Aquadetrim drops for oral administration 15000m/ml 10ml №1

Name:
Aquadetrim drops for pr. inside 15000IU/ml in vial with cap.-cap.10ml in pack No. 1
Description:
Colorless, transparent or slightly opalescent liquid with an anise smell. The main active ingredientColecalciferol Release formDrops Dosage 15000 IU/ml Pharmacological actionPharmacodynamicsVitamin D3 is an active anti-rachitic factor. Vitamin D’s most important function is to regulate calcium and phosphate metabolism, which promotes proper mineralization and skeletal growth. Vitamin D3 is the natural form of vitamin D, which is produced in the human skin by exposure to sunlight. Compared to vitamin D2, it is characterized by a higher activity (by 25%). Cholecalciferol plays a significant role in the absorption of calcium and phosphate from the intestine, 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 muscle tone of the skeletal muscles, myocardial function, promotes the conduction of nervous excitation, and regulates the process of blood coagulation. Vitamin D is necessary for the normal function of the parathyroid glands, improves the functioning of the immune system, affecting the production of lymphokines. Lack of vitamin D 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, a violation of the processes of calcification of the bones of newborns. An increased need for vitamin D occurs in women during menopause, because due to hormonal disorders, they often develop osteoporosis. Pharmacokinetics In premature babies, there is insufficient formation and flow of bile into the intestine, which disrupts the absorption of vitamins in the form of oil solutions. An aqueous solution of vitamin D3 is absorbed better than an oil solution, provides the most rapid and complete onset of the clinical effect and higher efficiency in rickets and rickets-like conditions, including in children with malabsorption. After oral administration, cholecalciferol is absorbed in the small intestine. Metabolized in the liver and kidneys. The half-life of cholecalciferol from the blood is several days and may be prolonged in case of renal insufficiency. The drug crosses the placental barrier and into the mother’s milk. It is excreted from the body with urine and feces. Vitamin D3 has the property of cumulation. Indications for use Prevention of rickets and osteomalacia in children and adults. Prevention of rickets in premature babies. Prevention of vitamin D deficiency in children and adults at risk. Prevention of vitamin D deficiency in children and adults suffering from malabsorption. Treatment of rickets and osteomalacia in children and adults. Dosing and Administration Orally. The drug is taken in a spoonful of liquid. 1 drop contains about 500 IU of vitamin D3. In order to accurately measure the dose of the drug, it is necessary to hold the vial at an angle of 45 ° while counting the 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 drugs). Prevention of vitamin deficiency: Children from the first days of life and adults – 500 IU (1 drop) per day. Treatment of vitamin deficiency: The dose of the drug is determined by the doctor individually, depending on the state of vitamin deficiency. Vitamin D-dependent rickets: Children – from 3,000 IU to 10,000 IU (620 drops) per day. Osteomalacia associated with the use of anticonvulsants: Children – 1000 ME (2 drops) per day, adults – 10004000 ME (from 2 to 8 drops) per day. Application during pregnancy and lactation During pregnancy, vitamin D3 should be used only in dosages recommended by the doctor. It is not recommended to exceed the dosage of vitamin D3. High doses of vitamin D3 may be teratogenic. When breastfeeding, vitamin D3 should be used in dosages recommended by your doctor. High doses taken by the mother may cause overdose symptoms in the child. The ability to influence the reaction rate when driving vehicles or working with other mechanisms Does not affect. Precautions The drug should be used according to the indicated dosage, care should be taken: if the patient is motionless; if the patient is taking thiazide diuretics; if the patient has urolithiasis; if the patient suffers from heart disease; if the patient is taking digitalis glycosides; if the patient is pregnant or breastfeeding; if the patient is simultaneously taking high doses of calcium. The daily requirement and method of vitamin D administration in children should be determined individually and checked each time during periodic examinations, especially in the first months of life; in infants who have a small size of the anterior crown from birth. Very high doses of vitamin D3, used for a long time, or shock doses of the drug can be the cause of chronic hypervitaminosis. When conducting long-term therapy with a dose of more than 1000 IU of vitamin D, it is necessary to evaluate the level of calcium in the blood serum. The preparation contains benzyl alcohol in a dose (15 mg/ml) and sucrose. Do not use in persons sensitive to benzyl alcohol and with hereditary fructose intolerance. Interaction with other drugs Anticonvulsants, especially phenytoin and phenobarbital, as well as rifampicin, reduce the absorption of vitamin D3. The simultaneous use of vitamin D3 with thiazide diuretics increases the risk of hypercalcemia. Simultaneous use with cardiac glycosides may increase their toxicity (increased risk of developing cardiac arrhythmias). Simultaneous use with antacids containing magnesium and aluminum can lead to toxic effects of aluminum on the skeletal system and hypermagnesemia in patients with renal insufficiency. Co-administration with vitamin D analogs may lead to increased toxic effects. Preparations containing high doses of calcium or phosphate increase the risk of developing hyperphosphatemia. Ketoconazole can inhibit both the biosynthesis and catabolism of 1,25(OH)2-cholecalciferol. Vitamin D can lead to an antagonistic effect in relation to drugs used in hypercalcemia, such as: calcitonin, etidronate, pamidronate. Contraindications Hypersensitivity to the components of the drug, hypervitaminosis D, increased levels of calcium in the blood and urine, calcium kidney stones, sarcoidosis, renal failure. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome and sucrase-isomaltase deficiency should not take the drug. Composition 1 ml of solution (approx. 30 drops) contains: active substance: cholecalciferol (vitamin D3) 15,000 IU; excipients: macrogol glyceryl ricinoleate, citric acid monohydrate, sucrose, disodium phosphate dodecahydrate, benzyl alcohol, anise flavor, purified water. OverdoseVitamin D actively influences phosphorus-calcium metabolism, and its overdose leads to hypercalcemia, hypercalciuria, kidney calcification and bone damage, as well as to disorders of the cardiovascular system. Hypercalcemia occurs after prolonged use of vitamin D in doses of 50,000,100,000 IU/day. After an overdose of the drug develop: muscle weakness, lack of appetite, nausea, vomiting, constipation, severe thirst, polyuria, lethargy, conjunctivitis, pancreatitis, rhinorrhea, hyperthermia, decreased libido, hypercholesterolemia, increased activity of transaminases, arterial hypertension, heart rhythm disturbance and uremia. Frequent symptoms are headache, muscle and joint pain, weight loss. Kidney function is impaired, which is manifested by a decrease in the density of urine and the appearance of cylinders in the urine sediment. Overdose treatment a) Daily doses up to 500 IU/day Symptoms of chronic overdose of vitamin D may require forced diuresis, as well as the appointment of glucocorticoids or calcitonin. b) Doses above 500 IU/day Overdose requires measures to control persistent and, under some conditions, life-threatening hypercalcemia. As a priority, it is necessary to stop taking the drug; normalization of the level of calcium in the blood, increased as a result of vitamin D intoxication, will occur within a few weeks. Depending on the degree of hypercalcemia, the following measures may be required: a calcium-poor or calcium-free diet, adequate hydration, forced diuresis by prescribing furosemide, and prescribing glucocorticoids and calcitonin. If renal function is preserved, blood calcium levels can be reduced by infusion of isotonic saline (36 liters in 24 hours) with the addition of furosemide and, in selected cases, sodium edetate at a dose of 15 mg/kg b.w. under close monitoring of calcium levels and EKG. In the case of oligoanuria, hemodialysis (using calcium-free dialysate) is necessary. There is no specific antidote. It is recommended to monitor patients taking the drug in high doses for a long time to identify symptoms of a possible overdose (nausea, vomiting, diarrhea in the early phase, followed by constipation in the later phase, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, prolonged drowsiness, azotemia, polydipsia and polyuria). Side effectsPractically do not occur 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 D can occur. Symptoms of hypervitaminosis D: heart disorders: heart rhythm disturbances; disorders of the vascular system: hypertension; disorders of the nervous system: headache, lethargy; visual disturbances: conjunctivitis, photophobia; disorders of the gastrointestinal tract: loss of appetite, nausea, vomiting, constipation; disorders of the kidneys and urinary tract: uremia, polyuria; disorders of the musculoskeletal system and connective tissue: muscle and joint pain, muscle weakness; metabolic and nutritional disorders: increased blood cholesterol levels, weight loss, severe thirst, profuse sweating, pancreatitis; disorders of the liver and biliary tract: increased activity of aminotransferases; mental disorders: decreased libido, depression, mental disorders; general disorders and disorders at the injection site: itching; Rhinorrhea, hyperthermia, dry mouth, increased levels of calcium in the blood and / or urine, kidney stones and tissue calcification may also occur. Storage conditionsStore at a temperature not exceeding 25 °C. Store in original packaging to protect from light. Do not refrigerate, do not freeze. Keep out of the reach of children. Buy Aquadetrim drops for oral administration 15000 IU/ml 10ml No. 1