidneys, increases bone mineralization, reduces blood levels of parathyroid hormone.

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

With a course of use of the drug a decrease of bone and muscle pain associated with impaired phosphorus-calcium metabolism, improvement of coordination of movements is noted.

Indications

Osteoporosis, including postmenopausal, senile, steroid.

Osteodystrophy in chronic renal failure.

Hypoparathyroidism and pseudohypoparathyroidism.

Rickets and osteomalacia associated with nutritional or absorption deficiencies.

Hypophosphatemic vitamin-D-resistant rickets and osteomalacia.

Pseudodeficient (vitamin-D-dependent) rickets and osteomalacia.

Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, tardive rickets and adiposogenital dystrophy).
Renal acidosis.

Active ingredient

Composition

Active substance:

Alfacalcidol – 0.5 mcg.

Auxiliary substances:

citric acid anhydrous – 0.015 mg,

propyl gallate – 0.02 mg,

α-tocopherol (vit. E) – 0.02 mg,

ethanol – 1.145 mg,

peanut butter – up to 100 mg.

Composition of the 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.

Composition of black ink:

shellac – 54%, iron oxide dye black (E172) – 46%

How to take, the dosage

Ingestion. 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.

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

From 2 to 4 mcg/d.

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

From 2 to 6 mcg/d.

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 Pharmaceutical Enterprises Ltd) or other dosage forms of alphacalcidol.

From 0.5 to 1 mcg/day. It is recommended to start treatment 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.

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

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

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.

In concomitant use of alfacalcidol with foxglove preparations the risk of arrhythmia increases.
Inducers of microsomal liver enzymes (including phenytoin and phenobarbital ) decrease, and inhibitors – increase the concentration of alfacalcidol in plasma (its effectiveness may be changed).

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.

Simultaneous 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 derivatives should not be prescribed due to possible additive interaction and increased risk of hypercalcaemia.

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 alkaline phosphatase (ALP) activity (in CKD – weekly control). In CKD it is required preliminary correction of hyperphosphatemia.

When plasma ALP 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 cancelling the drug and reducing 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 in some patients even therapeutic doses may cause hypervitaminosis.

In children receiving vitamin D for a long time, there is an increased risk of growth retardation. For the prevention of hypovitaminosis D, a balanced diet is 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

With caution in:

Side effects

Anorexia, nausea, vomiting, heartburn, abdominal pain, dry mouth, feeling of discomfort in the epigastric region, constipation, diarrhea.

Rarely, a slight increase in “liver” enzymes.

General weakness, fatigue, headache, Dizziness, drowsiness.

Tachycardia.

Skin rash, itching.

Moderate pain in muscles, bones, joints.

Hypercalcemia, mild elevation of high-density lipoproteins . In patients with significant renal dysfunction, hyperphosphatemia is possible.

Overdose

Symptoms: early symptoms of hypervitaminosis D (caused by 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, somnolence, blurred urine, abnormal heart rhythm, 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 days of acute overdose – gastric lavage, administration 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 medical 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.

We recommend monitoring blood electrolytes, renal function and cardiac status by electrocardiogram especially in patients receiving digoxin.

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 recommended doses for humans has teratogenic effect.

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

The drug is contraindicated for use during breastfeeding.

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