Composition, structure and packing
Drops for oral administration of 1 ml (30 drops). Kolekaltsiferol 15 thousand m
Excipients: kremofor EL, sucrose, sodium hydrophosphate, citric acid, anise flavor, benzyl alcohol, purified water.
Clinico-pharmacological group: The drug, which regulates the exchange of calcium and phosphorus.
The drug, which regulates the exchange of calcium and phosphorus. Vitamin D3 is an active antirahiticheskim factor. The most important function of vitamin D is to regulate the metabolism of calcium and phosphate, which promotes mineralization and growth of the skeleton.
Vitamin D3 is a natural form of vitamin D, which is formed in a person's skin under the action of sunlight. In comparison with vitamin D2 is characterized by a 25% higher activity.
Kolekaltsiferol plays a significant role in the absorption of calcium and phosphate in the intestine, transport of mineral salts and in the process of calcification of bones, also regulates the excretion of calcium and phosphate by the kidneys. The concentrations of calcium ions in the blood cause the maintenance of muscle tone of skeletal muscle, myocardial function, promote the holding of nerve impulses, regulate the process of blood clotting. Vitamin D is necessary for normal functioning of the parathyroid glands, is also involved in the functioning of the immune system, affecting the production of lymphokines.
Lack of vitamin D in food, a violation of his intake, calcium deficiency, and insufficient exposure to sunlight during the rapid growth of a child leads to rickets in adults - to osteomalacia in pregnant women may experience symptoms of tetany, disturbance of calcification of the bones of newborns.
Increased need for vitamin D occurs in women during menopause, because they often develop osteoporosis due to hormonal disorders.
The aqueous solution kolekaltsiferola absorbed better than oily solution (which is important when applying for premature babies, because the patched in this category of patients is a lack of education and the delivery of bile into the intestine, which violates the absorption of vitamins in the form of oil solutions). Once inside kolekaltsiferol absorbed from the small intestine.
Distribution and metabolism
Metabolised in the liver and kidneys. Penetrates through the placental barrier. Provided with breast milk. Kolekaltsiferol has the properties of cumulation.
T1 / 2 of a few days. Excreted in the urine and feces.
Pharmacokinetics in special clinical situations
In case of violation of renal function T1 / 2 may increase.
Prevention and treatment:
rickets and rahitopodobnyh diseases;
metabolic osteopathy (gipoparatireoz and psevdogipoparatireoz).
Treatment of osteoporosis, including postmenopauznogo (consisting of combined therapy).
Dose was set individually, taking into account the amount of vitamin D, which receives the patient in the diet and in the form of medicines. Drugs are taken in a spoonful of liquid (1 Cap. Kolekaltsiferola contains 500 IU). To tell you how dose vial should be kept at 45 °.
In order to prevent full-term infants with 3-4 weeks of life to 2-3 years with proper care and adequate exposure to the outdoors, a drug prescribed in a dose of 500-1000 IU (1-2 cap.) / Day.
Premature babies from 7 to 10 days of age, twins and children living in adverse conditions, prescribe 1000-1500 IU (2-3 cap.) / Day. During the summer months the dose can be reduced to 500 IU (1 cap.) / Day.
Pregnant women prescribed 500 IU daily (1 cap.) / Day for the entire period of pregnancy, or 1000 IU / day from 28 weeks of pregnancy.
In the period prescribed postmenopauznom 500-1000 IU (1-2 cap.) / Day.
When rickets medication prescribed daily dose of 2000-5000 IU (4-10 cap.) / Day for 4-6 weeks, depending on the severity of rickets and types of the course. It should monitor the patient's clinical condition and to investigate the biochemical parameters (levels of calcium, phosphorus, alkaline phosphatase activity in blood and urine). The initial dose is 2000 IU / day for 3-5 days, then good tolerability of the dose is increased to an individual treatment (usually up to 3000 IU / day). A dose of 5000 IU / day is assigned only when expressed by bone changes. If necessary, after 1 week break, the treatment can be repeated. Treatment should be continued to obtain a clear therapeutic effect, with the subsequent transition to a preventive dose of 500-1500 IU / day.
In the treatment of diseases rahitopodobnyh appoint 20 000-30 000 IU (40-60 Cap.) / Day depending on age, weight and severity of disease under control of biochemical indices of blood and urine analysis. The course of treatment - 4-6 weeks. In the treatment of osteoporosis postmenopauznogo (consisting of combined therapy) designate 500-1000 IU (1-2 cap.) / Day.
In applying the drug in recommended doses and the absence of individual sensitivity side effect is not revealed. In predisposed patients may experience symptoms of hypervitaminosis D: loss of appetite, nausea, vomiting, headache, muscle and joint pain, constipation, dry mouth, polyuria, depression, mental disorders, weight loss, increased levels of calcium in the blood and urine, formation of kidney stones, calcification of soft tissues.
formation of calcium kidney stones;
increased sensitivity to vitamin D3 and other components of the drug (especially benzyl alcohol).
Pregnancy and lactation
If pregnancy should not be used Akvadetrim in high doses because of possible manifestations of teratogenicity in the event of overdose.
Precautions should be appointed Akvadetrim during lactation, because when using the drug in high doses in nursing mothers may develop symptoms of an overdose in a child.
Application for violations of liver function
Kolekaltsiferol metabolized in the liver and kidneys.
Application for violations of renal function
In case of violation of renal function T1 / 2 may increase.
Be wary prescribers immobilized patients.
Use of the drug for medicinal purposes in children to be undertaken under close medical supervision and the correct dosing regimen during periodic surveys, especially in the first months of life.
In the appointment of the drug must be taken into account all possible sources of vitamin D. Prolonged use of Akvadetrima in high doses or use of the drug in doses of shock can lead to chronic hypervitaminosis D3. It should not be used simultaneously Akvadetrim and calcium in high doses.
Monitoring of laboratory parameters
In applying the drug for medicinal purposes should control the level of calcium in the blood and urine.
Symptoms: loss of appetite, nausea, vomiting, constipation, anxiety, thirst, polyuria, diarrhea, intestinal colic. Frequent symptoms are headache, muscle and joint pain, depression, mental disorders, ataxia, stupor, progressive loss of body weight. Developed renal failure with albuminuria, red blood cell and polyuria, increased loss of potassium, gipostenuriey, nocturia, and elevated blood pressure. In severe cases, possibly clouding of the cornea, less frequently - edema of the optic papilla, an inflammation of the iris until the development of cataracts. Perhaps the formation of kidney stones, calcification of soft tissues, including blood vessels, heart, lungs, skin.
Rarely develops cholestatic jaundice.
Treatment: you should stop using the product. Assign drinking large amounts of fluid.
If necessary, you may need hospitalization.
With simultaneous application Akvadetrima and thiazide diuretics increases the risk of hypercalcemia. With simultaneous application Akvadetrima with antiepileptic drugs, rifampicin, kolestiraminom absorption kolekaltsiferola reduced. The simultaneous use Akvadetrima with cardiac glycosides may enhance their toxic effects (increased risk of cardiac arrhythmias).
Terms and Conditions of storage
The drug should be stored in a dark place at temperatures from 5 ° to 15 ° C. Shelf life - 3 years.