Aqueous solution of vitamin D3 instructions for use. Instructions for the use of vitamin D3 - indications and dosage, which products contain and contraindications. Aquadetrim side effects
On the 1 ml:
Active substance: colcalciferol (vitamin D 3 ) - 0.375 * mg (15000 IU);
Excipients: macrogol glyceryl ricinoleate - 75,000 mg; sucrose (white sugar) - 250,000 mg; sodium hydrogen phosphate dodecahydrate - 7,000 mg; citric acid (citric acid monohydrate) - 0.430 mg; anethole - 0.825 mg; benzyl alcohol - 15,000 mg; water purified to 1 ml.
* 1 mg Colecalciferol corresponds to 40,000 IU of vitamin D 3 activity.
Description:Colorless, transparent or slightly opalescent liquid with a characteristic odor.
Pharmacotherapeutic group:Calcium-phosphorus metabolism regulator ATX:A.11.C.C.05 Colecalciferol
Pharmacodynamics:Vitamin D 3 is an active anti-rachitic factor. The most important function of vitamin D 3 is the regulation of calcium and phosphate metabolism, which promotes proper mineralization and skeletal growth.
Vitamin D 3 is the natural form of vitamin D that is produced in the human skin by exposure to sunlight. Compared to vitamin D 2 it is characterized by 25% higher activity. plays a significant role in the absorption of calcium and phosphate from the intestines, in the transport of mineral salts and in the process of bone calcification, 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, and is also involved in the functioning of the immune system, affecting the production of lymphokines.
Lack of vitamin D in food, impaired absorption, calcium deficiency, and insufficient exposure to sunlight leads: in children during a period of intensive growth - to rickets, in adults - to osteomalacia, in pregnant women symptoms of tetany may occur, in newborns - a violation processes of bone calcification. An increased need for vitamin D occurs in women during menopause due to the development of hormonal disorders leading to osteoporosis.
Pharmacokinetics:An aqueous solution of vitamin D 3 is absorbed better than an oil solution. In premature babies, there is insufficient formation and flow of bile into the intestines, which disrupts the absorption of vitamins in the form of oil solutions. After oral administration, it is absorbed in the small intestine. Metabolized in the liver and kidneys. The elimination 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. Vitamin D 3 has the property of cumulation. It is excreted from the body by the kidneys in a small amount, most of it is excreted in the bile.
Indications:Prevention of vitamin D deficiency and diseases associated with its deficiency (rickets, osteomalacia).
Rickets treatment.
Complex therapy of osteoporosis of various origins.
Contraindications:Hypersensitivity to the components of the drug, especially to benzyl alcohol.
Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Vitamin D hypervitaminosis.
Increased levels of calcium in the blood (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria), urolithiasis (formation of calcium oxalate stones), incl. in history, renal osteodystrophy with hyperphosphatemia, pseudohypoparathyroidism.
Sarcoidosis.
Acute and chronic diseases of the liver and kidneys, renal failure.
Active form of pulmonary tuberculosis.
Children's age up to 4 weeks of life.
Carefully:In patients who are in a state of immobilization.
In patients taking thiazide diuretics, as well as in patients with cardiovascular diseases taking cardiac glycosides (see section "Interaction with other drugs").
During pregnancy and breastfeeding (see section "Use during pregnancy and lactation").
In infants with a predisposition to early overgrowth of fontanelles (when small sizes of the anterior crown are established from birth).
When taking additional amounts of vitamin D and calcium (for example, as part of other drugs), in violation of urinary calcium and phosphate excretion, in the treatment of benzothiadiazine derivatives and in immobilized patients (risk of hypercalcemia and hypercalciuria) (see section " Special instructions").
In patients with the following concomitant diseases: atherosclerosis, heart failure, organic heart disease, granulomatosis, hyperphosphatemia, phosphate nephrourolithiasis, diseases of the gastrointestinal tract, peptic ulcer of the stomach and duodenum, hypothyroidism.
If you have one or more of the listed diseases and conditions, you should consult your doctor before taking the drug.
Pregnancy and lactation:During pregnancy, the drug should not be used in doses exceeding those recommended for the prevention of vitamin D deficiency (see section "Method of administration and doses"), due to the possibility of teratogenic effects in case of overdose.
Caution should be given to vitamin D 3 in women who are breastfeeding, because. a drug taken in high doses by the mother can cause overdose symptoms in the baby.
In the case of the use of the drug during pregnancy and during breastfeeding, it is necessary to take into account the intake of vitamin D from other sources, the daily dose of vitamin D should not exceed 600 IU.
Dosage and administration:Orally.
The drug Complivit® Aqua D 3 is taken orally in a spoonful of liquid.
1 drop contains about 500 IU of vitamin D 3 .
Prevention of rickets:
Full-term newborns from 4 weeks of life - 1 drop (500 IU) per day;
Premature babies from 4 weeks of age - 2 drops (1000 IU) per day during the first year of life, then 1 drop (500 IU) per day.
The drug should be used during the first two years of a child's life, during periods of low insolation (especially in winter).
Rickets treatment:
In the absence of visible deformations of the skeletal system (mild degree of rickets) - 2-3 drops (1000-1500 IU) per day, continue treatment for 30 days.
In the presence of deformations of the skeletal system characteristic of moderate and severe rickets - 4-8 drops (2000-4000 ME) per day, continue treatment for 30-45 days, the dose of the drug and the duration of therapy depend on the severity of the changes and are determined by the doctor ( cm. " Special instructions").
Prevention of vitamin D deficiency and diseases associated with its deficiency (osteomalacia):
1 drop (500 IU) per day during the entire period, accompanied by a deficiency in vitamin D intake. The minimum duration of the prophylaxis course is 1 month.
In the complex treatment of osteoporosis:
1-2 drops (500-1000 ME) per day for 3 months. Repeated courses of therapy are possible on the recommendation of a doctor, depending on the results of the assessment of markers of bone metabolism and calcium metabolism(see "Special Instructions"). Side effects:The frequency of adverse reactions has not been determined.
Metabolic and nutritional disorders:hypercalcemia and hypercalciuria.
Nervous system disorders: headache.
Cardiovascular disorders:increased blood pressure, arrhythmias.
Respiratory, thoracic and mediastinal disorders: exacerbation of the tuberculosis process in the lungs.
Gastrointestinal disorders:
loss of appetite, constipation, flatulence, nausea, abdominal pain or diarrhea.Skin and subcutaneous tissue disorders: hypersensitivity reactions such as itching, skin rash and urticaria.
Musculoskeletal and connective tissue disorders:arthralgia, myalgia.
Renal and urinary tract disorders:impaired renal function, polyuria.
If you experience side effects, you should consult a doctor.
Overdose:Symptoms of acute vitamin D overdose 3
early manifestations (due to hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, general weakness and fatigue, hypercalcemia, hypercalciuria, dehydration;
late manifestations
- bone pain, turbidity of urine (appearance of hyaline cylinders in the urine, proteinuria, leukocyturia), increased blood pressure, skin itching, eye photosensitivity, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss, rarely - psychosis (mental changes) and mood changes.Symptoms of Chronic Vitamin D Overdose 3 (when taken for several weeks or months for adults at doses of 20000-60000 IU / day, children - 2000-4000 IU / day): calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and chronic heart failure ( these effects most often occur when hyperphosphatemia is added to hypercalcemia), growth retardation in children (long-term use at a dose of 1800 IU / day).
Treatment. If the above symptoms appear, stop using the drug and consult a doctor. A diet low in calcium (for several weeks), consumption of large amounts of fluid, formed diuresis with the use of furosemide, electrolytes, as well as the appointment of glucocorticosteroids, calcitonin are shown. With proper kidney function, calcium levels can be significantly reduced by infusion of isotonic sodium chloride solution (3-6 liters over 24 hours) with the addition of furosemide and, in some cases, also sodium edetate at a dose of 15 mg/kg/h, while constant monitoring calcium levels and electrocardiogram data. In oligoanuria, on the contrary, hemodialysis (dialysate without calcium) is necessary. The specific antidote is unknown.
To prevent overdose, in some cases it is recommended to control the concentration of calcium in the blood.
Interaction:Antiepileptic drugs (especially and,) reduce the reabsorption of vitamin D 3.
The use simultaneously with hyazide diuretics increases the risk of hypercalcemia. In such cases, it is necessary to constantly monitor the concentration of calcium in the blood.
With hypervitaminosis D 3, it is possible to increase the action of cardiac glycosides and increase the risk of arrhythmias due to the development of hypercalcemia (it is advisable to control the concentration of calcium in the blood, electrocardiograms, as well as adjust the dose of cardiac glycoside).
Concomitant therapy with glucocorticosteroids may reduce the effectiveness of vitamin D 3 .
Long-term use of angacids containing aluminum and magnesium in combination with vitamin D 3 can increase the concentration of aluminum and magnesium in the blood and, as a result, the toxic effect of aluminum on bone tissue and hypermagnesemia in patients with renal insufficiency.
Colestyramine, colestipol and mineral oils reduce the absorption of fat-soluble vitamins from the gastrointestinal tract and require an increase in their dose.
The concomitant use of benzodiazepines increases the risk of hypercalcemia. Preparations containing high concentrations of calcium and phosphorus increase the risk of developing hyperphosphatemia.
When used simultaneously with sodium fluoride, the interval between doses should be at least 2 h; with oral forms of tetracyclines - at least 3 hours.
Simultaneous use with other analogues of vitamin D increases the risk of developing vitamin D hypervitaminosis.
Ketoconazole can inhibit both the biosynthesis and catabolism of 1,25(OH) 2 -colcalciferol.
Vitamin D is an antagonist of drugs used in hypercalcemia: etidronate, pamidronate, plikamycin, gallium nitrate.
Isoniazid and are able to reduce the effect of the drug due to an increase in the rate of biotransformation.
Vitamin D 3 does not interact with food.
Special instructions:Avoid overdose.
When taking the drug, the amount of vitamin D and calcium supplied with food and as part of other drugs should be taken into account.
Too high doses of vitamin D 3 used for a long time, or loading doses can be the cause of chronic hypervitaminosis D 3 .
High doses of calcium should not be used concomitantly with vitamin D3.
The drug should be used with caution in patients with impaired urinary calcium and phosphate excretion, in the treatment of benzothiadiazine derivatives and in immobilized patients (risk of hypercalcemia and hypercalciuria). In such patients, the level of calcium in the blood plasma and urine should be monitored.
Vitamin D 3 should not be taken in pseudohypoparathyroidism, as this disease may reduce the need for vitamin D, which may lead to the risk of long-term overdose.
The main clinical manifestations of mild rickets include nervous irritability, anxiety, shuddering at a sharp sound, a flash of light, sleep rhythm disturbances, superficial "anxious" sleep, sweating, skin itching, nape baldness, compliance of the edges of a large fontanel.
The presence of visible deformations of the bone tissue is typical for moderate and severe rickets, which, as a rule, require hospitalization and complex therapy prescribed by the doctor based on the results of the examination.
Repeated courses of therapy for osteoporosis are possible on the recommendation of a doctor, depending on the results of assessing markers of bone metabolism and calcium metabolism. If the doctor has prescribed a longer treatment than recommended in the instructions, then you should regularly (every three months of therapy) determine the level of calcium in the blood serum and urine, as well as assess kidney function by measuring the level of creatinine in the blood serum. If necessary, the dose can be adjusted by the doctor in accordance with the level of calcium in the blood serum.
In case of hypercalcemia or signs of impaired renal function, the dose of the drug should be reduced or treatment should be suspended. If the level of calcium in the urine exceeds 7.5 mmol / 24 h (300 mg / 24 h), it is recommended to reduce the dose of the drug or stop treatment.
Influence on the ability to drive transport. cf. and fur.:There are no data on the possible effect of the drug on the ability to drive vehicles and mechanisms.
Release form / dosage:Drops for oral administration, 15000 IU / ml. Package:10 ml in dark (amber) glass dropper bottles, sealed with polyethylene dropper caps and polyethylene caps with first opening control.
One dropper bottle, along with instructions for use, is placed in a cardboard box.
Storage conditions:In a place protected from light, at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Best before date:Do not use after the expiry date stated on the packaging.
Registration number:
Trade name of the drug: Aquadetrim
International non-proprietary name:
ColecalciferolDosage form:
drops for oral administration.Compound
1 ml solution (30 drops) contains:
active components.
Colecalciferol (Vitamin D 3) - 15,000 IU
Excipients. Macrogol glyceryl ricinoleate, sucrose, sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, anise flavor (or anise essence), benzine alcohol, purified water.
Description.
Colorless, clear or slightly opalescent liquid with an aniseed odour.
Pharmacotherapeutic group.
Calcium-phosphorus metabolism regulator.
ATX code: A 11 CC 05
Pharmachologic effect:
Vitamin D 3 is an active anti-rachitic factor. The most important function of vitamin D 3 is the regulation of calcium and phosphate metabolism, which promotes proper mineralization and skeletal growth.
Vitamin D 3 is the natural form of vitamin D that is produced in the human skin by exposure to sunlight. Compared to vitamin D2, it is characterized by a 25% higher activity. Colecalciferol 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 calcification of kosgei, 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, and is also involved in the functioning of the immune system, affecting the production of lymphokines.
Lack of vitamin D in food, violation of its absorption, calcium deficiency, as well as insufficient exposure to sunlight, during the period of intensive growth of the child, leads to rickets, in adults to osteomalacia; pregnant women may experience symptoms of tetany, a violation of the processes of calidification of the bone tissue of newborns. An increased need for vitamin D occurs in women during menopause, as they often develop osteoporosis due to hormonal disorders.
Pharmacokinetics.
An aqueous solution of vitamin D 3 is absorbed better than an oil solution. In premature babies, there is insufficient formation and flow of bile into the intestines, which disrupts the absorption of vitamins in the form of oil solutions. After oral administration, cholecalciferol is absorbed in the small intestine. Metabolized in the liver and kidneys. The half-life of colecalciferol from the blood is several days and may be prolonged in case of renal insufficiency. The drug crosses the placental barrier into the mother's milk. It is excreted from the body by the kidneys and through the intestines. Vitamin D 3 has the property of cumulation.
Indications for use
Prevention and treatment of vitamin D deficiency.Prevention and treatment of rickets, rickets-like diseases, hypocalcemic tetany, osteomalacia and metabolic-based bone diseases (such as hypoparathyroidism and pseudohypoparathyroidism).
In the complex treatment of osteoporosis, including postmenopausal.
Contraindications
Hypersensitivity to the components of the drug, especially to gasoline alcohol. Hypervitaminosis D, increased blood calcium concentration (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria), urolithiasis (formation of calcium oxalate stones), sarcoidosis, acute and chronic diseases of the liver and kidneys, kidney failure, active form of pulmonary tuberculosis. Children's age up to 4 weeks of life.Carefully: the state of immobilization, when taking thiazides, cardiac glycosides (especially digitalis glycosides); during pregnancy and breastfeeding.
In infants with a predisposition to early overgrowth of fontanelles (when small sizes of the anterior crown are established from birth).
Pregnancy and lactation
During pregnancy, vitamin D 3 should not be used in high doses due to the possibility of a teratogenic effect in case of an overdose.
Caution should be given to vitamin D 3 in women who are breastfeeding. The drug, taken in high doses by the mother, can cause overdose symptoms in the child.
During pregnancy and breastfeeding, the dose of vitamin D 3 should not exceed 600 IU per day
Dosage and administration
Orally.The drug is used in a spoonful of liquid.
1 drop contains about 500 IU of vitamin D 3 .
Unless the doctor prescribes otherwise, the drug is used in the following dosages:
Prophylactic doses:
- full-term newborns from 4 weeks of life, up to 2-3 years with proper care and sufficient exposure to fresh air: 500-1000 ME (1-drop) per day;
- premature babies, from 4 weeks of life, twins, babies in poor living conditions: 1000-1500 (2-3 drops) per day. In the summer, you can limit the dose to 500 ME (1 drop) per day.
- pregnant women: daily dose of 500 IU of vitamin D 3 for the entire period of pregnancy, or taking 1000 IU / day, starting from the 28th week of pregnancy.
- in the postmenopausal period 500-1000 ME (1-2 drops) per day.
Therapeutic doses:
- with rickets: daily 2000 - 5000 ME (4-10 drops), depending on the severity of rickets (I, II or III) and the variant of the course, for 4-6 weeks, under close monitoring of the clinical condition and the study of biochemical parameters (calcium, phosphorus , alkaline phosphatase) of blood and urine. You should start with 2000 ME for 3-5 days. Then, with good tolerance, the dose is increased to an individual therapeutic dose (most often 3000 IU). A dose of 5000 ME is prescribed only for severe bone changes.
As needed, after one week break, you can repeat the course of treatment.
Treatment is carried out until a clear therapeutic effect is obtained, followed by a transition to a prophylactic dose of 500 - 1500 IU / day. - in the treatment of rickets-like diseases: 20000-30000 ME per day (40-60 drops) depending on age, body weight and severity of the disease, under the control of blood biochemical parameters and urinalysis. The course of treatment is 4-6 weeks. Treatment is carried out under the supervision of a physician.
- in the complex treatment of postmenopausal osteoporosis: 500-1000 ME (1-2 drops) per day.
Side effect
Hypersensitivity to the components of the drug, hypervitaminosis D (symptoms of hypervitaminosis: loss of appetite, nausea, vomiting; headache, muscle and joint pain; constipation; dry mouth; polyuria; weakness; mental disorders, including depression; weight loss; impaired sleep; fever; protein, leukocytes, hyaline cylinders appear in the urine; an increase in the level of calcium in the blood and its excretion in the urine; calcification of the kidneys, blood vessels, and lungs is possible).If signs of hypervitaminosis D appear, it is necessary to cancel the drug, limit the intake of calcium, prescribe vitamins A, C and B.
Overdose
Overdose symptoms: loss of appetite, nausea, vomiting, constipation, anxiety, thirst, polyurethane, diarrhea, intestinal colic. Common symptoms are headache, muscle and joint pain, mental disturbances including depression, stupor, ataxia, and progressive weight loss. Kidney dysfunction develops with albinuria, erythrocyturia and polyuria, increased loss of potassium, hypostenuria, nocturia and increased blood pressure.
In severe cases, clouding of the cornea may occur, less often swelling of the papilla of the optic nerve, inflammation of the iris up to the development of cataracts.
Kidney stones can form, and soft tissues can calcify, including blood vessels, the heart, lungs, and skin.
Rarely develops cholestatic jaundice.
Treatment
Stop using the drug. Contact a doctor. Take plenty of fluids. Hospitalization may be required if necessary.
Interaction with other drugs
Antiepileptic drugs, rifampicin, cholestyramine reduce the reabsorption of vitamin D 3 .The use simultaneously with thiazide diuretics increases the risk of hypercalcemia.
Simultaneous use with cardiac glycosides may enhance their toxic effect (increased risk of manifestations of cardiac arrhythmias).
special instructions
Avoid overdose.
Individual provision of a specific need should take into account all possible sources of this vitamin.
Too high doses of vitamin D 3 used for a long time or loading doses can be the cause of chronic hypervitaminosis D 3 .
Determination of the child's daily requirement for vitamin D and the method of its use should be established by the doctor individually and each time subjected to correction during periodic examinations, especially in the first months of life.
Do not use simultaneously with vitamin D 3 high doses of calcium.
During treatment, periodic monitoring of the concentration of calcium and phosphates in the blood and urine is necessary.
Release form
Drops for oral administration 15,000 IU / ml. 10 ml or 15 ml in dark glass bottles with a polyethylene stopper-dropper and a polyethylene screw cap with a "first opening" guarantee ring. 1 bottle together with instructions for use is placed in a cardboard box.
Storage conditions
Store between 5 C and 25 C. Protect from light. Keep out of the reach of children.
Best before date 3 years.
Do not use after the expiration date.
Terms of dispensing from pharmacies
Without recipe.
Manufacturer
Medana Pharma Joint Stock Company98-200 Sieradz, st. Polish Organization Military 57, Poland
Organization accepting consumer claims
Joint Stock Company "Chemical and Pharmaceutical Plant "AKRIKHIN"
(JSC "AKRIKHIN"), Russia
142450, Moscow region, Noginsky district, Staraya Kupavna, st. Kirova, 29
Compound
1 ml 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.
Description
Colorless, clear or slightly opalescent liquid with an aniseed odour.
Pharmacotherapeutic group
Vitamin D (as cholecalciferol)
ATH code: A11 SS05
Pharmacological properties
Pharmacodynamics
Vitamin 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 intestines, 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.
Dosage 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 ME (1 drop) per day.
Vitamin Deficiency Treatment:
The dose of the drug is set by the doctor individually, depending on the state of vitamin deficiency.
Vitamin D-dependent rickets:
Children - from 3000 ME to 10 000 ME (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.
Side effect
Practically 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.
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.
Overdose
Vitamin D actively influences phosphorus-calcium metabolism, and its overdose leads to hypercalcemia, hypercalciuria, kidney calcification and bone damage, as well as 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.
Treatment for overdose
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 certain 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).
Precautions for use
The drug should be used according to the indicated dosage, care should be taken:
if the patient is immobile;
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.
Use 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.
Effects on ability to drive vehicles or servemechanisms
Does not affect.
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.
Package
Brown glass bottle with a capacity of 10 ml, sealed with a lid with a drip dispenser. 1 vial, together with the instruction leaflet, is placed in a cardboard box.
Manufacturer's name and address:
Medana Pharma JSC
98-200 Sieradz, st. V. Loketka 10
Release form: Liquid dosage forms. Drops for oral administration.
General characteristics. Compound:
The active substance is cholecalciferol 15,000 IU.
Excipients: macrogol glyceryl ricinoleate, sucrose (250 mg), sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, anise flavor, benzyl alcohol (15 mg), purified water.
Pharmacological properties:
Pharmacokinetics.
An aqueous solution of vitamin D3 is better absorbed than an oil solution (which is important when used in preterm infants). After oral administration, cholecalciferol absorption occurs in the small intestine by passive diffusion from 50 to 80% of the dose.Absorption - fast (in the distal small intestine), enters the lymphatic system, enters the liver and into the general circulation. In the blood, it binds to alpha2-globulins and partially to albumins. Accumulates in the liver, bones, skeletal muscles, kidneys, adrenal glands, myocardium, adipose tissue. TCmax (period of maximum concentration) in tissues is 4-5 hours, then the concentration of the drug decreases slightly, remaining at a constant level for a long time. In the form of polar metabolites, it is localized mainly in the membranes of cells and microsomes, mitochondria and nuclei. Penetrates through the placental barrier, excreted in breast milk.
Deposited in the liver.
It is metabolized in the liver and kidneys: in the liver it turns into an inactive metabolite calcifediol (25-dihydrocholecalciferol), in the kidneys it turns from calcifediol into an active metabolite calcitriol (1,25-dihydroxycholecalciferol) and an inactive metabolite 24,25-dihydroxycholecalciferol. It undergoes enterohepatic recirculation.
Vitamin D and its metabolites are excreted in the bile, a small amount - by the kidneys. Cumulates.
Pharmacodynamics.
Aquadetrim vitamin D3 is an anti-rachitic drug. The most important function of Aquadetrim vitamin D3 is the regulation of calcium and phosphate metabolism, which promotes mineralization and skeletal growth. Vitamin D3 is the natural form of vitamin D, which is produced in the human skin by exposure to sunlight. It 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 reabsorption of calcium and phosphate by the kidneys. Calcium ions are involved in a number of important biochemical processes that determine the maintenance of skeletal muscle tone, in the conduction of nervous excitation, and in the process of blood clotting. Aquadetrim vitamin D3 stimulates the production of lymphokines.Indications for use:
Prevention and treatment:
Hypocalcemic;
As part of complex therapy:
Dosage and administration:
The drug is taken orally with a small amount of liquid.
1 drop contains about 500 IU of vitamin D3.
Prophylactic doses:
Full-term newborns from 4 weeks of life to 2-3 years of life with proper care and sufficient exposure to fresh air - 500 IU (1 drop) per day;
Premature newborns from 4 weeks of life, as well as twins, babies in poor living conditions - 1000 IU (2 drops) per day for one year. In the summer, you can limit the dose to 500 IU (1 drop) per day. The duration of therapy is up to 2-3 years of life;
Pregnant women - a daily dose of 500 IU of vitamin D3 for the entire period of pregnancy, or 1000 IU / day from the 28th week of pregnancy;
Women in the postmenopausal period - 500 - 1000 IU (1-2 drops) per day, for 2-3 years, the doctor decides on the need for repeated courses of therapy.
Therapeutic doses:
For rickets, start with 2000 IU for 3-5 days, then, if well tolerated, increase the dose to an individual therapeutic dose of 2000-5000 IU (4-10 drops) daily, most often 3000 IU, depending on the severity of rickets (I, II , or III) and the variant of the course, for 4-6 weeks, under careful monitoring of the clinical condition and the study of biochemical parameters (calcium, phosphorus, alkaline phosphatase) of blood and urine. A dose of 5000 IU is prescribed only with pronounced bone changes.
As needed, after one week break, you can repeat the course of treatment. Treatment is carried out until a clear therapeutic effect is obtained, followed by a transition to a prophylactic dose of 500 - 1500 IU / day. The duration of the course of treatment and prevention is determined by the doctor.
With rickets-like diseases, 10,000 - 20,000 IU per day (20 - 40 drops), depending on the age, weight and severity of the disease, under the control of blood biochemical parameters and urinalysis. The course of treatment is 4-6 weeks. The doctor decides on the need for repeated courses of therapy.
With osteomalacia and postmenopausal osteoporosis as part of complex therapy, 500-1000 IU (1-2 drops) per day.
The dosage, as a rule, is prescribed taking into account the amount of vitamin D that comes from other foods.
Application Features:
Avoid overdose.
Individual provision of a specific need should take into account all possible sources of this vitamin.Too high doses of vitamin D3, used for a long time or loading doses, can be the cause of chronic hypervitaminosis D3.
Determination of the child's daily requirement for vitamin D and the method of its use should be established by the doctor individually and each time subjected to correction during periodic examinations, especially in the first months of life.
Use with caution in immobilized patients.
Do not use calcium preparations in high doses simultaneously with vitamin D3.Treatment is carried out under periodic monitoring of the level of calcium and phosphorus in the blood and urine.
Care must be taken when prescribing the drug to elderly people, since in this category of people calcium deposition in the lungs, kidneys and blood vessels increases.
Use with caution in patients with diabetes mellitus.
During pregnancy, Vitamin D3 should not be used in high doses of 2,000 IU due to the possibility of a teratogenic effect in case of an overdose.
Caution should be given to Vitamin D3 during lactation, as the drug, taken in high doses by the mother, can cause overdose symptoms in the child.On the ability to manage
vehicle or potentially dangerous machinery e influences.Side effects:
In the case of rarely noted individual hypersensitivity to vitamin D3 or as a result of the use of too high doses for a long period, hypervitaminosis D3 may occur:
Mental disorders, including;
loss of appetite, dry mouth, constipation;
Head, muscle and joint pain;
weight loss;
Increased calcium levels in the blood and urine;
Kidney stone formation and soft tissue calcification.
Interaction with other drugs:
Antiepileptic drugs, rifampicin, cholestyramine, reduce the reabsorption of vitamin D3.
The use simultaneously with thiazide diuretics increases the risk of hypercalcemia.
Simultaneous use with cardiac glycosides may enhance their toxic effect (increased risk of manifestations of cardiac arrhythmias).
The toxic effect is weakened by vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin.
Under the influence of barbiturates (including phenobarbital), phenytoin and primidone, the need for colecalciferol can increase significantly (increase the metabolic rate).
Long-term therapy against the background of the simultaneous use of aluminum and magnesium-containing antacids increases their concentration in the blood and the risk of intoxication (especially in the presence of chronic renal failure).
Calcitonin, derivatives of etidronic and pamidronic acids, plicamycin, gallium nitrate and glucocorticosteroids reduce the effect.
Colestyramine, colestipol and mineral oils reduce the absorption of fat-soluble vitamins from the gastrointestinal tract and require an increase in their dosage.
Increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia. When used simultaneously with sodium fluoride, the interval between doses should be at least 2 hours; with oral forms of tetracyclines - at least 3 hours.
Simultaneous use with other analogs of vitamin D increases the risk of developing hypervitaminosis.
Contraindications:
Hypersensitivity to the components of the drug, especially to benzyl alcohol;
Hypervitaminosis D;
Liver and kidney failure;
Increased levels of calcium and phosphorus in the blood and urine;
calcium kidney stones;
Neonatal period up to 4 weeks.
Overdose:
Symptoms: anxiety, thirst, loss of appetite, nausea, vomiting, diarrhea, constipation, polyuria. Common symptoms are headache, muscle and joint pain, mental disorders, including depression, stupor, and progressive weight loss. Kidney dysfunction develops with albinuria, erythrocyturia and polyuria, increased loss of potassium, hypostenuria, nocturia and increased blood pressure. In severe cases, it may occur, less often swelling of the papilla of the optic nerve, inflammation of the iris up to development. Kidney stones may form, and soft tissue calcification occurs, including blood vessels, the heart, lungs, and skin. Rarely develops cholestatic jaundice.
Treatment: withdrawal of the drug, drinking plenty of fluids, symptomatic therapy.
Storage conditions:
To store in the place protected from light at a temperature from 5 °C to 25 °C.
Keep out of the reach of children!
Leave conditions:
On prescription
Package:
10 ml in a dark glass bottle with a polyethylene stopper-dropper and a polyethylene screw cap with a “first opening” guarantee ring, together with instructions for medical use, in a cardboard box.