Composition, form of production and packaging
Tablets 1 tab.
alfacalcidol 0.25 Ојg
- "- 0.5 mcg
- "- 1 Ојg
10 pieces. - packings of cellular contour (1) - bags of aluminum foil (1) - packs of cardboard.
10 pieces. - packings of cellular contour (10) - bags of aluminum foil (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Van Alpha, the regulator of phosphorus-calcium metabolism, has a D-vitamin and metabolic effect. The natural metabolite of 1-alpha 25-dihydroxyvitamin D3 (calcitriol) is the active form of vitamin D, formed from 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. Enhances the absorption of calcium ions (Ca 2+ ) and phosphate 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; increases 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, TC max in blood plasma 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 you to prescribe vitamin D deficiency in patients with renal insufficiency (the effect does not depend on the hydroxylation in the kidneys). T 1/2 - 19 days. It is excreted by the kidneys and with bile approximately in the same ratio. Cumulates.
INDICATIONS
The conditions associated with a violation of the metabolism of 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 callus;
- osteodystrophy in chronic renal failure (CRF);
- Hypoparathyroidism.
DOSING MODE
The drug is taken orally. The dosage of Van Alpha tablets should be selected individually according to the results of careful monitoring of the calcium content in the patient's blood plasma.
Adults :
- for rickets and osteomalacia caused by exogenous vitamin D deficiency and hypoparathyroidism, 1-4 mcg of adfacalcidol is prescribed per day;
- with osteodystrophy in chronic renal failure, 0.5-2 Ојg per day;
- with osteoporosis (including postmenopausal, senile, steroid) - 0.5-1 Ојg per day;
- with hypophosphatic rickets and osteomalacia - 4-20 mcg per day.
Begin treatment with minimal doses, controlling 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 biochemical parameters stabilize. 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.
- in case of osteoporosis, children of children's age are prescribed 0.01-0.03 Ојg / kg of body weight per day;
- with other diseases - 0.05-0.1 mcg / kg body weight per day;
- with renal osteodystrophy - 0.04-0.08 mkg / kg body weight per day.
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, and also the type of pathology. The maximum daily dose of the drug for children should not exceed that of adults.
SIDE EFFECT
Clinically important adverse reactions: ostria 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.
On the part of the gastrointestinal tract: nausea, a feeling of bloating, dyspepsia, constipation, decreased appetite, heartburn, a feeling of discomfort in the epigastrium, gastralgia, a metallic taste in the mouth, dry mouth, a slight increase in the activity of "liver" transaminases.
From the side of 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, tachycardia, arrhythmogenic effect.
From the musculoskeletal system: periarticular calcification (excessive bone formation), moderate pain in the bones, arthralgia.
On the part of metabolism: hypercalcemia, an increase in high-density lipoproteins, hyperphosphataemia (patients with severe renal dysfunction).
From the side of ophthalmology: congestion hyperemia.
Other: weight loss, polydipsia, nocturia, photophobia, hoarseness, kidney stones may be formed, allergic reactions (skin rash, itching, sensation of heat) are possible.
CONTRAINDICATIONS
- idiopathic hypercalcemia;
- nefrourolitiaz;
- the period of breastfeeding;
- Hyperphosphatemia (including renal osteodystrophy with hyperphosphatemia);
- hypermagnesia;
- hypercalcemia;
lactose intolerance;
- deficiency of lactase or glucose-galactose malabsorption;
- hypervitaminosis D;
- hypercalciuria;
- prolonged immobilization;
- thyrotoxicosis (probability of hypersensitivity);
- pulmonary tuberculosis (active form);
acute renal failure;
- children's age till 12 years;
- Hypersensitivity to colcalciferol.
With caution: prescribe the drug with organic heart lesions, atherosclerosis, acute and chronic liver and kidney diseases, nephrourolythiasis in history, gastrointestinal diseases (including gastric ulcer and duodenal ulcer), pregnancy, hypothyroidism, in old age (may contribute to development atherosclerosis), sarcoidosis or other graiulomatosis.
PREGNANCY AND LACTATION
Van Alpha tablets are allowed to be given to pregnant women (as well as for suspected pregnancy) only in those cases where 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.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in acute renal failure. Use with caution in acute and chronic kidney disease.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution in acute and chronic liver disease.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years. When prescribing this drug for children over 12 years of age, 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.
APPLICATION IN ELDERLY PATIENTS
Apply gently in the elderly (may contribute to the development of atherosclerosis).
SPECIAL INSTRUCTIONS
In order to avoid an overdose in patients during treatment, it is necessary to regularly check the level, calcium and phosphates 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 reaching C max and throughout the period - the concentration of Ca 2+ in blood plasma and urine is determined every 3-5 weeks, as well as the activity of alkaline phosphatase (in chronic renal failure - weekly monitoring). Pre-chronic renal failure requires a preliminary correction of hyperphosphataemia. 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 Ca 2+ 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 hypercalcaemia, taking Van Alpha tablets should be stopped immediately. If, after the drug is discontinued, the calcium level in the blood plasma drops to normal, you can resume taking the drug at 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, with the appointment and selection of a dose should be very careful.
Application for the treatment of 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 the drug is prescribed for patients with hyperphosphatemia, it is necessary to reduce the level of phosphorus in the blood plasma, using combined preparations that bind phosphorus.
OVERDOSE
Symptoms of vitamin D hypervitaminosis: early 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, clouding of urine (the appearance in the urine of hyaline-cylinders, proteinuria, leukocyturia) increased blood pressure, itchy skin, photosensitivity of the eyes, congestion hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gestalgia weight loss, and mood (up to the development of psychosis).
Symptoms of chronic intoxication with vitamin 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 when hypercalcamemia is associated with hyperphosphatemia), 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.
DRUG INTERACTION
Alfacalcidol increases the risk of heart rhythm disturbances on the background of cardiac glycosides (eg, digoxin).
Calcium preparations, phosphorus-containing medicines and preparations containing vitamin D increase the risk of side effects (including hypercalcemia). Inducers of microsomal liver enzymes (for example, phenytoin and phenobarbital) are reduced, and inhibitors increase the concentration of alfacalcidol in the blood plasma (possibly changing its effectiveness).
Calcitonin, derivatives of etidronic and pamidronic acids, plikamycin, gallium nitrate and glucocorticosteroids reduce the effect of alfacalcidol.
The simultaneous use of drugs containing magnesium (for example, magnesium oxide, magnesium carbonate) increases the risk of hypermagnesemia.
Mineral oils, protein-rich foods, colestyramine, colestipol, sucralfate and antacids reduce the absorption of alfacalcidol.
Simultaneous hemodialysis or the use of antacids increase the risk of hypermagnesemia and hyperaluminia; Thiazide diuretics - hypercalcemia. In the treatment of osteoporosis can be prescribed in combination with estrogens and other drugs that reduce bone resorption.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
List B. In a dry, sheltered from the sung place, at a temperature of not higher than 30 В° РЎ. Store in inaccessible to children. Shelf life - 3 years.
