Detriol oil solution for oral administration 0.425mg/ml 5ml №1

Name:
Detriol.
Description:
Transparent viscous solution. Composition 1 ml of the drug (34 drops) contains: active ingredient: cholecalciferol – 0.425 mg (corresponding to 17,000 IU of vitamin D3); excipients: medium chain triglycerides – 925.6 mg. Pharmacotherapeutic group Vitamins. Vitamin D and its analogues. ATX code: A11CC05. Pharmacological properties The most important function of vitamin D3 is the regulation of calcium and phosphate metabolism, which contributes to proper mineralization and skeletal growth. Cholecalciferol (vitamin D3) in a biologically active form – 1,25-hydroxycholecalciferol has a significant effect on the regulation of calcium-phosphorus metabolism: it enhances the absorption of calcium in the intestine, the incorporation of calcium into bone tissue and regulates the release of calcium from it. With a deficiency of vitamin D3, there is no calcification of the skeleton in children (which leads to the development of rickets) or decalcification of the bones in adults is observed (which leads to osteomalacia). Deficiency of calcium and/or vitamin D3 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. Vitamin D3 plays an important role in the absorption of calcium and phosphate from the intestines, in the transport of mineral salts and in the process of bone calcification, and also regulates the excretion of calcium and phosphate by the kidneys. The concentration of calcium ions in the blood determines the maintenance of skeletal muscle tone, myocardial function, promotes the conduction of nervous excitation, regulates the process of blood clotting, improves the functioning of the immune system, affecting the production of lymphokines. According to its production, physiological regulation and mechanism of action, vitamin D3 can be regarded as a precursor of a steroid hormone. 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. Lack of vitamin D3 in food, impaired absorption, calcium deficiency, as well as insufficient exposure to sunlight during the period of rapid growth of the child lead to rickets, in adults to osteomalacia, in pregnant women symptoms of tetany may occur, violation of the processes of calcification of the bones of newborns. An increased need for vitamin D3 occurs in women during menopause, because, due to hormonal disorders, they often develop osteoporosis. Indications for use Prevention of rickets and osteomalacia in children and adults; prevention of diseases associated with vitamin D3 deficiency in otherwise healthy children and adults without impaired absorption; as an adjunct to specific therapy for osteoporosis in adult patients at risk of vitamin D deficiency; prevention of rickets in premature newborns; prevention of diseases associated with vitamin D3 deficiency in high-risk groups in children and adults with malabsorption syndrome; treatment of rickets and osteomalacia in children and adults; treatment of hypoparathyroidism in adults. Dosage and administration The drug is taken orally. Detriol should be added to food or drink (water, milk) immediately before its use. For small children, give drops in a teaspoon of water, milk or baby food. If the drops are added to a feeding bottle or plate, it must be ensured that the food is consumed completely, otherwise the entire dose of the drug cannot be guaranteed. For adults and older children, take the medicine in a spoonful of liquid. 1 drop of Detriol contains about 500 IU of vitamin D3. Use only the dropper that comes with this medicine to take the correct dose! In order to accurately measure the dose of the drug, it is necessary to hold the vial at an angle of 45 ° while counting drops. The dose of the drug should be set individually, taking into account the total use of calcium (both in the daily diet and in the form of medicines). Prevention of rickets in premature newborns: the dose is determined by the doctor. The usual recommended dose is 2 drops (about 1000 IU of vitamin D3) per day. Prevention of rickets in children: the recommended dose is 1 drop (about 500 IU of vitamin D3) per day. Treatment of rickets in children: the dose is determined individually by the doctor, depending on the course and severity of the disease. The usual recommended dose for treating vitamin D3 deficiency in infants and children is 2-10 drops (about 1000-5000 IU of vitamin D3) per day. Prevention of vitamin D3 deficiency in high-risk patients without malabsorption disorders: the recommended dose is 1 drop (about 500 IU of vitamin D3) per day. Prevention of vitamin D3 deficiency in malabsorption: the dose is determined individually by the doctor. The usual recommended dose is 6-10 drops (about 3000-5000 IU of vitamin D3) per day. Supportive treatment of osteoporosis: the recommended dose is 2 drops (about 1000 IU of vitamin D3) per day. Treatment of vitamin D3 deficiency in adults: The dose depends on the severity of the deficiency. The generally recommended dose for the treatment of vitamin D deficiency in adults is 2-10 drops of an oil solution (corresponding to about 1000-5000 IU of vitamin D3) per day. Treatment of hypoparathyroidism: The recommended dose depends on the level of calcium in the blood serum and is 20-40 drops (about 10,000-20,000 IU of vitamin D3) per day. If you need to take higher doses of cholecalciferol, you should use drugs in a higher dosage. With long-term treatment with Detriol, it is recommended to regularly monitor the level of calcium in the blood serum and in the urine, as well as the state of kidney function by measuring creatinine in the blood. If necessary, adjust the dose in accordance with the values of calcium in the blood serum. Duration of administration Prevention of rickets in children: from the second week of life to the end of the first year of life, in the second year of life it may be necessary to use vitamin D3, especially during the winter months. Adults and older children: the duration of the drug depends on the severity and course of the disease. Treatment of rickets and osteomalacia associated with vitamin D deficiency should be continued for 1 year. If you miss another dose, do not take a double dose, but take the next dose at the same time as your next dose. Side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequency of adverse reactions is regarded as unknown, since large-scale clinical trials that would establish their frequency have not been conducted. Adverse reactions are practically not observed when taking the recommended doses of the drug. In the case of rarely observed hypersensitivity to vitamin D3 or when using very high doses for a long time, a poisoning called hypervitaminosis D3 can occur. The following adverse reactions have been registered: Hypercalcemia and hypercalciuria; Constipation, flatulence, nausea, abdominal pain, diarrhea; Hypersensitivity reactions such as itching, rash, urticaria. Reporting adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Contraindications Hypersensitivity to the components of the drug, hypercalcemia, hypercalciuria, renal failure. Hypervitaminosis D, urolithiasis with the presence of calcium stones in the kidneys; severe arteriosclerosis, diseases and/or conditions leading to hypercalcemia or hypercalciuria. OverdoseOverdose symptoms: Acute and chronic overdose of vitamin D3 can lead to the development of potentially life-threatening conditions. Vitamin D3 actively influences the phosphorus-calcium metabolism and its acute and chronic overdose leads to hypercalcemia, hypercalciuria, kidney calcification and bone damage, as well as disorders of the cardiovascular system. Hypercalcemia occurs after prolonged intake of vitamin D3 in doses of 50,000-100,000 IU / day. Symptoms are not specific and may include cardiac arrhythmias, thirst, dehydration, lethargy, and impaired consciousness. In addition, chronic overdose can lead to the deposition of calcium in the vessels and tissues of the body. Daily doses up to 500 IU / day Prolonged overdose of vitamin D3 can cause the development of hypercalcemia and hypercalciuria. The use of excessive doses for an extended period of time can lead to calcification of parenchymal organs. Daily doses over 500 IU/day Cholecalciferol (vitamin D3) has a relatively low therapeutic index. The threshold for vitamin D3 intoxication ranges from 40,000-100,000 IU per day when taken for 1-2 months in adults with normal parathyroid function. Newborns and young children may be sensitive to lower doses, so vitamin D3 should not be prescribed without medical supervision. An overdose leads to an increase in the level of phosphorus in the blood serum and urine, as well as to hypercalcemic syndrome, followed by calcium deposition in tissues, primarily in the kidneys (nephrolithiasis, nephrocalcinosis) and blood vessels. Symptoms of intoxication are nonspecific and are manifested by nausea, vomiting, diarrhea at the beginning, later by constipation, anorexia, lethargy, headache, muscle and joint pain, muscle weakness, as well as constant drowsiness, azotemia, polydipsia and polyuria, pre-terminal exicosis. Typical biochemical findings are hypercalcemia, hypercalciuria, and an increase in serum 25-hydroxycalciferol levels. Treatment of overdose There is no specific antidote. Daily doses up to 500 IU / day To eliminate the symptoms of chronic overdose of vitamin D3, forced diuresis may be required, as well as the introduction of glucocorticosteroids and calcitonin. Daily doses of more than 500 IU / day In case of overdose, it is necessary to take measures to treat persistent, and under certain conditions, life-threatening hypercalcemia. The first aid for an overdose of vitamin D3 is the abolition of the drug; it may take several weeks to normalize the concentration of calcium in the blood caused by vitamin D3 intoxication. Depending on the severity of hypercalcemia, the following measures can be used: a diet low in or no calcium, intake of large amounts of fluid, forced diuresis, in some cases, the appointment of glucocorticosteroids and calcitonin. With normal renal function, calcium levels can be sufficiently reduced by intravenous administration of 0.9% sodium chloride solution (3-6 liters for 24 hours) with the concomitant administration of furosemide and, in some cases, sodium edetate at a dose of 15 mg / kg of body weight / hour in combination with constant monitoring of calcium levels in the blood and ECG. In oligo- and anuria, on the contrary, it is necessary to carry out hemodialysis using calcium-free dialysate. With long-term therapy with high doses of vitamin D3, it is recommended to monitor the development of symptoms of a potential overdose (nausea, vomiting, diarrhea at the initial stage, later constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia, polydipsia and polyuria). Precautions When prescribing other drugs containing vitamin D3, it is necessary to take into account its dose as part of the drug Detriol. Additional doses of vitamin D3 or calcium should only be taken under medical supervision. In such cases, it is necessary to monitor the concentration of calcium in serum and urine. In patients with renal insufficiency receiving treatment with cholecalciferol, it is necessary to monitor its effect on calcium and phosphate metabolism. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolized, so other forms of vitamin D should be used. Cholecalciferol should not be given to patients with a predisposition to the formation of calcium-containing kidney stones. In patients with a history of kidney stones, urinary calcium excretion should be measured to rule out hypercalciuria. There is no clear evidence of causation between vitamin D use and kidney stones, but a risk is likely, especially in the case of concomitant calcium supplementation. The need for additional calcium supplements should be considered on an individual basis. Calcium supplements should be given under close medical supervision. Special care should be taken when prescribing cholecalciferol in violation of the excretion of calcium and phosphate in the urine, in the treatment of benzothiadiazine derivatives, as well as in patients with limited mobility (risk of developing hypercalcemia and hypercalciuria). In such patients, it is necessary to monitor the concentration of calcium in serum and urine. Cholecalciferol should be used with caution in other patients at increased risk of hypercalcemia, such as those with malignant neoplasms. With caution, cholecalciferol should be prescribed in sarcoidosis due to the risk of increasing the level of its transformation into an active metabolite. In such patients, it is necessary to monitor the concentration of calcium in serum and urine. Cholecalciferol should not be taken in pseudohypoparathyroidism, since in the phase of normal sensitivity to vitamin D3, the need for it may decrease, which leads to the risk of delayed overdose. In such cases, it is better to use other derivatives of vitamin D, which allow more precise regulation of the dosage. Patients who receive the drug to compensate for vitamin D deficiency, it is recommended to control 25-(OH)-D before starting treatment and approximately three to four months after the start of therapy, as needed. Patients with obesity, malabsorption syndrome, or concomitant medications may not respond to treatment or may require higher doses due to effects on vitamin D absorption. In such cases, the patient’s vitamin D levels should be monitored and dosed according to generally accepted recommendations. in medical practice. Patients who remain deficient or fail to respond to recommended doses should be switched to alternative therapies. Daily doses above 500 IU/day In long-term treatment with doses above 500 IU of vitamin D3 per day, it is necessary to monitor the concentration of calcium in the blood serum and urine, as well as monitor kidney function by measuring the level of serum creatinine. The implementation of this monitoring is especially important in elderly patients, as well as in concomitant treatment with cardiac glycosides or diuretics. With hypercalcemia or symptoms of impaired renal function, a decision should be made to reduce the dose of the drug or stop treatment. Dose reduction or discontinuation of treatment is recommended when urinary calcium levels exceed 7.5 mmol/24 hours (300 mg/24 hours). Daily doses over 1000 IU/day In long-term treatment with doses above 1000 IU of vitamin D3 per day, it is necessary to monitor the concentration of calcium in the serum. Very high doses of vitamin D3 used for a long time or loading doses can cause chronic hypervitaminosis. When conducting long-term therapy with a dose of more than 1000 IU of vitamin D3, it is necessary to control the level of calcium in the blood serum. After opening the bottle with the drug, it is recommended to use it within 3 months. Use during pregnancy and lactation Pregnancy During pregnancy and during breastfeeding, an adequate intake of vitamin D3 is required. Daily doses up to 500 IU/day To date, information on the risk of using cholecalciferol in this dose range has not been received. Daily doses above 500 IU/day Cholecalciferol should be prescribed during pregnancy only if clearly needed and only in doses that are absolutely necessary to eliminate its deficiency. An overdose of vitamin D3 during pregnancy should be avoided because the resulting hypercalcemia can lead to delayed physical and mental development, the development of supravalvular aortic stenosis and retinopathy in the child. Breastfeeding Vitamin D3 and its metabolites pass into breast milk, but there have been no cases of overdose in newborns as a result of breastfeeding. Fertility No data are available on the effect of vitamin D3 treatment on fertility. Influence on the ability to drive vehicles and work with mechanisms The study of the effect on the ability to drive a vehicle and work with mechanisms has not been conducted. Interaction with other medicinal products Inducers of CYP450 metabolic enzymes such as rifampicin, carbamazepine, phenytoin, barbiturates (eg phenobarbital), primidone and glucocorticoids may reduce the effectiveness of vitamin D3 due to increased inactivation. The concomitant use of these drugs may increase the need for vitamin D. Therefore, during joint use, an increase in the dose of cholecalciferol may be required. Isoniazid may reduce the effectiveness of vitamin D3 by inhibiting the metabolic activation of vitamin D. Drugs that cause fat malabsorption, such as orlistat and cholestyramine, or laxatives, such as paraffin oil, may reduce gastrointestinal absorption of vitamin D3. Cytotoxic agents such as actinomycin and antifungals such as imidazole interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme 25-hydroxyvitamin D-1 hydroxylase. Thiazide diuretics: may reduce the excretion of calcium in the urine and, accordingly, increase the risk of developing hypercalcemia. In such patients, it is necessary to constantly monitor the concentration of calcium in the blood and urine. Cardiac glycosides: Oral administration of vitamin D3 may reduce their effectiveness and increase toxicity due to increased calcium levels (risk of developing cardiac arrhythmias). In such patients, it is necessary to monitor the levels of calcium in plasma and urine, ECG, and (if indicated) the levels of digoxin and digitoxin in the blood plasma. Vitamin D metabolites or analogues (e.g. calcitriol): Vitamin D3 may be combined with vitamin D metabolites or analogues only in exceptional cases and under control of plasma calcium levels. Magnesium-containing drugs (eg, antacids) are not recommended during therapy, as this may lead to hypermagnesemia. Medicines containing high doses of calcium or phosphate increase the risk of developing hyperphosphatemia. Ketoconazole: May inhibit both biosynthesis and catabolism of cholecalciferol. Calcitonin, etidronate, pamidronate: Vitamin D3 may antagonize these drugs used in hypercalcemia. Vitamin D3 can increase the absorption of aluminum in the intestine. Packing 5 ml in a brown glass bottle, sealed with a dropper cap made of polyethylene and a tamper-evident screw cap made of polyethylene. One vial, together with the leaflet, is placed in a cardboard box. Storage conditions Store in a place protected from light at a temperature of 15 – 25 ° C. Keep out of the reach of children. Shelf life after opening the bottle – 3 months in a dark place at a temperature of 15-25 ° C. Shelf life 1 year. Do not use after the expiry date stated on the packaging. Terms of sale Without a prescription. Buy Detriol oily solution for oral administration 0.425mg/ml 5ml No. 1 Price for Detriol oily solution for oral administration 0.425mg/ml 5ml No.1