Alpha D3, 1 mcg capsules 30 pcs

Alpha D3-Teva is a vitamin, regulator of calcium-phosphorus metabolism. It is a precursor of the active metabolite of vitamin D3 – calcitriol. It increases absorption of calcium and phosphorus in intestine, increases their reabsorption in kidneys, restores positive calcium balance in treatment of calcium malabsorption syndrome, reduces parathyroid hormone in blood.

Increasing both parts of bone remodeling process (resorption and synthesis) alfacalcidol not only increases mineralization of bone tissue, but also increases its elasticity by stimulating synthesis of bone matrix proteins, bone morphogenetic proteins and bone growth factors which helps to decrease fracture frequency.

In elderly patients with endocrine-immune dysfunction, including deficiency of D-hormone production (calcitriol), a decrease of total muscle mass (sarcopenia) and the appearance of muscle weakness syndrome (due to the disturbance of normal neuromuscular system functioning) occur, accompanied by an increased risk of falls and the resulting injuries and fractures. A number of studies have shown a significant reduction in the incidence of falls in elderly patients with alfacalcidol.

Pharmacokinetics:

Intake

After oral administration alfacalcidol is rapidly absorbed from the GI tract. Cmax in plasma is reached 8-12 hours after a single dose of alfacalcidol.

Alfacalcidol is converted into calcitriol (1.25-dihydroxycalciferol) in liver by hydroxylation on carbon atom 25, and process of hydroxylation is very fast (substrate-dependent character). Unlike native vitamin D alfacalcidol does not require hydroxylation in kidneys, therefore it is effective even in patients with decreased activity of renal 1-alpha-hydroxylase (kidney pathology, old age).

Elimination

The T1/2 is 35 h. It is excreted by the kidneys and through the intestine with the bile in approximately equal proportions.

Indications

Active ingredient

Composition

Active ingredient:

alfacalcidol – 1 mcg.

Excipients:

citric acid anhydrous – 0.015 mg,

propyl gallate – 0.02 mg,

D,L-α-tocopherol (Vit. E) – 0.02 mg,

Ethanol absolute – 1.144 mg,

Peanut butter – up to 100 mg.

The composition of the soft gelatin capsule: gelatin – 48.27 mg, glycerol 85% – 11.88%, anidrisorb 85/70 – 7.88 mg (sorbitol – 24-40%, sorbitan – 20-30%, mannitol – 0-6%, higher polyols – 15.5-19%, water – 15-17%), iron oxide yellow (E172) – 0.05 mg, titanium dioxide (E171) – 0.68 mg.

The composition of black food ink A10379: shellac – 54%, iron oxide 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 Pharmaceuticals Ltd.) or other dosage forms of alphacalcidol.

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.

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.

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 be changed).

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

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, etidronic and pamidronic acid derivatives, plikamycin, gallium nitrate and glucocorticosteroids reduce the effect.

Alfacalcidol increases absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.

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

With alfacalcidol therapy, other vitamin D drugs and their derivatives should not be prescribed because of possible additive interaction and increased risk of hypercalcemia.

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 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. To prevent 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: nephrolithiasis; atherosclerosis; chronic heart failure; chronic renal failure; sarcoidosis or other granulomatosis; pulmonary tuberculosis (active form); patients at increased risk of hypercalcemia, especially renal stone disease; children over 3 years old.

Side effects

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

Rarely, a slight increase in “liver” enzymes.

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

Cardiovascular system: Tachycardia.

Allergic reactions: Skin rash, itching.

Musculoskeletal system: Moderate pain in muscles, bones, joints.

Laboratory measures: Hypercalcemia, slight elevation of high-density lipoproteins. In patients with significant renal dysfunction, the development of hyperphosphatemia is possible.

Overdose

Symptoms: early symptoms of hypervitaminosis D (due to hypercalcemia): diarrhea, constipation, nausea, vomiting, dry mouth, anorexia, metallic taste in the 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 (changes in 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, 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 blood electrolytes, renal function and cardiac status by electrocardiogram, especially in patients receiving digoxin.

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