Oksidevit® (international nonproprietary name alfacalcidol) is an active form of vitamin D. The drug is used to correct disorders of phosphorus-calcium metabolism. Oksidevit is included in the List of vital and essential drugs.
Before use, consult a specialist.
Nati offline pharmacies where you can buy the drug can be found here.
In Russia, the technology for the synthesis of alfacalcidol - 1α-hydroxyvitamin D3 was developed in 1978 at the All-Union Scientific Research Vitamin Institute. In 1987, after pharmacological and clinical trials, the drug was approved for medical use under the trade name Oksidevit ®.
Since 1998, Oksidevit ® has been produced by ZAO NPK ECHO with the direct participation of the authors of the drug.
Release form, dosage
Drops for oral administration 9 mcg/ml, 5 ml, dark glass bottles, sealed with caps with droppers (1), cardboard packs.
What is Oksidevit®
In the early 70s, it was established that the physiological activity of vitamin D is associated with its transformation in the body into 1α,25-dihydroxyvitamin D3 - calcitriol. Calcitriol is the active form of vitamin D that regulates phosphorus-calcium metabolism. It became clear that the causes of a number of diseases in which there is a violation of phosphorus-calcium metabolism, such as osteoporosis, renal osteodystrophy, vitamin D-dependent rickets, phosphate diabetes, hypoparathyroidism, lie in the insufficient efficiency of converting vitamin D entering the body into its active, active form. form. The most important step in this transformation is 1α-hydroxylation, which occurs in the kidneys. However, disturbances of phosphorus-calcium metabolism often occur in old age or in people with diseased kidneys in whom the process of renal hydroxylation is impaired. At the same time, it was found that 1α-hydroxyvitamin D3 entering the body is quickly converted into its active form - calcitriol . This process occurs even in people with impaired hydroxylation of vitamin D in the kidneys, which makes it possible to use 1α-hydroxyvitamin D3 as a drug to correct disorders of phosphorus-calcium metabolism. 1α-Hydroxyvitamin D3 received the international nonproprietary name alfacalcidol . The drug was released by a number of foreign companies under the trade names Van Alpha, Alpha D3, 1-alpha, Etalfa, etc.
Oksidevit
Trade name: Oxidevit International name: Alfacalcidol
Release form: oral solution in oil 0.0009% (dark glass dropper bottle, dark glass bottle) 5, 10 ml
Ingredients: alfacalcidol 9 mg - 1 l
Pharmacological group: vitamin - calcium-phosphorus metabolism regulator
Pharmacological group according to ATK: A11CC03 (Alfacalcidol)
Pharmacological action: D-vitamin, metabolic, antirachitic, regulating phosphorus-calcium metabolism,
Indications: Hypo- and avitaminosis of vitamin D (prevention and treatment), as well as conditions of the body’s increased need for vitamin D: osteomalacia, osteoporosis, osteopathy (including after kidney transplantation, against the background of renal failure), poor and unbalanced nutrition ( including parenteral, vegetarian diet), malabsorption, insufficient insolation, hypocalcemia due to hypoparathyroidism, familial hypophosphatemia (vitamin D-resistant rickets), alcoholism, liver failure, liver cirrhosis, Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, late rickets and adiposogenital dystrophy), obstructive jaundice, gastrointestinal diseases (gluten enteropathy, persistent diarrhea, tropical sprue, Crohn's disease), rapid weight loss, pregnancy (especially with nicotine and drug addiction, multiple pregnancy), lactation period, breastfed newborns, with insufficient insolation, taking barbiturates, cholestyramine, colestipol, mineral oils, anticonvulsants (incl. phenytoin and primidone).
Dosage regimen: Inside. Adults: initial dose - 1 mcg/day, can be increased by 0.5 mcg every 2-4 weeks to 2 (in rare cases up to 3) mcg/day, maintenance dose - 0.25-1 mcg/day; children - 0.25 mcg/day.
Alpha D3-Teva: orally, for adults with osteomalacia caused by exogenous vitamin D deficiency, 1-3 mcg/day is prescribed, for osteodystrophy with chronic renal failure - 0.07-2 mcg, for Fanconi syndrome - 2-6 mcg, for hypophosphatemic rickets and osteomalacia - 4-20 mcg, for postmenopausal, senile, steroid osteoporosis - 0.5-1 mcg. Treatment is started with minimal doses, monitoring the content of Ca2+ and phosphorus in the plasma once a week; if necessary, the dose is increased by 0.25 or 0.5 mcg/day until biochemical parameters stabilize. Once the optimal effective dose is achieved, it is recommended to monitor plasma Ca2+ levels every 3-5 weeks. Children weighing less than 20 kg are prescribed 0.01-0.05 mcg/kg/day, 20 kg and above - 1 mcg/day, for renal osteodystrophy - 0.04-0.08 mcg/kg/day.
Oksidevit: orally (capsules or 0.0009% solution in oil), regardless of food intake (1 drop = 0.25 mcg). For children with rickets-like diseases - 0.5-3 mcg/day (2-12 drops), depending on age and body weight, for 2-3 months, if necessary - up to 1 year.
For rickets - 1 mcg/day daily for 10 days, 3 courses of treatment are carried out with a break of 2 weeks. For children on hemodialysis, in order to eliminate osteodystrophy - 1 mcg/day, with simultaneous use of vitamin D2 2000 IU or dioxivit - 20-40 mcg/day daily for a long time. Adults on hemodialysis, 1-2 mcg/day (4-8 drops) daily or every other day, followed by a dose reduction to 0.5 mcg, depending on the normalization of Ca2+ in the blood and alkaline phosphatase activity, treatment courses - 2-3 months , it is recommended to repeat 2-3 times a year.
After kidney transplantation for prophylactic purposes - 0.25-1 mcg/day daily or every other day. For bone pathologies of various origins - 0.5-3 mcg/day for a long time (from 2-3 to 12 months or more).
For osteomalacia associated with impaired absorption of Ca2+, phosphates or vitamin D in the intestine - 0.25-1.5 mcg/day.
Contraindications: Hypersensitivity, hypercalcemia, hypervitaminosis D, renal osteodystrophy with hyperphosphatemia.
Side effects: Allergic reactions.
Overdose. Symptoms of vitamin D hypervitaminosis: early (due to hypercalcemia) - constipation or diarrhea, dry oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, unusual fatigue, general weakness, hypercalcemia , hypercalciuria, late - bone pain, urine turbidity (appearance of hyaline casts in the urine, proteinuria, leukocyturia), increased blood pressure, skin itching, photosensitivity of the eyes, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss , rarely - changes in psyche and mood (up to the development of psychosis). Symptoms of chronic vitamin D intoxication: calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and cardiovascular failure up to death (these effects most often occur when hyperphosphatemia is combined with hypercalcemia), impaired growth in children. Treatment: discontinuation of the drug until the Ca2+ content in the plasma is normalized (usually for 1 week), then treatment can be resumed with half of the last dose used, in the early stages of acute overdose - gastric lavage, administration of mineral oil, which helps reduce absorption and increase excretion in feces . In severe cases - intravenous administration of 0.9% NaCl solution, loop diuretics, corticosteroids.
Pharmacodynamics: A remedy that replenishes vitamin D3 deficiency. Regulator of phosphorus-calcium metabolism. A natural metabolite of 1 alpha, 25-dihydroxyvitamin D3 (calcitriol), the active form of vitamin D produced from vitamin D3 in the kidneys. Affects the nuclei of target cells and stimulates the transcription of DNA and RNA in the intestinal epithelium, bone tissue, renal parenchyma and skeletal muscles. Enhances the absorption of Ca2+ and phosphates in the intestine and their reabsorption in the proximal tubules of the kidneys, increases bone mineralization 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. Restores a positive calcium balance in the treatment of calcium malabsorption syndrome, reduces the intensity of bone resorption and the incidence of fractures. During a course of treatment, it reduces bone and muscle pain associated with impaired phosphorus-calcium metabolism and improves coordination of movements. Duration of action - up to 48 hours.
Pharmacokinetics: Absorption - high, TCmax - 8-18 hours. In the blood it binds to specific alpha globulins. Metabolized in the liver to form the active metabolite calcitriol (1.25-dihydroxycolecalciferol), a smaller part is metabolized in bone tissue. Unlike natural vitamin D, it is not metabolized in the kidneys, which allows it to be prescribed for vitamin D deficiency in patients with renal failure (the effect does not depend on hydroxylation in the kidneys). T1/2 - 19 days. It is excreted by the kidneys and bile (in approximately the same ratio). Cumulates.
Special instructions: Therapy must be carried out under constant monitoring of the concentration of Ca2+ and phosphates in the blood (at the beginning of treatment - once a week, when Cmax is reached and throughout the entire period - the concentration of Ca2+ in plasma and urine every 3-5 weeks), as well as activity Alkaline phosphatase (for chronic renal failure - weekly monitoring). In case of chronic renal failure, preliminary correction of hyperphosphatemia is required. When normalizing the level of alkaline phosphatase in plasma, an appropriate dose reduction is necessary (to avoid the development of hypercalcemia). Hypercalcemia and hypercalciuria are corrected by discontinuing treatment and reducing Ca2+ intake (usually after 1 week). After normalization, therapy is continued, prescribing 1/2 of the last dose used. It should not be prescribed simultaneously with other vitamin D drugs and its derivatives. Use during pregnancy and lactation is possible if the expected benefit to the mother outweighs the potential risk to the fetus. It should be borne in mind that sensitivity to vitamin D varies from patient to patient, and in some patients taking even therapeutic doses can cause symptoms of hypervitaminosis. Newborns' sensitivity to vitamin D varies, and some may be sensitive to even very low doses. Children who receive vitamin D over a long period of time have an increased risk of stunted growth. To prevent hypovitaminosis D, a balanced diet is most preferable.
Breastfed newborns, especially those born to mothers with dark skin and/or insufficient sun exposure, are at high risk of developing vitamin D deficiency. Animal studies have shown that calcitriol, at doses 4 to 15 times higher than recommended human doses, has a teratogenic effect. Maternal hypercalcemia (associated with prolonged overdose of vitamin D during pregnancy) can cause increased sensitivity to vitamin D in the fetus, suppression of parathyroid function, specific elf-like appearance syndrome, mental retardation, and aortic stenosis. 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 provitamin D3, a decrease in sun exposure, and an increase in the incidence of renal failure.
Carefully. Atherosclerosis, sarcoidosis or other granulomatosis, CHF, history of nephrourolithiasis, hyperphosphatemia, chronic renal failure, pregnancy, lactation, childhood. Category of action on the fetus. C
Interaction: Alfacalcidol increases the risk of developing heart rhythm disturbances due to cardiac glycosides. Ca2+ and phosphorus-containing drugs, as well as other drugs containing vitamin D, increase the risk of side effects (including hypercalcemia). Inducers of microsomal liver enzymes (for example, phenytoin and phenobarbital) reduce, and inhibitors increase, the concentration of alfacalcidol in plasma (possibly changing its effectiveness). Mineral oils, albumin-rich foods, cholestyramine, colistepol, sucralfate and antacids reduce the absorption of alfacalcidol. Taking antacids increases the risk of developing hypermagnesemia and hyperaluminemia; Ca2+ drugs and thiazide diuretics increase the risk of hypercalcemia. In the treatment of osteoporosis, it can be prescribed in combination with estrogens and other drugs that reduce bone resorption. The toxic effect is weakened by vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin. Calcitonin, derivatives of etidronic and pamidronic acids, plicamycin, gallium nitrate and corticosteroids reduce the effect. Increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.
Storage conditions: List B
Drug registration number: P No. 001326/02
Date of registration (re-registration) of the drug: 07/15/2005
Advantages of the drug:
When choosing a medicine, undoubtedly, a very important indicator for the consumer is the cost of treatment with a particular drug. In the case of Oxidevit, this figure is 5-8 times lower than when using the same doses of foreign-made alfacalcidol preparations. So, 1 bottle of Oxidevit (5 ml) is equivalent in the doses of medicine it contains to 5 packages (5x30 capsules) of the drug Alpha D 3 (Teva).
In addition to lower cost, an important advantage of Oxydevit is the absence of preservatives and gelatin in the drug, which can cause allergic reactions.
Oxidevit®
A necessary condition for optimal effectiveness of Oxidevit® therapy is a sufficient, but not excessive intake of calcium from food and medications from the beginning of treatment (for adults - about 800 mg, but not more than 1000 mg per day). However, during treatment with Oxidevit®, drugs and nutritional supplements containing calcium, vitamin D and parathyroid hormone should be used with caution due to the risk of hypercalcemia.
Patients with a tendency to hypercalcemia should be prescribed calcium supplements only in small doses or even discontinue them.
The use of antacids or laxatives containing magnesium should also be monitored.
During the course of treatment with the drug, it is necessary to monitor the content of calcium, phosphorus, magnesium and alkaline phosphatase in the blood serum, as well as calcium and phosphates in daily urine at least once a month in the initial period of treatment and at least once every 3 months after achieving stabilization of the condition patient.
Calcium levels should be monitored especially carefully in patients with kidney and heart diseases, since prolonged hypercalcemia can lead to further deterioration in the functional state of these organs.
Blood for calcium determination should be taken without using a tourniquet.
In order to avoid the development of hypercalcemia, when biochemical signs of normalization of bone formation are achieved (normalization of alkaline phosphatase in the blood plasma), the dose of the drug is reduced to a maintenance dose.
Hypercalcemia or hypercalciuria can be corrected by discontinuing the drug and reducing calcium intake until plasma calcium concentrations normalize. Typically this period is 1 week. Therapy can then be continued, starting with half the last dose used.
You should also evaluate your daily dietary calcium intake and make dietary adjustments if necessary.
If the level of total serum calcium is 0.25 mmol/l or more higher than normal (2.25-2.75 mmol/l), or if the product of total serum calcium by inorganic phosphorus of blood serum [Total (mmol /l) x Rneorg. (mmol/l)] exceeds 6, and if serum creatinine exceeds 0.12 mmol/l, Oxidevit® should be stopped immediately until normocalemia is restored.
Patients with normal renal function taking Oxidevit® should avoid dehydration by ensuring adequate fluid intake.
