Alpha D3, 0.25 mcg capsules 60 pcs

Pharmgroup:

Vitamin – calcium-phosphorus metabolism regulator.

Pharmic action:

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

Concerning 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 promotes reduction of 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 quickly absorbed from the gastrointestinal 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

Osteoporosis, Bone fractures, bone fragility, rickets

• Osteoporosis, including postmenopausal, senile, steroid.
• Osteodystrophy in chronic renal failure.
• Hypoparathyroidism and pseudohypoparathyroidism.
• Rachitis 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

Alfacalcidol

Composition

Active ingredient:

Alfacalcidol – 0.25 mcg.

Associates:

citric acid anhydrous – 0.015 mg,

propyl gallate – 0.02 mg,

D,L-α-tocopherol (vit. E) – 0.02 mg,

ethanol absolute – 1.145 mg,

peanut butter – up to 100 mg.

The composition of the soft gelatin capsule:

gelatin – 48.55 mg, glycerol 85% – 11.7 mg, anidrisorb 85/70 – 7.92 mg (sorbitol – 24-40%, sorbitan – 20-30%, mannitol – 0-6%, higher polyols – 12.5-19%, water – 15-17%), iron oxide red (E172) – 0.54 mg.

Composition of A10379 food black ink:

Hellack – 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.

• 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 Pharmaceutical Enterprises 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 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.

    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 may be prescribed in combination with estrogens and antiresorptive drugs of different groups.

Concomitant use of Alpha D₃-Teva with foxglove drugs increases the risk of cardiac rhythm disturbances.

In concomitant use with barbiturates, anticonvulsants and other drugs that activate enzymes of microsomal oxidation in the liver, a higher dose of Alfa D₃-Teva should be used.

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

When used concomitantly with Alpha D₃-Teva antacids or laxative dialysis increases the risk of hypermagnesemia.

The simultaneous use of calcium preparations, thiazide diuretics increase the risk of hypercalcemia.
Vitamin D and its derivates should not be used during the therapy with Alfa D₃-Teva because of possible additive interaction and increased risk of hypercalcemia.

Special Instructions

With caution prescribe the drug to patients with a tendency to hypercalcemia. During the period of using the drug the plasma calcium level should be determined regularly.

If there are biochemical signs of normalization of bone structure (normalization of plasma ALP levels), the appropriate reduction of the dose of Alpha D₃-Teva is necessary to avoid the development of hypercalcemia.

Hypercalcemia or hypercalciuria can be corrected by withdrawing the drug and reducing calcium intake until plasma calcium concentrations normalize. This period is usually 1 week. Therapy may then be continued, starting with half of the last dose used.

Contraindications

• Hypersensitivity to alfacalcidol and other drug components.
• Hypercalcemia.
• Hyperphosphatemia (except hyperphosphatemia in hypoparathyroidism).
• Hypermagnesemia.
• Hypervitaminosis D.
• Pregnancy (first trimester).
• Breastfeeding period.
• Children under 3 years.

With caution in:

• Nephrolithiasis.
• Atherosclerosis .
• Cronic heart failure .
• Chronic renal failure.
• Sarcoidosis or other granulomatosis.
• Pulmonary tuberculosis (active form).
• Pregnancy (II-III trimester).
• In patients at increased risk of hypercalcemia, especially if renal calculi disease is present.
• Children over 3 years of age.

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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

  General weakness, fatigue, headache, Dizziness, drowsiness.

• Cardiovascular system

  Tachycardia.

• Allergic reactions

  Skin rash, itching.

• Motor system

  Moderate pain in muscles, bones, joints.

• Laboratory findings

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

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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, 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, 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 – administration of glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and hemodialysis with solutions of low calcium content. It is recommended to monitor 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 experiments on animals 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 can cause fetal hypersensitivity to vitamin D, suppression of parathyroid function, specific elf-like appearance syndrome, mental retardation, and aortic stenosis.

The drug is contraindicated during breastfeeding.

Similarities

Oxydevit