DeTriFerol
DeTriFerol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Detriferol
ATX code: A11CC05
Active ingredient: colecalciferol (Colecalciferol)
Manufacturer: LLC "Grotex" (Russia)
Description and photo update: 2019-11-07
Prices in pharmacies: from 186 rubles.
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DeTriFerol - vitamin D.
Release form and composition
Dosage form of the drug - drops for oral administration: slightly opalescent or transparent liquid, slightly colored or colorless, with a characteristic odor (10, 15, 20, 25 or 30 ml each in dark glass bottles equipped with a dropper stopper and a screw cap with a protection mechanism from children or without it, the cardboard box contains 1 bottle and instructions for the use of DeTriFerol).
Composition of 1 ml of the preparation:
- active substance: colecalciferol - 0.375 mg, or 15,000 IU (International units);
- auxiliary components: water for injection, sodium saccharinate, macrogol glyceryl hydroxystearate, propylene glycol, sodium hydrogen phosphate dihydrate, anhydrous citric acid, methyl parahydroxybenzoate, anise flavor.
Pharmacological properties
Pharmacodynamics
Colecalciferol (Vitamin D 3) is a natural form of Vitamin D that is produced in humans in the skin by exposure to sunlight. It has 25% higher activity than vitamin D 2.
Vitamin D 3 is an important antirachitic factor. Its most important function is to regulate calcium and phosphate metabolism, which is necessary for proper mineralization and skeletal growth.
The drug plays a significant role in the absorption of calcium and phosphates in the intestine, in the transport of mineral salts and in the process of bone calcification. It also regulates the excretion of phosphate and calcium by the kidneys.
With the required level of calcium ions in the blood, the tone of the muscles of the skeletal muscles and the function of the myocardium are maintained, the conduction of nervous excitement is ensured, and the process of blood coagulation is regulated.
With insufficient intake of vitamin D from food or a violation of its absorption, with a calcium deficiency or insufficient exposure of the child to the sun during the period of rapid growth, rickets develops. In adults, these factors contribute to the development of osteomalacia, in pregnant women - the onset of symptoms of tetany, disruption of the processes of calcification of the bones of newborns.
The need for cholecalciferol increases during the menopause of a woman, which is due to an increased risk of osteoporosis due to hormonal disorders.
Vitamin D has some so-called off-skeletal effects. By modulating cytokine levels, it participates in the functioning of the immune system. Regulates differentiation of B-lymphocytes and division of T-helper lymphocytes. In separate studies, patients receiving vitamin D have shown a decrease in the incidence of respiratory tract infections.
It has been established that vitamin D is an important link in the homeostasis of the immune system, since it prevents the development of autoimmune diseases, including rheumatoid arthritis, multiple sclerosis, type I diabetes mellitus, and inflammatory bowel diseases. It has differentiating and antiproliferative properties, which determine its oncoprotective effect. It has been found that in patients with low blood levels of this vitamin, the incidence of certain tumors (for example, colon cancer and breast cancer) increases.
Vitamin D is a participant in carbohydrate and fat metabolism, which is due to its effect on the synthesis of the substrate of the insulin receptor IRS1 (participates in the intracellular pathways of the insulin receptor signal), insulin-like growth factor IGF (regulates the balance of adipose and muscle tissue), activated peroxisome proliferator receptor PPAR-5 (promotes the processing of excess cholesterol).
According to epidemiological studies, a lack of vitamin D can cause metabolic disorders (metabolic syndrome, type II diabetes mellitus). Metabolizing enzymes and vitamin D receptors are expressed in the heart, arterial vessels, as well as practically in all tissues and cells of the body that are related to the pathogenesis of diseases of the cardiovascular system. In animal models, renin suppression, antiatherosclerotic action, and prevention of myocardial damage have been demonstrated. Low vitamin D content is associated with such negative risk factors for the development of cardiovascular pathology as arterial hypertension, dyslipidemia, diabetes mellitus. They can lead to serious complications, including stroke.
According to research data on experimental models of Alzheimer's disease, vitamin D 3 reduces the accumulation of amyloid in the brain and improves cognitive function. In non-interventional studies in humans, it has been shown that the incidence of dementia and Alzheimer's disease increases with low vitamin D levels and low dietary intake. At low levels of this vitamin, cognitive decline and an increase in the incidence of Alzheimer's disease have been reported.
Pharmacokinetics
An aqueous solution of colecalciferol is absorbed better than an oil solution, which is especially important for the treatment of premature babies (they have a lack of production and flow of bile into the intestines, which is why the absorption of oil solutions is impaired).
After oral administration, DeTriFerol is rapidly absorbed in the distal small intestine, enters the lymphatic system, enters the liver and the general bloodstream, where it binds to a2-globulins, to a lesser extent to albumin. Accumulates in the liver, adrenal glands and kidneys, skeletal muscles and bones, adipose tissue, myocardium. Penetrates through the placental barrier and into breast milk.
After 4-5 hours after ingestion, it reaches its maximum concentration (C max). Subsequently, the content in the blood decreases slightly and remains at a constant level for a long time.
Metabolized in the liver and kidneys. In the liver, colecalciferol is biotransformed into calcifediol (25-dihydrocolecalciferol), which does not possess pharmacological activity, in turn, calcifediol in the kidneys is converted into an active metabolite calcitriol (1,25-dihydroxycolecalciferol) and inactive 24,25-dihydroxycolciferol. Colecalciferol undergoes enterohepatic recirculation.
It is excreted mainly with bile through the intestines, in small quantities - by the kidneys.
Indications for use
- prevention of vitamin D deficiency and diseases associated with its deficiency, such as rickets and osteomalacia;
- rickets treatment;
- therapy of osteoporosis of various origins (as part of complex therapy).
Contraindications
Absolute:
- hypervitaminosis of vitamin D;
- acute and chronic liver diseases;
- sarcoidosis;
- active form of pulmonary tuberculosis;
- renal failure, acute and chronic kidney disease;
- renal osteodystrophy with hyperphosphatemia;
- urolithiasis (the formation of calcium oxalate stones);
- increased excretion of calcium in the urine (hypercalciuria);
- hypercalcemia (increased concentration of calcium in the blood);
- pseudohypoparathyroidism;
- children up to 4 weeks old;
- hypersensitivity to any component of the drug.
Relative (DETRIFEROL drops 15,000 IU / ml are used with caution):
- pregnancy and the period of breastfeeding;
- the presence of concomitant diseases such as hypothyroidism, diseases of the gastrointestinal tract, phosphate nephrourolithiasis, gastric ulcer and duodenal ulcer, organic heart disease, heart failure, atherosclerosis, hyperphosphatemia, granulomatosis;
- the presence in the infant of a predisposition to early overgrowth of the fontanelle (from birth, the small size of the anterior crown is established);
- violation of the excretion of calcium and phosphate in the urine;
- prolonged immobilization;
- simultaneous administration of thiazide diuretics to patients receiving cardiac glycosides;
- joint use of benzothiadiazine derivatives;
- additional intake of vitamin D and calcium (for example, as part of other drugs).
DeTriFerol, instructions for use: method and dosage
DeTriFerol drops should be taken orally, having previously dripped into a spoonful of drinking water.
Recommended dosage regimens:
- prevention of rickets in full-term newborns from the fourth week of life: 1 drop 1 time per day in the first 2 years of a child's life during periods of low insolation (especially in winter);
- prevention of rickets in premature newborns from the fourth week of life: 2 drops per day during the first year of life, during the second year of life (during periods of low insolation, especially in winter) - 1 drop 1 time per day;
- treatment of rickets: mild (no visible deformities of the bones) - 2-3 drops per day for a course of 30 days, moderate and severe (in the presence of deformities of the skeletal system) - 4-8 drops per day for 30-45 days (optimal the dose and duration of therapy is determined by the doctor depending on the severity of the changes);
- prevention of vitamin D deficiency and osteomalacia: 1 drop per day during the entire period of vitamin D deficiency, but not less than 1 month;
- complex therapy of osteoporosis: 1-2 drops per day for a course of 3 months. If necessary (depending on the results of the assessment of markers of calcium and bone metabolism), the doctor may recommend repeated courses.
1 drop contains approximately 500 IU of vitamin D 3.
Side effects
- from the side of the heart and blood vessels: arrhythmias, increased blood pressure;
- from the nervous system: headache;
- from the gastrointestinal tract: abdominal pain, flatulence, diarrhea / constipation, nausea;
- from the side of metabolism and nutrition: decreased appetite, hypercalciuria, hypercalcemia;
- from the kidneys, urinary tract: functional impairment of the kidneys, polyuria;
- from the respiratory system: exacerbation of the tuberculous process in the lungs;
- on the part of the connective and musculoskeletal tissue: myalgia, arthralgia;
- on the part of the skin and subcutaneous tissues: hypersensitivity reactions (itching, skin rashes, urticaria).
The exact incidence of adverse reactions has not been determined.
Overdose
Symptoms of an acute vitamin D 3 overdose:
- early signs (due to an increase in the concentration of calcium in the blood plasma): general weakness, fatigue, metallic taste in the mouth, thirst, dryness of the oral mucosa, diarrhea or constipation, nausea, anorexia, vomiting, dehydration, hypercalciuria, hypercalcemia, nocturia, pollakiuria, polyuria, headache;
- late signs: conjunctival hyperemia, eye photosensitivity, drowsiness, arrhythmia, increased blood pressure, myalgia, pruritus, clouding of urine (appearance of hyaline casts in the urine, leukocyturia, proteinuria), bone pain, nausea, vomiting, gastralgia, weight loss, pancreatitis; rarely - changes in mood and psyche.
Manifestations of chronic overdose occur with long-term (over several weeks and months) intake of DeTriFerol in high daily doses (20,000-60,000 IU for adults, 2,000-4,000 IU for children). Growth disorders are possible in children. Mainly with the development of hyperphosphatemia against the background of hypercalcemia, arterial hypertension, calcification of the blood vessels, lungs, kidneys and soft tissues, renal and chronic heart failure occur.
If symptoms of an overdose of DeTriFerol develop, it should be discontinued and a doctor should be consulted. The patient should follow a low calcium diet and drink plenty of fluids for several weeks.
Cholecalciferol has no specific antidote. Therapeutic measures are forced diuresis with the use of furosemide and electrolytes, the appointment of calcitonin and glucocorticosteroids.
With normal renal function, the plasma calcium concentration can be significantly reduced by infusion of isotonic sodium chloride solution (3–6 liters for 24 hours) with the addition of furosemide, in some cases - with the addition of sodium edetate (15 mg / kg / h). Careful monitoring of plasma calcium levels and monitoring of electrocardiogram indicators are required. In the case of oligoanuria, on the contrary, hemodialysis (without calcium) is performed.
special instructions
The main symptoms of mild rickets in children are: startling with a sharp sound and flash of light, superficial anxious sleep, sleep disturbances, anxiety, nervous irritability, nape baldness, itching of the skin, sweating, suppleness of the edges of the large fontanelle.
For moderate and severe rickets, visible deformities of the bone tissue are characteristic. In most cases, they require hospitalization, a complete examination and appropriate complex therapy.
To avoid overdose, you should not yourself exceed the recommended doses of DeTriFerol. Some patients may want to monitor the concentration of calcium in the blood.
During the period of therapy, it is important to take into account the intake of vitamin D and calcium from other sources - food and other medicines.
Shock doses of cholecalciferol or too high doses taken for a long time can cause the development of chronic vitamin D 3 hypervitaminosis.
When DeTriFerol is prescribed to patients who have impaired excretion of calcium and phosphates in the urine, immobilized individuals and patients receiving benzothiadiazine derivatives have an increased risk of developing hypercalcemia and hypercalciuria. Therefore, it is required to control the concentration of calcium in plasma and urine.
DeTriFerol is contraindicated in pseudohypoparathyroidism, since in this disease the need for vitamin D 3 is often reduced, and taking the drug can cause chronic overdose.
With the development of hypercalcemia (the concentration of calcium in the urine is more than 7.5 mmol / 24 h, or 300 mg / 24 h), as well as the appearance of symptoms of functional impairment of the kidneys, the dose of DeTriFerol should be reduced or treatment should be stopped.
The attending physician may recommend repeated courses for osteoporosis, if there is a reason for this based on the results of an assessment of markers of calcium and bone metabolism. With long-term treatment (exceeding that recommended in the instructions for DeTriFerol), it is necessary to regularly monitor the content of creatinine in the blood serum, the concentration of calcium in the urine and blood serum. If necessary, the dose of the drug should be adjusted.
Influence on the ability to drive vehicles and complex mechanisms
There is no information on the negative effect of DeTriFerol on human functions, on which the speed of reactions and the ability to concentrate depend.
Application during pregnancy and lactation
In case of an overdose of vitamin D during pregnancy, there is a risk of developing a teratogenic effect of the drug. Therefore, DeTriFerol in women during gestation is used in doses recommended for the prevention of vitamin D deficiency.
During lactation, DeTriFerol should be used with caution, not exceeding the dose prescribed by your doctor. Excess doses are fraught with the development of symptoms of cholecalciferol overdose in an infant.
Pregnant and breastfeeding women should not exceed a daily dose of 600 IU. In this case, it is imperative to take into account the intake of vitamin D and calcium from other sources, including food and other drugs.
Pediatric use
DeTriFerol is prescribed to children (including premature babies) from the age of 4 weeks.
If the infant has a predisposition to early overgrowth of the fontanelle (the small size of the anterior crown is established from birth), care must be taken when taking DeTriFerol.
With impaired renal function
The drug is contraindicated in renal failure, chronic and acute kidney disease.
For violations of liver function
DeTriFerol is contraindicated in chronic and acute liver diseases.
Use in the elderly
There are no data on the need to adjust the dose of DeTriFerol for elderly patients.
Drug interactions
- glucocorticosteroids: it is possible to reduce the effect of cholecalciferol;
- aluminum- or magnesium-containing antacids: colecalciferol with long-term combined use with antacids can increase the content of aluminum / magnesium in the blood, which is fraught with the toxic effect of aluminum on bone tissue or the development of hypermagnesemia in patients with renal insufficiency;
- ketoconazole: biosynthesis and catabolism of 1,25 (OH) 2-colecalciferol may be inhibited;
- drugs used for hypercalcemia (pamidronate, etidronate, plikamycin, calcitonin, gallium nitrate): vitamin D is their antagonist;
- thiazide diuretics: the risk of hypercalcemia increases (it is required to control the level of calcium in the blood);
- rifampicin, isoniazid: reduce the effect of DeTriFerol due to an increase in the rate of biotransformation;
- cholestyramine, rifampicin and antiepileptic drugs (especially primidone, phenobarbital and phenytoin): the reabsorption of vitamin D 3 decreases;
- preparations containing high concentrations of calcium and phosphorus: the risk of developing hyperphosphatemia increases;
- benzodiazepines: the risk of hypercalcemia increases;
- mineral oils, colestipol, cholestyramine: absorption of colecalciferol in the gastrointestinal tract decreases, which requires an increase in the dose of DeTriFerol;
- cardiac glycosides: with hypervitaminosis of vitamin D 3, their effect may be enhanced, which entails the risk of arrhythmias against the background of hypercalcemia (it is necessary to adjust the dose of cardiac glycosides, control the level of calcium in the blood and electrocardiogram indicators);
- other vitamin D analogues: increases the likelihood of developing vitamin D hypervitaminosis.
Vitamin D 3 does not interact with food.
If necessary, the simultaneous use of oral forms of tetracyclines between doses of drugs should be observed at least 3-hour intervals. With the joint appointment of sodium fluoride, the interval between doses should be at least 2 hours.
Analogs
DeTriFerol analogs are Aquadetrim, Vigantol, Vitamin D3, D3-Droplet, Complivit Aqua D 3, etc.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C out of reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews about DeTriFerol
There are no reviews directly about DeTriFerol on social networks and on specialized medical forums, since the drug has recently appeared on the pharmaceutical market. However, reviews of preparations containing colecalciferol are positive. They are successfully used in pediatrics and are well tolerated.
The price of DeTriFerol in pharmacies
Depending on the region of sale and the pharmacy network, the price for DeTriFerol 15,000 IU / ml is approximately 180 rubles. for 1 bottle of 15 ml.
DeTriFerol: prices in online pharmacies
Drug name Price Pharmacy |
Detriferol 150000 IU / ml drops for oral administration with anise aroma 15 ml 1 pc. RUB 186 Buy |
Detriferol 150,000 IU / ml drops for oral administration with banana aroma 15 ml 1 pc. 189 r Buy |
Detriferol drops for internal approx. 15000 IU / ml vial 15ml 198 RUB Buy |
Detriferol oral drops 15000 IU / ml 15ml bottle (banana flavor) 198 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!