Description
Pharmacological action
An aqueous solution of vitamin D3 is better absorbed than an oil solution. In premature infants, there is insufficient formation and entry of bile into the intestine, which disrupts the absorption of vitamins in the form of oil solutions.
After oral administration, colecalciferol is absorbed in the small intestine. Metabolized in the liver and kidneys. The half-life of colecalciferol from the blood is several days and can last in case of renal failure. The drug crosses the placental barrier and into the mother’s milk.
It is excreted by the kidneys in a small amount, most of it is excreted in the bile. Vitamin D3 has the property of cumulation.
Indications
– Prevention and treatment of vitamin D deficiency.
– Prevention and treatment of rickets.
– In the complex treatment of osteoporosis, including postmenopausal.
Contraindications
Hypersensitivity to the components of the drug. Hypervitaminosis D, an increased concentration of calcium in the blood (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria), urolithiasis (the formation of calcium oxalate stones), sarcoidosis, acute and chronic diseases of the liver and kidneys, renal failure, an active form of pulmonary tuberculosis, pseudohypoparathyroidism, sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Precautions: immobilization state, atherosclerosis, during pregnancy and breastfeeding.
In patients taking thiazide diuretics, as well as in patients with cardiovascular diseases taking cardiac glycosides.
In infants with a predisposition to the early overgrowth of fontanelles (when small sizes of the anterior temples are established from birth).
Special instructions
Avoid overdosing. Individual provision of a specific need should take into account all possible sources of this vitamin. Too high doses of vitamin D3, used continuously or in shock doses, can cause chronic hypervitaminosis D3.
The determination of a child’s daily requirement for vitamin D and the method of its use should be determined individually by a doctor and each time subjected to correction during periodic examinations, especially in the first months of life.
When an adequate level of vitamin D concentration in the blood is reached (> 30 ng / ml 25 (OH) D) in adults, it is possible to continue maintenance therapy with Aquadetrim at a dose of 1500-2000 ME (3-4 tablets) per day.
In the absence of water, the tablet can be dissolved in the mouth.
Do not use high doses of calcium simultaneously with vitamin D3.
During treatment, periodic monitoring of the concentration of phosphates in the blood and urine is necessary.
With long-term use of colecalciferol, it is necessary to regularly determine the level of calcium in blood serum and urine, as well as to assess kidney function by measuring serum creatinine. If necessary, the dose of colecalciferol should be adjusted depending on the level of calcium in the blood serum.
Composition of
Tablets – 1 tablet:
Active ingredient:
Vitamin D3 100SD / S dry -5 mg (corresponds to 500 IU colecalciferol).
Excipients: d, l-alpha-tocopherol, modified starch, sucrose, crystalline sodium ascorbate, medium chain triglycerides, silicon dioxide, mannitol, sodium benzoate.
Dosage and Administration
Inside.
Dissolve the tablet in water at room temperature (at least 15 ml of water – 1 tablespoon). Dissolution of the tablet takes some time (about 1-2 minutes). Unless otherwise prescribed by the doctor, the drug is used in the following dosages:
Prophylactic doses:
Full-term newborns from 4 weeks of life to 2-3 years with proper care and sufficient exposure to fresh air: 500 ME (1 tablet) per day.
Premature babies from 4 weeks of age, twins, babies, being in poor living conditions: 1000-1500 ME (2-3 tablets) per day.
In the summer, you can limit the dose to 500 ME (1 tablet) per day.
in healthy adults without malabsorption: 500 ME (1 tablet) per day, in adult patients with malabsorption syndrome: 3000-5000 ME (6-10 tablets) per day (except for patients with glucose-galactose malabsorption).
pregnant women: a daily dose of 500 ME (1 tablet) of vitamin D3 for the entire period of pregnancy, or 1000 ME (2 tablets) per day, starting from the 28th week of pregnancy.
In the postmenopausal period, 500-1000 ME (1-2 tablets) per day.
Therapeutic doses:
For rickets: daily 1000-5000 ME (2-10 tablets), depending on the severity of rickets (I, II, or III) and the course, for 4-6 weeks, under close monitoring of the clinical condition and study of biochemical parameters (calcium, phosphorus, alkaline phosphatase) of blood and urine. Begin with 1000 ME for 3-5 days. Then, with good tolerance, the dose is increased to an individual therapeutic dose (most often 3000 ME). A dose of 5000 ME is prescribed only for severe bone changes.
If necessary, 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 ME per day.
In the complex treatment of postmenopausal osteoporosis: 500-1000 ME (1-2 tablets) per day.
To maintain an adequate level of concentration of vitamin D in the blood (> 30 ng / ml 25 (OH) D) – 2000 ME (4 tablets) per day.
dosage is usually assigned based on the amount of vitamin D that comes with food.
Side effects
Hypersensitivity to the drug, hypervitaminosis D (symptoms of hypervitaminosis: loss of appetite, nausea, vomiting headaches, muscle and joint pain, constipation, dry mouth, polyuria, weakness, mental illness, including depression, weight loss, sleep disturbance, 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 is possible calcification of the kidneys, blood vessels, lungs).
When signs of hypervitaminosis D appear, the drug must be discontinued, calcium intake limited, vitamins A, C and B. prescribed.
Overdose
Overdose symptoms: loss of appetite, nausea, vomiting, constipation, anxiety, thirst, polyuria, diarrhea, intestinal colic. Common symptoms are headache, muscle and joint pain, mental disorders, including depression, stupor, ataxia, and progressive weight loss. Renal dysfunction develops with albuminuria, erythrocyturia and polyuria, increased potassium loss, hypostenuria, nocturia and increased blood pressure.
In severe cases, clouding of the cornea may occur, less often swelling of the optic papilla, inflammation of the iris up to the development of cataracts. Kidney stones may form, and calcification of soft tissues, including blood vessels, heart, lungs, and skin, occurs. Cholestatic jaundice rarely develops.
Treatment: Discontinue use of the drug. See a doctor. Take plenty of fluids. If necessary, hospitalization may be required.
Active ingredient
Colecalciferol
Terms of pharmacy leave
Over-the-counter
lekarstvennaja tablet form
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