Devit 50000 tablets p/o 50000ME No. 8×1

Name:
Devit 50000.
Description:
Reddish-brown oval film-coated tablets. The main active ingredient is Vitamin D. Release form Tablets. Dosage 50 thousand IU. Pharmacological action Vitamin-calcium-phosphorus metabolism regulator. Pharmacological groupVitamins. Vitamin D and analogues. Pharmacological properties Pharmacodynamics Vitamin D3 regulates the metabolism of calcium and phosphorus in the body, accelerates the absorption of calcium in the intestines, improves the reabsorption of calcium and phosphorus in the kidneys, maintains the required level of these elements in the blood, promotes the formation of the bone skeleton, as well as maintaining the structure of bones. The concentration of calcium ions in the blood determines the maintenance of muscle tone of the skeletal muscles, myocardial function, promotes the conduction of nervous excitation, regulates the process of blood coagulation. Also, vitamin D3 is necessary for the normal functioning of the parathyroid glands. As we age, sun exposure decreases and the skin’s ability to synthesize vitamin D3 decreases. As kidney function declines, levels of the active vitamin D metabolite 1,25(OH)2D produced in the kidneys are reduced, contributing to the widespread prevalence of vitamin D deficiency among the elderly. Since vitamin D is essential for adequate calcium absorption and normal bone metabolism, chronic deficiency causes secondary hyperparathyroidism and, as a consequence, activation of bone metabolism and rapid bone loss. Vitamin D supplementation, especially when combined with calcium supplementation, has been shown to slow bone loss and reduce the incidence of fractures. Vitamin D therapy is a mandatory component of osteoporosis prevention along with calcium intake. In addition, vitamin D intake is a mandatory component of the complex treatment of established osteoporosis. Pharmacokinetics The pharmacokinetics of vitamin D has been well studied. Vitamin D is well absorbed from the gastrointestinal tract in the presence of bile. It is hydroxylated in the liver to form 25-hydroxycholecalciferol and then further hydroxylated in the kidneys to form the active metabolite 1,25-hydroxycholecalciferol (calcitriol). These metabolites circulate in the blood by binding to a specific alpha globulin. Vitamin D and its metabolites are excreted from the body, mainly with bile and feces. Features of the pharmacokinetics of the drug in some groups of patients In patients with impaired renal function, a 57% decrease in the rate of metabolic clearance was observed compared with that in healthy volunteers. In volunteers with malabsorption syndrome, there was a decrease in absorption and an acceleration in the excretion of vitamin D. Obese volunteers are less able to maintain vitamin D levels in the body when exposed to the sun, and therefore higher doses are required. Indications for use Treatment of vitamin D deficiency. Prevention of vitamin D deficiency in high-risk patients. Route of administration and doses Treatment of vitamin D deficiency: 50,000 IU/week (1 tablet) for 7 weeks, followed by maintenance treatment (equivalent to 1400-2000 IU/day), for example, 1 tablet per month, if necessary. Maintenance therapy: carried out under the control of the concentration of 25-(OH) D in the blood over the next 3-4 months to confirm the achievement of the target level. The dose is adjusted individually depending on the severity of vitamin D deficiency and response to treatment, for example: Osteoporosis: for adjunctive therapy of osteoporosis at a daily dose of 800-1000 IU, or the corresponding total weekly dose of 7000 IU, or an alternative monthly dose of 50,000 IU of vitamin D. For elderly patients, who are particularly at risk of falls and fractures, a dose equivalent to 2000 IU of vitamin D per day is recommended. Patients should receive additional calcium if dietary intake is inadequate. Vitamin D deficiency (serum levels of 25-(OH)D < 25 nmol/l or < 10 ng/ml) in adults and elderly patients: at the rate of 800-4000 IU per day for 12 weeks. Vitamin D deficiency (serum 25-(OH)D levels 25–50 nmol/L or 10–20 ng/mL) in adults and elderly patients, long-term maintenance treatment after deficiency treatment in adults and the elderly, and prevention of vitamin D deficiency: of calculation 800-1600 IU per day. Vitamin D deficiency or insufficiency in adolescents 12–18 years of age: at the rate of 800 IU per day. Treatment is carried out only under medical supervision. During vitamin D therapy, the level of intake of calcium and phosphorus is of great importance for achieving the effect. Before starting vitamin D therapy, the patient's dietary habits should be carefully assessed and the addition of foods fortified with vitamin D should be recommended. The drug is taken with or without food. The tablet should be swallowed whole (without chewing) and washed down with water. Certain populations are at high risk of vitamin D deficiency and may require higher doses and monitoring of serum 25(OH)-D concentrations for these groups: alcoholics; institutionalized or hospitalized persons; blacks; patients with diseases of the hepatobiliary system - impaired hepatic function, cirrhosis, obstructive jaundice; patients with malabsorption, including those suffering from inflammatory bowel disease, persistent diarrhea and celiac disease; obese patients; patients with diagnosed osteoporosis; patients using concomitant medications (eg, anticonvulsants, glucocorticoids); individuals with limited sun exposure, including children; in general, vitamin D absorption will be impaired in any condition in which fat malabsorption occurs, such as steatorrhea. Before starting treatment with vitamin D, it is necessary to evaluate the level of calcium and phosphate in the blood. To ensure the effectiveness of treatment, it is necessary to ensure adequate calcium intake from food. Due to variation in individual sensitivity to vitamin D, its dosage may be adjusted depending on clinical effectiveness. When choosing a dose of vitamin D, it is necessary to take into account the amount of vitamin D intake from other sources. In patients on hemodialysis, phosphate binders (phosphate binders) may be used to control elevated plasma phosphate levels. During vitamin D therapy, an increase in the dose of phosphate binders may be required due to improved absorption of phosphate. The plasma product of calcium and phosphorus (Ca P, mg / dL) should not exceed 60. Vitamin D deficiency in the body due to malabsorption or liver disease often requires the use of higher doses for treatment, up to 1 mg (40,000 IU) daily. Doses up to 2.5 mg (100,000 IU) may be used to treat hypocalcemia due to hypoparathyroidism. Observation of patients The following indicators may be useful in monitoring patients (if necessary, depending on the patient's condition, indicators of other tests may be required): The concentration of calcium in the blood or the level of ionized plasma calcium. Due to the narrow therapeutic range, it is recommended to measure these values at least once a week in the early period of treatment, then periodically during treatment. If possible, it is worth determining the concentration of both free and bound calcium in the blood. The level of alkaline (alkaline) phosphatase in the blood plasma, the concentration of phosphates in the blood, the concentration of calcium in 24-hour urine, the ratio of calcium and creatinine in the urine. It is recommended to determine these indicators every 1-3 months during therapy. Plasma urea nitrogen and plasma creatinine. Periodic determination is recommended in patients receiving therapeutic doses. Special groups of patients: Children Devit 50,000 is not recommended for children under 12 years of age due to the inability of many to swallow the tablet safely. Elderly Patients Studies show that older patients may have an increased need for vitamin D due to a reduction in the skin's ability to synthesize previtamin D3, or reduced sun exposure, or impaired renal function, or impaired vitamin D absorption. 25-hydroxycholecalciferol in blood plasma. Patients with impaired liver function Vitamin D deficiency in the body in liver disease often requires the use of higher doses for treatment. To select the dosage, it is necessary to focus on the concentration of 25-hydroxycholecalciferol in the blood plasma. If you forget to take Devit 50,000, do not take a double dose to make up for the missed one! Do not stop taking the medicine without first consulting with your doctor! If you have any doubts or questions, please contact your doctor. Use during pregnancy and lactation There are limited data on the use of cholecalciferol in pregnant women. Animal studies have shown its reproductive toxicity. During pregnancy, high doses of vitamin D are not recommended due to the possibility of a teratogenic effect in case of an overdose. Also, in pregnant women, vitamin D overdose should be avoided, as prolonged hypercalcemia has sometimes been associated with retardation of physical and mental development, supravalvular aortic stenosis, and retinopathy in the child. During breastfeeding, it is necessary to take the drug with caution, since when the mother takes a large dose of the drug, symptoms of hypercalcemia in the child are possible. PrecautionsVitamin D should be used with caution in patients with impaired renal function, and monitoring of calcium and phosphate levels is recommended while taking the drug. The risk of soft tissue calcification should be considered. Since vitamin D in the form of cholecalciferol cannot be normally metabolized in patients with severe renal insufficiency, other forms of vitamin D should be prescribed to such patients (see section "Contraindications"). Caution should be exercised when using vitamin D in patients with cardiovascular diseases receiving treatment with appropriate drugs (cardiac glycosides, diuretics). Cholecalciferol should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D to its active form. In such patients, it is necessary to monitor the content of calcium in the blood serum and urine. The concomitant use of multivitamin preparations and dietary supplements containing vitamin D should be avoided. There are reports that high oral doses of vitamin D (500,000 IU as a single bolus) led to an increase in the risk of fractures in the elderly, the greatest increase occurred during the first 3 months after taking the drug. Treatment with vitamin D may reveal previously undiagnosed primary hyperparathyroidism. Corrected serum calcium levels should be checked 1 month after the end of the exercise regimen or after the start of vitamin D supplementation in case of primary hyperparathyroidism. During treatment, it is necessary to regularly monitor the concentration of calcium in plasma (initially weekly, then once every 2-4 weeks). During long-term treatment, in addition, urinary calcium excretion and renal function should be monitored by measuring serum creatinine levels. Monitoring is particularly important in elderly patients who are concomitantly taking cardiac glycosides or diuretics and in cases of hyperphosphatemia, as well as in patients at increased risk of stone formation. In case of hypercalciuria (more than 300 mg (7.5 mmol) / 24 hours), or if there are signs of impaired renal function, the dose should be reduced or treatment should be discontinued. Similar monitoring is needed for children whose mothers were treated with vitamin D at pharmacological doses. Some children may react with hypersensitivity to the effects of vitamin D. Tablets should not be taken in case of pseudohypoparathyroidism (vitamin D requirements may be reduced by sometimes normal vitamin D sensitivity with risk of overdose with long-term use). In such cases, other vitamin D derivatives are available. Other drug interactions metabolic inactivation. The simultaneous use of glucocorticoids may reduce the effect of vitamin D. Systemic corticosteroids inhibit calcium absorption. Long-term use of corticosteroids may be compensated by the influence of vitamin D. In cases of treatment with drugs containing digitalis or other cardiac glycosides, the simultaneous use of vitamin D may increase the risk of cardiac glycoside toxicity (arrhythmias). Strict medical supervision is required, as well as monitoring of serum calcium concentration and ECG - if necessary. Concomitant use of ion exchange resins such as cholestyramine or laxatives such as paraffin oil may decrease gastrointestinal absorption of vitamin D. Thiazide diuretics reduce urinary calcium excretion. Taking large amounts of vitamin D along with diuretics can lead to excess calcium in the body. In cases of simultaneous treatment with thiazide diuretics, which reduce the excretion of calcium in the urine, it is recommended to monitor the concentration of calcium in the blood serum. The cytotoxic agent actinomycin and the antifungal agents imidazole, when interacting with vitamin D, inhibit the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the action of the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase. The use of calcium-containing foods in high doses may increase the risk of hypercalcemia. Foods containing magnesium (such as antacids) should be avoided as this may lead to a risk of hypermagnesemia. Vitamin D increases the absorption of drugs containing phosphorus and the risk of hyperphosphatemia. Co-administration of calcitonin, etidronate, gallium nitrate, pamidronate, plicamycin with vitamin D may antagonize the effect of these drugs in the treatment of hypercalcemia. Interactions with other drugs Concomitant use of anticonvulsants (eg, phenytoin), hydantoin, primidone, or barbiturates (and possibly other drugs that induce liver enzymes) may reduce the effect of vitamin D due to metabolic inactivation. The simultaneous use of glucocorticoids may reduce the effect of vitamin D. Systemic corticosteroids inhibit calcium absorption. Long-term use of corticosteroids may be compensated by the influence of vitamin D. In cases of treatment with drugs containing digitalis or other cardiac glycosides, the simultaneous use of vitamin D may increase the risk of cardiac glycoside toxicity (arrhythmias). Strict medical supervision is required, as well as monitoring of serum calcium concentration and ECG - if necessary. Concomitant use of ion exchange resins such as cholestyramine or laxatives such as paraffin oil may decrease gastrointestinal absorption of vitamin D. Thiazide diuretics reduce urinary calcium excretion. Taking large amounts of vitamin D along with diuretics can lead to excess calcium in the body. In cases of simultaneous treatment with thiazide diuretics, which reduce the excretion of calcium in the urine, it is recommended to monitor the concentration of calcium in the blood serum. The cytotoxic agent actinomycin and the antifungal agents imidazole, when interacting with vitamin D, inhibit the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the action of the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase. The use of calcium-containing foods in high doses may increase the risk of hypercalcemia. Foods containing magnesium (such as antacids) should be avoided as this may lead to a risk of hypermagnesemia. Vitamin D increases the absorption of drugs containing phosphorus and the risk of hyperphosphatemia. Co-administration of calcitonin, etidronate, gallium nitrate, pamidronate, plicamycin with vitamin D may antagonize the effect of these drugs in the treatment of hypercalcemia. Contraindications Hypersensitivity to vitamin D or drug components. Hypervitaminosis D. Renal osteodystrophy with hyperphosphatemia. Hypercalcemia and/or hypercalciuria. Urolithiasis, the presence or risk of calcium kidney stones. Severe renal failure. Children's age up to 12 years. Composition Each film-coated tablet contains: Active ingredients: 50,000 IU vitamin D3 (equivalent to 1.25 mg cholecalciferol) 500 mg; Auxiliary ingredients: microcrystalline cellulose PH 102:290, hydrated colloidal silicon dioxide, anhydrous dicalcium phosphate, magnesium stearate, sodium croscarmellose; Shell: hydroxypropyl methylcellulose, microcrystalline cellulose, stearic acid, titanium dioxide E171, red iron oxide E172. Overdose Excessive intake of vitamin D leads to the development of hypercalcemia and its associated effects, including hypercalciuria, ectopic calcification, kidney damage, and cardiovascular damage. Overdose symptoms include: anorexia, fatigue, nausea and vomiting, diarrhea, polyuria, sweating, headache, thirst and dizziness, bone pain, arrhythmias, coma and even death (with severe hypercalcemia), irreversible kidney damage (with persistent hypercalcemia). Individual intolerance to vitamin D varies considerably; newborns and children tend to be more sensitive to its toxic effects. Recommended treatment: Vitamin D hypervitaminosis is treated with vitamin withdrawal, a low-calcium diet, and copious fluid intake. If hypercalcemia persists, a low-calcium diet may be instituted and prednisolone may be started. Severe hypercalcemia can be treated with calcitonin, etidronate, pamidronate, or gallium nitrate. Hypercalcemic crisis requires intensive hydration with saline sodium chloride to increase calcium excretion, with or without loop diuretics. Cardiac arrhythmias can be treated with low doses of potassium with continuous cardiac monitoring. Carcinogenicity, mutagenicity, impaired reproductive function It has been established that cholecalciferol in high doses (4-15 times higher than the permissible human dose) has a teratogenic effect in animals. Offspring of pregnant female rabbits treated with high doses of vitamin D had anatomical lesions identical to those of supravalvular aortic stenosis, and offspring that did not show signs of such changes showed vasculotoxicity similar to that seen in adults. in acute vitamin D intoxication. Side effects Like all medicines, Devit 50,000 can cause side effects. Side effects associated with the use of Devit 50,000 may include: Uncommon side effects (less than 1 in 100 people) Excess calcium in the blood (hypercalcemia). Feeling nauseous, loss of appetite, constipation, abdominal pain, extreme thirst, muscle weakness, drowsiness or confusion. Excess calcium in the urine (hypercalciuria) Rare side effects (less than 1 in 1,000 people) Skin rash, pruritus, urticarial rash, swelling of the face, swelling of the genitals, dry skin, nail lesions, dry mouth, loss of appetite, rash erythematous, purpuric rash , shortness of breath and dysphagia. Growth retardation is possible in children, especially after taking cholecalciferol for a long period of time at a dose of 45 micrograms (1800 units) per day. Early symptoms of vitamin D hypervitaminosis due to hypercalcemia: constipation, as a rule, more often in children and adolescents; diarrhea; dry mouth; prolonged headache; increasing thirst; increased frequency of urination, especially at night, or increased volume of urine; loss of appetite; metallic taste in the mouth; nausea or vomiting (more common in children and adolescents); unusual tiredness or general weakness. Late symptoms of vitamin D hypervitaminosis due to hypercalcemia: bone pain; cloudy urine; arterial hypertension; photosensitivity or eye irritation; arrhythmia; skin itching; lethargy (drowsiness); muscle pain; nausea or vomiting, pancreatitis (severe abdominal pain); psychosis, mood changes or mental changes; rapid weight loss. If the listed adverse reactions occur, as well as reactions not indicated in the instructions, the patient is advised to contact their doctor. Storage conditionsStore in a place protected from moisture at a temperature not exceeding +30 °C. Keep out of the reach of children. Buy Devit 50000 tablets p/o 50000ME No. 8x1