Alfacalcidol

Brand Teva

In stock 1554 Items

Available since: 2019-09-19

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Clinical Pharmacology

Alpha D₃-Teva is a drug that regulates calcium and phosphorus metabolism. Increases the absorption of calcium and phosphorus in the intestines, increases their reabsorption in the kidneys, enhances bone mineralization, reduces the level of parathyroid hormone in the blood.
Alpha D₃Teva restores the positive calcium balance in the treatment of calcium malabsorption, thereby reducing the intensity of bone resorption, which helps to reduce the incidence of fractures.
In the course application of the drug, there is a decrease in bone and muscle pain associated with impaired calcium-phosphorus metabolism, improved coordination of movements.

Indications

Osteoporosis, incl. postmenopausal, senile, steroid.
Osteodystrophy in chronic renal failure.
Hypoparathyroidism and pseudohypoparathyroidism.
Rickets and osteomalacia associated with malnutrition or absorption.
Hypophosphatemic vitamin-D-resistant rickets and osteomalacia.
Pseudo-deficient (vitamin-D-dependent) rickets and osteomalacia.
Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and adiposogenital dystrophy).
Renal acidosis.

Composition

Active ingredient: alfacalcidol - 1 mcg.

Excipients: anhydrous citric acid - 0.015 mg, propyl gallate - 0.02 mg, D, L-α-tocopherol (Vit. E) - 0.02 mg, ethanol absolute - 1.144 mg, peanut oil - up to 100 mg.

The composition of soft gelatin capsules: gelatin - 48.27 mg, glycerol 85% - 11.88%, anidribsorb 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 food black ink A10379: shellac - 54%, ferric oxide black (E172) - 46%.

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Inside The recommended daily dose of Alpha D₃- 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
- When osteomalacia associated with malnutrition or absorption
  From 1 to 3 mcg / day for at least 2-3 months.
- With hypoparathyroidism
  From 2 to 4 mcg / day.
- With osteodystrophy in chronic renal failure
  From 1 to 2 mcg / day course for 2-3 months, 2-3 times a year.
- With Fanconi syndrome and renal acidosis
  From 2 to 6 mcg / day.
- When hypophosphatemic osteomalacia
  Therapy begins with a dose of 4 mg / day. The maximum daily dose can reach 20 mcg.
When prescribing high doses, consideration should be given to switching to a higher dosage of Alpha D capsules.₃-Teva (Alpha D₃-Teva caps. 1 mcg pack. 30 Teva Pharmaceutical Enterprises Ltd.) or other medicinal forms of alfacalcidol.
- With osteoporosis, including postmenopausal, senile, steroid
  From 0.5 to 1 mcg / day. It is recommended to begin treatment with the minimum of the indicated doses, controlling the level of calcium phosphorus to the blood plasma once a week. The dose of the drug can be increased by 0.5 mcg / day to stabilize the biochemical parameters.
  Children over 3 years old
  - With rickets and osteomalacia due to malnutrition or absorption
    From 1 to 3 mcg / day for at least 2-3 months.
  - With osteodystrophy in chronic renal failure
    From 0.5 to 1 mcg / day in courses for 2-3 months, 2-3 times a year.
  - With Fanconi syndrome and renal acidosis
    From 2 to 6 mcg / day.

When hypophosphatemic rickets and osteomalacia

Adverse reactions

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

Rarely - a slight increase in "liver" enzymes.

The nervous system
General weakness, fatigue, headache, Dizziness, drowsiness.

Since the cardiovascular system
Tachycardia.

Allergic reactions
Skin rash, itching.

From the musculoskeletal system
Mild pain in muscles, bones, joints.

Laboratory values

Hypercalcemia, a slight increase in high-density lipoprotein. In patients with severe impaired renal function, hyperphosphatemia may develop.

With care when:

Contraindications

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 in the presence of kidney stones.
Children over 3 years old.

Drug interactions

In the treatment of osteoporosis, alfacalcidol can be administered in combination with estrogens and drugs that reduce bone resorption.
With the simultaneous use of alfacalcidol with digitalis drugs increases the risk of arrhythmias.
Inductors of liver microsomal enzymes (including phenytoin and phenobarbital) reduce, and inhibitors increase the concentration of alfacalcidol in plasma (possibly changing its effectiveness).
Absorption of alfacalcidol decreases when it is combined with mineral oil (for a long time), colestiramine, colestipol, sucralfate, antacids, and albumin-based preparations.
Acceptance of antacids increases the risk of hypermagneemia and hyperaluminiemia.
Toxic effect weaken retinol, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin.
Calcitonin, derivatives of etidronic and pamidronic acids, plicamycin, gallium nitrate and glucocorticosteroids reduce the effect.
Alfacalcidol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.
The simultaneous use of alfacalcidol with calcium preparations, thiazide diuretics can cause hypercalcemia, by increasing the absorption of calcium in the intestines, increasing its reabsorption in the kidneys.
During therapy with alfacalcidol, it is not necessary to prescribe other drugs of vitamin D and its derivatives because of the possible additive interaction and an increased risk of hypercalcemia.

Pregnancy and Lactation

During 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 has been shown that calcitriol in doses 4-15 times higher than the recommended doses for humans has a teratogenic effect. Maternal hypercalcemia during pregnancy, associated with prolonged overdose of vitamin D, may cause the fetus to increase sensitivity to vitamin D, parathyroid function suppression, specific elf-like appearance syndrome, mental retardation, aortic stenosis.
The drug is contraindicated for use during breastfeeding.

Special instructions

Therapy should be carried out under constant control of the concentration of calcium and phosphate in the blood (at the beginning of treatment - once a week, when reaching and during the entire period of treatment - the concentration of calcium in plasma and urine every 3-5 weeks), as well as alkaline phosphatase activity ( SCHF) (with CRF - weekly control). When CRF requires a preliminary correction of hyperphosphatemia.

With the normalization of the content of alkaline phosphatase plasma in the blood plasma, it is necessary to reduce the dose of the drug Alpha D₃- Teva, which will avoid the development of hypercalcemia. Hypercalcemia or hypercalciuria is corrected by the abolition of the drug and a decrease in calcium intake to normalize the concentration of calcium in the blood plasma. As a rule, this period is 1 week. After normalization, therapy is continued, prescribing half of the last dose applied. It should be borne in mind that sensitivity to vitamin D in different patients is individual, and, in some patients, even taking therapeutic doses can cause the phenomenon of hypervitaminosis.

Children who receive vitamin D for a long time increase the risk of stunting. For the prevention of hypovitaminosis D, most preferably a balanced diet.

In old age, the need for vitamin D may increase due to a decrease in the absorption of vitamin D, a decrease in the skin’s ability to synthesize pro-vitamin D₃, reduce insolation time, increase the frequency of renal failure.

Overdosage

Symptoms of hypervitaminosis early symptoms D (caused giperkaltsiemiey): diarrhea, constipation, nausea, vomiting, dry mouth, anorexia, metallic taste in the mouth, hypercalciuria, polyuria, polydipsia, pollakiuria / nocturia, headache, fatigue, weakness, myalgia, bone pains.
Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, turbidity of the urine, heart rhythm disturbance, skin itch, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia. Rarely - psychosis (change of mind and mood).
Symptoms of chronic vitamin D intoxication: calcification of soft tissues, blood vessels and internal organs (kidneys, lungs), renal and cardiovascular insufficiency, even death, growth disorder in children.
Treatment: the drug should be discontinued. In the early stages of acute overdose - gastric lavage, the appointment of mineral oil (petrolatum), to reduce the absorption and increase the excretion through the intestines. In severe cases, supportive treatment measures may be required - hydration with the introduction of infusion salt solutions (forced diuresis), in some cases - the appointment of glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and hemodialysis using low calcium solutions. It is recommended to control the content of electrolytes in the blood, kidney function and the state of the heart according to the electrocardiogram, especially in patients receiving digoxin.