D-Vit Lamira tablets p/o 5000 IU № 15×2

NameD-vit Lamira 5 thousand ME. Release form Tablets 5 thousand ME. MNNcholecalciferol. Qualitative and quantitative composition Each film-coated tablet contains: Active ingredients: 5000 IU vitamin D3 (equivalent to 125 mcg cholecalciferol) 50 mg; Auxiliary ingredients: microcrystalline cellulose PH102, hydrated colloidal silicon dioxide, anhydrous dicalcium phosphate, magnesium stearate, sodium croscarmellose; Shell: Sepifilm LP014 transparent (hydroxypropyl methylcellulose, microcrystalline cellulose, stearic acid), Sepispers dry 5047 red (hydroxypropyl methylcellulose, microcrystalline cellulose, titanium dioxide E171, iron oxide red E172). Pharmacotherapeutic group Vitamins. Vitamin D and analogues. ATX code: A11CC05 Pharmacological properties Pharmacodynamics Cholecalciferol (vitamin D3) is formed in the skin under the influence of ultraviolet radiation and is converted into a biologically active form, 1,25-hydroxycholecalciferol, in two stages of hydroxylation: the first occurs in the liver (position 25), the second – in the kidneys ( position 1). Along with parathyroid hormone and calcitonin, 1,25-hydroxycholecalciferol has a significant effect on the regulation of calcium-phosphorus metabolism. In its biologically active form, vitamin D enhances calcium absorption in the intestine, calcium incorporation into the osteoid, and calcium release from bone tissue. In vitamin D deficiency, skeletal calcification does not occur (leading to rickets) or bone decalcification occurs (leading to osteomalacia). Deficiency of calcium and/or vitamin D causes a reversible increase in parathyroid hormone secretion. Such secondary hyperparathyroidism causes an increase in bone metabolism, which in turn can lead to bone fragility and fractures. According to its production, physiological regulation and mechanism of action, vitamin D can be regarded as a steroid hormone precursor. In addition to cholecalciferol, which is formed under physiological conditions in the skin, additional amounts can be ingested with food or in the form of drugs. Since in the latter case, inhibition of the formation of vitamin D synthesis does not occur, overdose and symptoms of intoxication may develop. Ergocalciferol (vitamin D2) is synthesized by plants. The human body metabolizes it into its active form in a manner similar to the activation of cholecalciferol. It has the same quantitative and qualitative characteristics. Pharmacokinetics At doses taken with food, vitamin D is almost completely absorbed along with alimentary lipids. At higher doses, approximately two-thirds of vitamin D is absorbed. The skin synthesizes vitamin D from 7-dehydrocholesterol under the action of ultraviolet radiation. Vitamin D is carried to the liver by a specific transport protein. In the liver, it is metabolized by microsomal hydroxylase to 25-hydroxycholecalciferol. Vitamin D and its metabolites are excreted from the body with bile and feces. Vitamin D is stored in muscle and adipose tissue and therefore has a long biological half-life. After taking high doses of vitamin D, plasma concentrations of 25-hydroxyvitamin D may remain elevated for several months. Hypercalcemia caused by an overdose of vitamin D may persist for several weeks (see also section “Overdose”). Pharmaceutical propertiesPharmaceutical intolerances None. Indications for use – Prevention and treatment of vitamin D deficiency in adults and adolescents (12 to 18 years of age); – As an adjunct to specific therapy for osteoporosis in patients at risk of vitamin D deficiency, preferably in combination with calcium. Dosage and administration The drug is taken orally, during meals. Prevention and treatment of vitamin D deficiency in adults and adolescents (12 to 18 years of age). – The prophylactic dose of vitamin D is determined individually by the doctor, taking into account age, intake of vitamin D from other sources (food, insolation), overweight (obesity) of the patient, taking drugs that affect the metabolism of vitamin D. The usual recommended dose is 500-1000 IU vitamin D per day. – The therapeutic dose of vitamin D and the duration of treatment is determined individually by the doctor, taking into account the initial severity of vitamin D deficiency, confirmed by laboratory, age, intake of vitamin D from other sources (food, insolation), overweight (obesity) of the patient, taking medications that affect on the metabolism of vitamin D. The usual recommended dose is 5000 – 6000 IU of vitamin D per day. The duration of treatment is up to 6-8 weeks, followed by laboratory monitoring of the concentration of 25-(OH) D in the blood and the decision on the duration of the intake or the transition to a prophylactic dose. Higher doses may be prescribed individually at the discretion of the physician, taking into account the benefit-risk ratio. As an adjunct to specific osteoporosis therapy in patients at risk of vitamin D deficiency: The recommended dose of vitamin D is 800-2000 IU of vitamin D per day. For elderly patients who are particularly at risk for fractures, the recommended dose is 2000 IU of vitamin D per day. Patients should receive additional calcium if their dietary intake is insufficient. Certain groups of patients at high risk of vitamin D deficiency may require higher dosages, and it is necessary to monitor the concentration of 25-(OH) D in the blood: persons suffering from alcoholism institutionalized or hospitalized persons dark-skinned patients with diseases of the hepatobiliary system – impaired hepatic function, cirrhosis, obstructive jaundice patients with malabsorption, incl. people with malabsorption, inflammatory bowel disease, and celiac disease people with insufficient sun exposure due to protective clothing or constant use of sunscreen people who are obese people diagnosed with osteoporosis people taking concomitant medications (eg, anticonvulsants, glucocorticoids) people who have undergone therapy vitamin D deficiency who require maintenance therapy for persons with limited sun exposure, including children. Dosage in hepatic impairment Dose adjustment is not required. Dosage in Renal Insufficiency Vitamin D should not be used in patients with severe renal insufficiency. Infants and children (0-12 years) Not recommended for children under 12 years of age. Older age Vitamin D requirements may increase in older age due to decreased absorption of vitamin D, decreased ability of the skin to synthesize provitamin D, decreased sun exposure, and increased incidence of kidney failure. The dose of treatment for vitamin D deficiency in the elderly is determined individually by the doctor, depending on the course and severity of the disease. If you forget to take D-Vit Lamira, 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. Contraindications – Hypersensitivity to vitamin D or drug components. – Hypervitaminosis D. – Renal osteodystrophy with hyperphosphatemia. – Hypercalcemia and/or hypercalciuria. – Urolithiasis disease. – Severe renal failure. – Children’s age up to 12 years. Precautions: – Pregnancy – Sarcoidosis Precautions 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. Patients should receive additional calcium if dietary intake is inadequate. When choosing a dose of vitamin D, it is necessary to take into account the amount of its intake from other sources (in food, dietary supplements and from sun exposure). The dosage is chosen individually. During vitamin D therapy, the level of intake of calcium and phosphorus is of great importance for achieving the effect. All patients taking pharmacologic doses of vitamin D should have their plasma calcium levels checked regularly with each episode of vomiting. Due to variation in individual sensitivity to vitamin D, its dosage may be adjusted depending on clinical effectiveness. 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 that these parameters be determined 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 the 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. To avoid hypercalcemia, treatment should be carried out under medical supervision. Calcium supplements should be used under medical supervision and calcium and phosphate levels should be monitored. The risk of soft tissue calcification should also be considered. Calcium absorption can be reduced by oral administration of sodium sulfate or parenteral administration of magnesium sulfate. Vitamin 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). 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. The tablets should not be taken in case of pseudohypoparathyroidism (vitamin D requirement may be reduced by sometimes normal vitamin D sensitivity with risk of overdose if taken long term). In such cases, other vitamin D derivatives are available. 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. 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. 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. Use in pregnancy and lactation There are limited data on the use of cholecalciferol in pregnant women. Animal studies have shown its reproductive toxicity. 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. The recommended daily dosage for pregnant and lactating women is 400 IU, however higher dosages (up to 2000 IU/day) may be necessary for women with vitamin D deficiency. application requirements depend on the severity of the disease and the clinical response. Vitamin D and its metabolites are excreted into breast milk; however, no cases of overdose have been reported in infants due to vitamin D content in mother’s milk. When prescribing vitamin D to a child, the doctor should take into account the additional dosage of vitamin D taken by the nursing mother of the child. Interactions with other drugs Concomitant use of anticonvulsants (eg, phenytoin), hydantoin, primidone, or barbiturates (and possibly other drugs that cause induction of 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 calcium concentration in the blood serum 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. Phosphate solutions should not be used to reduce hypercalcemia in hypervitaminosis D due to the risk of metastatic calcification. 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. Influence on the ability to drive vehicles and work with dangerous devices and mechanismsD-Wit Lamira does not affect the ability to drive vehicles and work with mechanisms. Side effects Side effects are listed by organ system class and frequency. Frequency is defined as: sometimes (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000) or unknown (cannot be estimated from the available information). Immune system disorders Not known: hypersensitivity reactions such as angioedema, laryngeal edema Metabolic and nutritional disorders Uncommon: hypercalcemia and hypercalciuria Skin and subcutaneous tissue disorders Rare: pruritus, rash and urticaria Growth retardation may occur in children, especially after taking cholecalciferol over a long period of time at a dose of 45 mcg (1800 units) per day. Early symptoms of vitamin D hypervitaminosis due to hypercalcemia: Constipation tends to be more common 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 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. Reporting adverse reactions If you experience any adverse reactions, tell your doctor. This also applies to any unwanted reactions that are not listed in this leaflet. You can report adverse reactions to the information database on adverse reactions (actions) to medicinal products, including reports of drug inefficiency identified in the Republic of Belarus (UE "Center for Expertise and Testing in Healthcare" of the Ministry of Health of the Republic of Belarus, www.rceth .by). By reporting adverse reactions, you help to get more information about the safety of the drug. 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, reproductive dysfunction. 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 case of acute vitamin D intoxication. Shelf life 3 years Do not use after the expiry date stated on the package. Storage conditionsStore in a place protected from moisture at a temperature not exceeding 30°C. Keep out of the reach of children. Terms of release Release by prescription. Upakovka15 film-coated tablets in PVC / PVDC-aluminum blister, 1 or 2 blisters, together with instructions for medical use for patients, are packed in a cardboard box. 30 film-coated tablets in PVC / PVDC-aluminum blister, 1 or 2 blisters, together with instructions for medical use for patients, are packed in a cardboard box. Buy D-Vit Lamira tablets p / o 5000 IU No. 15x2 Vit Lamira tablets p/o 5000 IU No. 15x2 Instructions for use for D-Vit Lamira tablets p/o 5000 IU No. 15x2