Alpha D3, 0.5mcg capsules 60pcs

Composition

1 capsule contains:

Active ingredient:  

alfacalcidol – 0.5 mcg.

Auxiliary substances:

citric acid anhydrous-0.015 mg,

propyl gallate-0.02 mg,

alpha-tocopherol (vit. E) – 0.02 mg,

ethanol-1.145 mg,

peanut butter-up to 100 mg.

Composition of soft gelatin capsule:

gelatin – 48.35 mg,

glycerol – 11.81 mg,

antiserb 85/70 – 7.89 mg (sorbitol – 24-40%, sorbitan – 20-30%, mannitol – 0-6%, higher polyols – 12.5-19%, water – 15-17%),

dye iron oxide red (E 172) – 0.043 mg,

titanium dioxide (E 171) – 0.65 mg.

The composition of black ink:

shellac-54%,

iron oxide black dye (E 172) – 46%.

Pharmacological action

of Alpha D 3-Teva-regulating calcium-phosphorus metabolism.

Pharmacodynamics

Alfacalcidol (1α-hydroxyvitamin D3) is rapidly converted in the liver to 1,25-dihydroxyvitamin D3, an active metabolite of vitamin D (calcitriol), which acts as a regulator of calcium and phosphorus metabolism. 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 and reduces the concentration of parathyroid hormone in the blood. By affecting 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 reduce the incidence of fractures.

In elderly patients with endocrine-immune dysfunction, including D-hormone (calcitriol) production deficiency, there is a decrease in total muscle mass (sarcopenia) and the appearance of muscle weakness syndrome (due to a violation of the normal functioning of the neuromuscular apparatus), which is accompanied by an increased risk of falls and resulting injuries and fractures. A number of studies have shown a significant reduction in the incidence of falls in elderly patients when using alfacalcidol. Alfacalcidol stimulates the regeneration of muscle fibers, which restores lost muscle tone.

Pharmacokinetics

Suction.  After oral use, alfacalcidol is rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma is reached in 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 25 carbon atoms, and the hydroxylation process occurs very quickly (it is substrate-dependent). Unlike native vitamin D, alfacalcidol does not need to be hydroxylated in the kidneys, so it is effective even in patients with reduced renal 1-alpha-hydroxylase activity (kidney pathology, elderly age).

Indications

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

Use during 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.

Animal experiments 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 increased sensitivity to vitamin D in the fetus, suppression of parathyroid function, specific elf-like appearance syndrome, mental retardation, and aortic stenosis.

The drug is contraindicated for use during breastfeeding.

Contraindications

• hypercalcemia;
• hyperphosphatemia (except for hyperphosphatemia in hyperparathyroidism);
• hypermagnesemia;
• hypervitaminosis D;
• pregnancy;
• lactation (breastfeeding);
• children under 3 years of age;
• hypersensitivity to alfacalcidol and other components of the drug.

With caution, the drug should be prescribed for nephrolithiasis, atherosclerosis, chronic heart failure, chronic renal failure, sarcoidosis or other granulomatoses, pulmonary tuberculosis (active form), patients with an increased risk of hypercalcemia, especially in the presence of urolithiasis, children over the age of 3 years.

Side effects

Nervous system disorders: general weakness, fatigue, headache, dizziness, drowsiness.

Allergic reactions: skin rash, itching.

From the musculoskeletal system: moderate pain in the muscles, bones, and joints.

Laboratory parameters: hypercalcemia, slight increase in HDL concentration; possible development of hyperphosphatemia (in patients with severe renal impairment).

From the CCC side: tachycardia, increased blood pressure.

From the digestive system: anorexia, vomiting, heartburn, abdominal pain, nausea, dryness of the oral mucosa, epigastric discomfort, constipation, diarrhea, slight increase in the activity of liver enzymes.

Interaction

In the treatment of osteoporosis, alfacalcidol can be prescribed in combination with estrogens and drugs that reduce bone resorption.

When alfacalcidol is co-administered with digitalis preparations, the risk of arrhythmia increases.

Inducers of microsomal liver enzymes (including phenytoin and phenobarbital ) reduce, and inhibitors – increase the concentration of alfacalcidol in plasma (it is possible to change its effectiveness).

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

Taking antacids increases the risk of hypermagnesemia and hyperaluminemia.

Toxic effects are weakened by retinol, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin. Calcitonin, derivatives of ethidronic and pamidronic acids, plicamycin, gallium nitrate and glucocorticosteroids reduce the effect. Alfacalcidol increases the absorption of phosphorous-containing drugs and the risk of hyperphosphatemia.

Concomitant use of alfacalcidol with calcium supplements, thiazide diuretics may cause hypercalcemia, due to increased absorption of calcium in the intestine, increased its reabsorption in the kidneys.

Other vitamin D medications and their derivatives should not be prescribed during alfacalcidol therapy due to possible additive interactions and an increased risk of hypercalcemia.

How to take, course of use and dosage

Inside, regardless of food intake, without chewing, with a sufficient amount of liquid, once a day.. The recommended daily dose of 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

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

  • For hypoparathyroidism

    From 2 to 4 mcg/day.

  • With osteodystrophy in CRF

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

  • For Fanconi syndrome and renal acidosis

    From 2 to 6 mcg/day.

  • For 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 up. 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 these doses, monitoring the level of calcium and phosphorus in the blood plasma once a week. The dose of the drug can be increased by 0.5 mcg / day until the biochemical parameters stabilize.

    Children over 3 years old

    • For rickets and osteomalacia associated with malnutrition or malabsorption

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

    • With osteodystrophy in CRF

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

    • For Fanconi syndrome and renal acidosis

      From 2 to 6 mcg/day.

For hypophosphatemic rickets and osteomalacia

Therapy begins with a dose of 1 mcg / 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, fatigue, general weakness, myalgia, bone pain.

Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, turbidity of urine, cardiac arrhythmia, 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 insufficiency up to death, growth disorders in children.

Treatment: the drug should be discontinued. In the early stages of 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 treatment 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 blood electrolytes, kidney function, and heart condition by electrocardiogram, especially in patients receiving digoxin.

Special instructions

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

When the ALP content in the blood plasma is normalized, it is necessary to reduce the dose of Alpha D 3-Teva, which will avoid the development of hypercalcemia. Hypercalcemia or hypercalciuria is corrected by discontinuing the drug and reducing calcium intake until the concentration of calcium in the blood plasma normalizes. As a rule, this period is 1 week. After normalization, therapy is continued, prescribing 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, taking even therapeutic doses can cause hypervitaminosis phenomena.

Children who receive vitamin D for a long time have an increased risk of developing growth retardation. For the prevention of hypovitaminosis D, a balanced diet is most preferable.

In the elderly, 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 D3, a decrease in the time of sun exposure, and an increase in the frequency of renal failure.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Alfacalcidol

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For children over 3 years of age, For adults as prescribed by a doctor, For children as prescribed by a doctor

Indications

Osteoporosis, Rickets, Malnutrition, Bone Fractures