Active substanceAlfacalcidolAlfacalcidol
Dosage form: & nbsppills
Composition:

Composition per 1 tablet

active substance: alfacalcidol 0.25 μg 0.5 μg 1 μg

Excipients: lactose anhydrous, povidone K 30, propyl gallate, magnesium stearate.

Description:

Round white tablets without a smell, on one side an inscription - "TJN ONE", on the reverse side - 0.25 or 0.5, or 1.0.

Pharmacotherapeutic group:Vitamin - calcium-phosphorus exchange regulator
ATX: & nbsp

A.11.C.C.03   Alfacalcidol

Pharmacodynamics:

VAN-ALPHA® regulator of phosphoric-calcium exchange, renders D- Vitamin and metabolic action.Natural metabolite 1 alpha, 25-dihydroxyvitamin D3 (calcitriol) - an active form of vitamin D, formed from a vitamin D3 in the kidneys. Affects the nuclei of target cells and stimulates the transcription of DNA and RNA in intestinal epithelium, bone tissue, renal parenchyma and skeletal muscles. It enhances the absorption of calcium ions (Ca2 +) and phosphates in the intestine, increases the mineralization of bones by stimulating the synthesis of osteocalcin in bone tissue, reduces the activity of alkaline phosphatase and the content of parathyroid hormone in the blood; normalizes the functions of muscle tissue, the growth and differentiation of cells of various types; enhances cellular and humoral immunity. It restores a positive calcium balance in the treatment of calcium malabsorption syndrome, reduces the intensity of bone resorption and the frequency of fracture development.

With the course treatment reduces bone and muscle pain associated with the violation of phosphorus-calcium metabolism, improves coordination of movements. Duration of action - up to 48 hours.

Pharmacokinetics:

Absorption is high, the time to reach the maximum concentration in the blood plasma (TSmah) is from 8 to 18 hours.In the blood it binds to specific alpha globulins. Metabolised in the liver with the formation of an active metabolite of calcitriol (1,25-dihydroxycolecalciferol); The smaller part is metabolized in bone tissue. Unlike natural vitamin D, It is not metabolized in the kidneys, which allows prescribing with vitamin deficiency D in patients with renal insufficiency (the effect does not depend on the hydroxylation in the kidneys). The half-life (T1 / 2) is 19 days. It is excreted by the kidneys and with bile approximately in the same ratio. Cumulates.

Indications:

Conditions associated with a violation of the metabolism of the vitamin D: prevention and treatment of osteopathy of different genesis: osteomalacia, osteoporosis, after surgical interventions for "false" joints with the phenomena of delayed fracture consolidation, to stimulate the formation of bone Corn; osteodystrophy in chronic renal failure (CRF); Hypoparathyroidism.

Contraindications:

Idiopathic hypercalcemia, increased sensitivity to colcalciferol, nephrourolythiasis, the period of breastfeeding, hyperphosphatemia (including renal osteodystrophy with hyperphosphatemia), hypermagnesia,hypercalcemia; lactose intolerance, lactase deficiency or glucose-galactose malabsorption. Hypervitaminosis D, hypercalciuria, prolonged immobilization, thyrotoxicosis (probability of hypersensitivity), pulmonary tuberculosis (active form), acute renal failure, children under 12 years of age.

Carefully:

Carefully prescribe the drug with organic heart lesions, atherosclerosis, acute and chronic liver and kidney disease, nephrourolythiasis in history, diseases of the gastrointestinal tract (including gastric ulcer and duodenal ulcer), pregnancy, hypothyroidism, in the elderly (can promote the development of atherosclerosis), sarcoidosis or other granulomatosis.

Pregnancy and lactation:

Tablets of VAN-ALPHA® are allowed to be given to pregnant women (and also if pregnancy is suspected) only in those cases when the expected therapeutic effect exceeds the possible risk for the fetus associated with taking the drug.

During the period of breastfeeding, it is not recommended to take this medication.

If the purpose of this drug is justified by important medical indications, then during treatment breastfeeding should be discontinued.

Dosing and Administration:

The drug is taken orally.The dosage of VAN-ALPHA® tablets should be selected individually based on the results of careful monitoring of the calcium content in the patient's blood plasma.

Adults:

- with rickets and osteomalacia, caused by exogenous vitamin deficiency D and for hypoparathyroidism prescribe 1 -4 mcg of alfacalcidol per day;

- at osteodystrophy with KHPN-0.5-2 mcg per day;

- at osteoporosis (including post-mepopausal, senile, steroid) - 0.5-1 μg per day;

- at hypophosphatitis rickets and osteomalacia - 4-20 mcg per day.

Begin treatment with minimal doses, monitoring once a week the content of calcium and phosphorus in the blood plasma, if necessary, increase the dose to 0.25 or 0.5 mcg / day until the stabilization of biochemical indicators. When the optimal effective dose is reached, it is recommended to monitor the concentration of calcium in the blood plasma every 3-5 weeks.

Children:

The drug is used in children from 12 years.

- at osteoporosis patients of children's age are prescribed 0.01-0.03 μg / kg of body weight per day;

- at other diseases - 0,05-0,1 mkg / kg of body weight per day;

- at renal osteodystrophy - 0,04-0,08 mkg / kg of body weight per day.

The dosage of the drug should be selected taking into account the nature of the disease, the age of the patient, the specific symptoms and signs of the disease,as well as the type of pathology. The maximum daily dose of the drug for children should not exceed that of adults.

Side effects:

Clinically important adverse reactions:

Acute renal failure, impaired liver function.

If any of the following adverse reactions are found, appropriate measures should be taken, such as a reduction in dosage or a break in taking the drug.

From the gastrointestinal tract:

Nausea, bloating, dyspepsia, constipation, decreased appetite, heartburn, epigastric discomfort, gastralgia, metallic taste in the mouth, dry mouth, slight increase in the activity of "liver" transaminases.

From the nervous system:

Headaches, insomnia, irritability, weakness, dizziness, drowsiness, memory problems, tinnitus, hearing loss, back pain, stiff shoulder stiffness, lower extremity cramps, chest pains, fatigue, dysphoria.

From the cardiovascular system:

Increased blood pressure (BP), tachycardia, arrhythmogenic effect.

From the musculoskeletal system:

Periarticular calcification (excessive bone formation), moderate pain in the bones, arthralgia.

From the side of metabolism:

Hypercalcemia, an increase in high-density lipoproteins, hyperphosphataemia (patients with severe renal dysfunction).

From ophthalmology:

Hyperemia of the conjunctiva.

Other: weight loss, polydipsia, nocturia, photophobia, hoarseness, kidney stones may be formed, allergic reactions (skin rash, itching, sensation of heat) are possible.

Overdose:

Symptoms of vitamin hypervitaminosis D: early (due to hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, unusual fatigue, general weakness, hypercalcemia, hypercalciuria; late pain in the bones, turbidity of urine (the appearance of hyaline cylinders, proteinuria, leukocyturia in the urine) increased blood pressure, itchy skin, photosensitivity of the eyes, congestion hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss, rarely - change mentality and mood (up to the development of psychosis).

Symptoms of chronic vitamin intoxication D: calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and cardiovascular insufficiency up to the fatal outcome (these effects occur most often with hypercalcemia of hyperphosphataemia), growth disorders in children.

Treatment: cancellation of the drug before the normalization of calcium in the blood plasma (usually for 1 week); then treatment can be resumed at half the last dose applied; in the early periods of acute overdose - gastric lavage, the appointment of a mineral oil, which helps to reduce absorption and increase excretion with calves; in severe cases, intravenous administration of 0.9% sodium chloride solution may be required, in some cases - the appointment of loop diuretics, glucocorticosteroids.

Interaction:

Alfacalcidol increases the risk of heart rhythm disturbances on the background of cardiac glycosides (for example, digoxin).

Calcium preparations, phosphorus-containing medicines and preparations containing vitamin D, increase the risk of side effects (including hypercalcemia).Inducers of microsomal liver enzymes (eg, phenytoin and phenobarbital) reduce, and inhibitors increase the concentration of alfacalcidol in the blood plasma (it is possible to change its effectiveness).

Calcitonin, derivatives of etidronic and pamidronic acids, plikamycin, gallium nitrate and glucocorticosteroids reduce the effect of alfacalcidol.

Simultaneous use of drugs containing magnesium (eg magnesium oxide, magnesium carbonate) increases the risk of hypermagnesemia.

Mineral oils, protein-rich foods, colestramine, Colestipol, sucralfate and antacids reduce the absorption of alfacalcidol.

Simultaneous hemodialysis or the use of antacids increase the risk of hypermagnesia and hyperammonemia; Thiazide diuretics - hypercalcemia. In the treatment of osteoporosis can be prescribed in combination with estrogens and other drugs that reduce bone resorption.

Special instructions:

In order to avoid an overdose in patients during treatment, it is necessary to regularly check the level of calcium and phosphate in the blood plasma, and the dose of the drug should be selected in such a way that the level of calcium in the blood plasma does not exceed the permissible level.

At the beginning of treatment - once a week, when the maximum concentration in the blood plasma (Cmax) and throughout the period - the concentration of Ca2 + in the blood plasma and urine is determined every 3-5 weeks, as well as the activity of alkaline phosphatase (with chronic renal failure weekly monitoring). In chronic renal failure, a preliminary correction of hyperphosphataemia is required.

With the normalization of alkaline phosphatase in blood plasma, an appropriate dose reduction is necessary (to avoid the development of hypercalcemia). Hypercalcemia and hypercalciuria are corrected by cancellation of treatment and a decrease in Ca2 + intake (usually after 1 week). After the normalization of the calcium level, therapy is continued, appointing half of the last dose applied.

In the case of hypercalcemia, taking VAN-ALPHA® tablets should be stopped immediately. After the drug has been discontinued, the level of calcium in the blood plasma will decrease to the normal level, you can resume taking the drug with a lower dosage.

Application for the treatment of elderly patients

Since in the elderly, usually there is a decrease in physiological processes in the body,At appointment and selection of a dose it is necessary to show special care.

Treatment for patients - children

When prescribing this drug for children, it should start with low doses and gradually increase the dosage under the control of calcium levels in the blood plasma, as well as the ratio of calcium and creatinine in the urine. This drug should be used with caution in order to avoid an overdose.

Additional Cautions

When prescribing the drug for patients with hyperphosphatemia, it is necessary to reduce the level of phosphorus in the blood plasma, using combined preparations that bind phosphorus.

Effect on the ability to drive transp. cf. and fur:
Form release / dosage:

Tablets 0.25 μg, 0.5 μg, 1 μg.

Packaging:10 tablets per blister of PVC film and aluminum foil; 1 blister or 10 blisters are sealed in an aluminum foil bag and, together with the instruction for use, are placed in a cardboard box.
Storage conditions:

List B.

In a dry, protected from light place, at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date of the drug.

Terms of leave from pharmacies:On prescription
Registration number:P N009745 / 01
Date of registration:30.06.2009
Expiration Date:Unlimited
Date of cancellation:2017-07-06
The owner of the registration certificate:Teijin Pharma LimitedTeijin Pharma Limited Japan
Manufacturer: & nbsp
Representation: & nbspISKRA SANGIO LLCISKRA SANGIO LLCRussia
Information update date: & nbsp06.07.2017
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