Alpha D3-Teva, 0.25 mcg 30 pcs.

$12.00
(0) Write a Review

Product Description

Composition

Active substance:

alfacalcidol - 0.25 mcg.

Excipients:

citric acid anhydrous - 0.015 mg,

propyl gallate - 0.02 mg,

D, L-α-tocopherol (vit. E) - 0.02 mg,

ethanol absolute - 1.145 mg,

peanut butter - up to 100 mg.

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 black food ink A10379:

shellac - 54%,

iron oxide black (E172) - 46%.

pharmachologic effect

Pharmaceutical group:

 vitamin - calcium-phosphorus metabolism regulator.

Pharmaceutical action:

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

Acting on both parts of the bone remodeling process (resorption and synthesis), alfacalcidol not only increases bone mineralization, but also increases its elasticity by stimulating the synthesis of bone matrix proteins, bone morphogenetic proteins, and bone growth factors, which helps to reduce the incidence of fractures.

In elderly patients, against the background of endocrine-immune dysfunction, including a deficiency in the production of D-hormone (calcitriol), there is a decrease in total muscle mass (sarcopenia) and the appearance of muscle weakness syndrome (due to disruption of the normal functioning of the neuromuscular apparatus), which is accompanied by an increase in the risk of falls and related injuries and fractures. Several studies have shown a significant reduction in the incidence of falls in elderly patients when using alfacalcidol.

Pharmacokinetics: 

Suction

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

Metabolism

The conversion of alfacalcidol to calcitriol (1.25-dihydroxycolecalciferol) occurs in the liver by hydroxylation at the 25 carbon atom, and the hydroxylation process occurs very quickly (it is substrate-dependent). Unlike native vitamin D, alfacalcidol does not need hydroxylation in the kidneys, therefore it is effective even in patients with reduced activity of renal 1-alpha-hydroxylase (kidney disease, old age).

Withdrawal

T1 / 2 is 35 hours. It is excreted by the kidneys and through the intestines with bile in approximately equal proportions.

Indications

Osteoporosis, incl. postmenopausal, senile, steroid.

Osteodystrophy in chronic renal failure.

Hypoparathyroidism and pseudohypoparathyroidism.

Rickets and osteomalacia associated with malnutrition or malabsorption.

Hypophosphatemic vitamin D-resistant rickets and osteomalacia.

Pseudo-deficiency (vitamin D-dependent) rickets and osteomalacia.

Fanconi's syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and adiposogenital dystrophy).

Renal acidosis.

Application during pregnancy and lactation

During pregnancy (II-III trimester), alfacalcidol is prescribed only if the expected benefit to the mother outweighs the possible risk to the fetus.

Experiments on animals have 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 the fetus to increase sensitivity to vitamin D, suppression of parathyroid function, syndrome of a specific elf-like appearance, mental retardation, aortic stenosis.

The drug is contraindicated for use during breastfeeding.

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 of age.

With caution 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 with kidney stones.
  • Children over 3 years of age.

Side effects

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

    Rarely - a slight increase in "liver" enzymes.

  • From the nervous system

    General weakness, fatigue, headache, dizziness, drowsiness.

  • On the part of the cardiovascular system

    Tachycardia.

  • Allergic reactions

    Skin rash, itching.

  • From the musculoskeletal system

    Moderate pain in muscles, bones, joints.

 

  • Laboratory indicators

    Hypercalcemia, a slight increase in high density lipoproteins. In patients with severe renal impairment, hyperphosphatemia may develop.

Interaction

In the treatment of osteoporosis, it can be prescribed in combination with estrogens and antiresorptive drugs of different groups.
With the simultaneous use of Alpha D 3 -Teva with digitalis preparations, the risk of developing cardiac arrhythmias increases.
When administered simultaneously with barbiturates, anticonvulsants and other drugs that activate enzymes of microsomal oxidation in the liver, it is necessary to use a higher dose of Alpha D 3- Teva.

The absorption of alfacalcidol decreases when it is used together with mineral oil (for a long time), cholestyramine, colestipol, sucralfate, antacids, and albumin-based preparations.

When used simultaneously with Alpha D 3 -Teva antacids or laxative dialysis, the risk of developing hypermagnesemia increases.
The simultaneous administration of calcium preparations, thiazide diuretics increases the risk of hypercalcemia.

During therapy with Alpha D 3 -Teva, vitamin D and its derivatives should not be prescribed because of the possible additive interaction and an increased risk of hypercalcemia.

How to take, course of administration and dosage

Inside. The recommended daily dose of the drug Alpha D  3-  Teva can be taken immediately in one dose, 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
    • For osteomalacia associated with malnutrition or malabsorption

      1 to 3 mcg / day for a minimum of 2-3 months.

    • With hypoparathyroidism

      2 to 4 mcg / day.

    • With osteodystrophy in chronic renal failure

      From 1 to 2 mcg / day in courses for 2-3 months 2-3 times a year.

    • With Fanconi syndrome and renal acidosis

      2 to 6 mcg / day.

    • With hypophosphatemic osteomalacia

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

    When prescribing high doses, it is necessary to consider switching to a higher dosage of Alpha D 3-  Teva capsules (Alpha D 3-  Teva caps. 1 mcg pack. 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 start treatment with the minimum of the indicated doses, monitoring once a week the level of calcium-phosphorus in the blood plasma. The dose of the drug can be increased by 0.5 μg / day until the biochemical parameters stabilize.

      Children over 3 years old
      • For rickets and osteomalacia associated with malnutrition or malabsorption

        1 to 3 mcg / day for a minimum of 2-3 months.

      • With osteodystrophy in chronic renal failure

        From 0.5 to 1 μg / day in courses for 2-3 months 2-3 times a year.

      • With Fanconi syndrome and renal acidosis

        2 to 6 mcg / day.

With hypophosphatemic rickets and osteomalacia 

Therapy begins with a dose of 1 μg / day.

 

 

 

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 / nocturia, headache, weakness, fatigue, generalized bone pain.

Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, cloudy urine, cardiac arrhythmias, pruritus, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia. Rarely - psychosis (changes in the psyche and mood).

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

Treatment: the drug should be canceled. In the early stages of an acute overdose - gastric lavage, the appointment of mineral oil (vaseline), which helps to reduce absorption and increase excretion through the intestines. In severe cases, it may be necessary to carry out supportive therapeutic measures - hydration with the introduction of infusion saline solutions (forced diuresis), in some cases - the appointment of glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and hemodialysis using solutions with a low calcium content.

It is recommended to monitor the content of electrolytes in the blood, kidney function and heart condition according to the electrocardiogram data, especially in patients receiving digoxin.

Special instructions

Therapy should be carried out under constant monitoring of the concentration of calcium and phosphate in the blood (at the beginning of treatment - once a week, upon reaching and during the entire period of treatment - the concentration of calcium in plasma and urine every 3-5 weeks), as well as the activity of alkaline phosphatase ( ALP) (for chronic renal failure - weekly control). With CRF, preliminary correction of hyperphosphatemia is required.

With the normalization of the ALP content in the blood plasma, it is necessary to reduce the dose of the drug Alpha D   -Teva, which will avoid the development of hypercalcemia. Hypercalcemia or hypercalciuria is corrected by discontinuation of the drug and a decrease in calcium intake until the plasma calcium concentration normalizes.

Typically, this period is 1 week. After normalization, therapy is continued, appointing half of the last dose used. It should be borne in mind that the sensitivity to vitamin D in different patients is individual, and in some patients, even taking therapeutic doses can cause hypervitaminosis.

Children who receive vitamin D for long periods of time are at increased risk of stunting. For the prevention of hypovitaminosis D, a balanced diet is most preferable.

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 provitamin D   , a decrease in the time of sun exposure, and an increase in the incidence of renal failure.

Release form

Capsules are soft gelatinous, reddish-brown, oval, printed with "0.25" black paint; the contents of the capsules are a pale yellow oil solution.

Storage conditions

At a temperature not exceeding 25 ° C

Shelf life

3 years

Customers Also Viewed

Dietress,  100 pcs.

Materia Medica Holding, Russia

$40.00

Briefly about the product Dietress is a drug for long-term therapy of patients with overweight or o…

Beres  30 ml

Beres, Hungary

$10.00

Composition 1 ml (18 drops for oral administration) contains: active ingredients: Iron - 2 mg / ml …

ATP, 1%, 1 ml, 10 pcs.

Ellara, Russia

$10.00

Composition 1 ml of the drug (1 ampoule) contains: Sodium adenosine triphosphate disubstituted (in …