Alpha D3-Teva capsules 0.5mcg, No. 60

• Osteoporosis (including postmenopausal, senile, steroid);

• osteodystrophy in chronic renal failure;

• hypo-, pseudohypo- and hyperparathyroidism (with damage to the bones);

• rickets and osteomalacia associated with malnutrition or malabsorption;

• hypophosphatemic vitamin D-resistant and pseudo-deficiency (vitamin D-dependent) rickets and osteomalacia;

• Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and adiposogenital dystrophy);

• renal acidosis.

Assign inside.

The recommended daily dose of the drug can be taken immediately in 1 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 absorption: 1 to 3 mcg / day for at least 2-3 months. With hypoparathyroidism: from 1 to 4 mcg / day.

With osteodystrophy in chronic renal failure: from 0.5 to 2 ?g / 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 ?g / day. The maximum daily dose can be up to 20 mcg. If it is necessary to prescribe alfacalcidol in high doses, consideration should be given to using another dosage form of Alfa D3-TevaЃ with a higher dosage or another dosage form of alfacalcidol.

With osteoporosis (including postmenopausal, senile, steroid): from 0.5 to 1 ?g / day. It is recommended to start treatment with a minimum dose, monitoring once a week the content of calcium and phosphorus in the blood plasma. The dose can be increased by 0.5 ?g / day until the biochemical parameters stabilize.

Children over 3 years old

For rickets and osteomalacia associated with 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 ?g / 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 ?g / day.

Capsules

1 caps.

alfacalcidol

Excipients: anhydrous citric acid, propyl gallate, vitamin E (d, l -? - tocopherol), absolute ethanol, peanut oil.

• Hypercalcemia;

• hyperphosphatemia (with the exception of hyperphosphatemia in hyperparathyroidism);

• hypermagnesemia;

• hypervitaminosis D;

• pregnancy;

• lactation period (breastfeeding);

• children under 3 years old;

• hypersensitivity to alfacalcidol and other components of the drug.

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

pharmachologic effect

Vitamin, regulator of calcium-phosphorus metabolism.

Alfacalcidol (1?-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.

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.

Elderly patients with endocrine-immune dysfunction, incl. 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 system), which is accompanied by an increased risk of falls and related injuries and fractures. A number of studies have shown a significant decrease in the incidence of falls in elderly patients with the use of alfacalcidol.

Alfacalcidol stimulates the regeneration of muscle fibers, which restores lost muscle tone.

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 pathology, old age).

Withdrawal

It is excreted by the kidneys and through the intestines with bile in approximately equal proportions.

Side effect

From the digestive system: anorexia, vomiting, heartburn, abdominal pain, nausea, dryness of the oral mucosa, discomfort in the epigastric region, constipation, diarrhea; rarely - a slight increase in the activity of 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.

From the side of metabolism: hypercalcemia, a slight increase in the concentration of HDL cholesterol, in patients with severe renal dysfunction, hyperphosphatemia may develop.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and during breastfeeding.

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.

Application for impaired renal function

The drug should be prescribed with caution in case of renal failure.

Application in children

Contraindicated in children under 3 years of age.

special instructions

During the use of the drug Alpha D3-TevaЃ in children and in patients with chronic renal failure, it is necessary to regularly monitor the content of calcium and phosphates (at the beginning of treatment - once a week, upon reaching Cmax in the blood plasma and during the entire period of treatment - every 3 -5 weeks), as well as the activity of alkaline phosphatase (in chronic renal failure - weekly control) in the blood plasma. In chronic renal failure, preliminary correction of hyperphosphatemia is required.

When normal ALP activity in blood plasma is reached, the dose of Alpha D3-TevaЃ must be reduced, which will avoid the development of hypercalcemia.

At the beginning of treatment with Alpha D3-TevaЃ, it is recommended to measure the calcium content, especially in conditions without significant bone damage, for example, with hypoparathyroidism and if the calcium content in the blood plasma is already increased, as well as at later stages of treatment - if there are signs of recovery bone structure.

The risk of developing hypercalcemia is determined by factors such as the degree of bone demineralization, the functional capacity of the kidneys, and the dose of the drug.

Hypercalcemia or hypercalciuria is corrected by lowering the dose of Alfa D3-TevaЃ and reducing calcium intake until its content in blood plasma normalizes. Typically, this period is 1 week. After normalization, therapy is continued using half of the last dose used.

With the development of hypercalcemia or a persistent increase in the content of calcium-phosphate compounds, which goes beyond the clinical norm, the drug should be immediately discontinued, at least until these indicators are normalized (usually within a week), then the use of the drug can be resumed at a dose , which is half of the previous one.

Patients with severe bone damage (as opposed to patients with renal insufficiency) can tolerate higher doses of the drug without signs of hypercalcemia. The absence of a rapid increase in the calcium content in the blood plasma in patients with osteomalacia does not always mean that the dose of the drug should be increased, because calcium can penetrate into demineralized bone due to its increased absorption in the intestine.

It is necessary to prevent the development of prolonged hypercalcemia, especially in chronic renal failure, focusing on indicators such as calcium content in serum and urine, alkaline phosphatase activity, parathyroid hormone concentration, X-ray and histological data.

To prevent the development of hyperphosphatemia in patients with renal bone disease, alfacalcidol can be used together with phosphate binders.

It should be borne in mind that the sensitivity to vitamin D varies from patient to patient, and sometimes the use of even therapeutic doses may be accompanied by symptoms of 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 D3, a decrease in the time of sun exposure, and an increase in the incidence of renal failure.

The excipients of the preparation include peanut oil. The drug is contraindicated in patients with an allergic reaction to peanut butter and soy.

Influence on the ability to drive vehicles and use mechanisms

Care should be taken when driving vehicles and mechanisms that require an increased concentration of attention and speed of psychomotor reactions, since when using the drug Alpha D3-TevaЃ, dizziness and drowsiness may develop.

Overdose

Early symptoms of hypervitaminosis D (due to hypercalcemia): diarrhea, constipation, nausea, vomiting, dryness of the oral mucosa, anorexia, metallic taste in the mouth, hypercalciuria, polyuria, polydipsia, pollakiuria / nocturia, headache, fatigue, general weakness, bone pain.

Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, clouding of urine, heart rhythm disturbances, pruritus, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia, psychotic disorders.

Symptoms of chronic hypervitaminosis D: 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 discontinued. In the early stages of acute overdose - gastric lavage, the use of mineral oil (vaseline), which helps to reduce absorption and increase excretion through the intestine. In severe cases, supportive therapeutic measures may be required - hydration is performed with the introduction of infusion saline solutions (forced diuresis), in some cases - the use of corticosteroids, loop diuretics, bisphosphonates, calcitonin, 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 ECG), especially in patients receiving digoxin or other cardiac glycosides.

Drug interactions

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

With the simultaneous use of alfacalcidol with cardiac glycosides, the risk of developing cardiac arrhythmias increases.

Inducers of microsomal liver enzymes (including phenytoin and phenobarbital) decrease, and inhibitors increase the concentration of alfacalcidol in blood plasma (a change in its effectiveness is possible).

The absorption of alfacalcidol decreases when it is used simultaneously with mineral oil (for a long time), cholestyramine, colestipol, sucralfate, antacids, albumin-based preparations. To reduce the likelihood of interaction, alfacalcidol should be used 1 hour before or 4-6 hours after taking the above drugs.

The simultaneous use of magnesium-containing antacids and alfacalcidol can cause an increase in the content of magnesium in the blood plasma, and aluminum-containing antacids - aluminum in the blood plasma, especially in chronic renal failure.

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

The simultaneous use of alfacalcidol with calcium preparations, thiazide diuretics may increase the risk of hypercalcemia.

Against the background of therapy with alfacalcidol, other drugs containing vitamin D and its derivatives should not be used because of the possible additive interaction and an increased risk of hypercalcemia.