Ergocalciferol (Vitamin D2) solution in oil 0.0625% (Ergocalciferol (vitamin D2) solution in oleum 0.0625%)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceErgocalciferolErgocalciferol
Dosage form: & nbspdrops for oral administration [in oil]
Composition:

Active components

Ergocalciferol - 625 mg

Excipients

Soya beans refined deodorized oil up to 1 liter

A solution of ergocalciferol (vitamin D2) in oil contains in 1 ml 25000 ME. One drop of a solution of ergocalciferol (vitamin D2) in oil from an eye dropper or from a dropper contains about 700 ME.

Description:

Transparent oily liquid from light yellow to dark yellow color, without rancid smell.

Pharmacotherapeutic group:vitamin - calcium-phosphorus exchange regulator
ATX: & nbsp

A.11.C.C   Vitamin D and its derivatives

A.11.C.C.01   Ergocalciferol

Pharmacodynamics:

Vitamin D2 regulates the exchange of calcium and phosphorus in the body, accelerates the absorption of calcium in the intestines, improves the reabsorption of calcium and phosphorus in the kidneys, maintains the necessary level of these elements in the blood, promotes the formation of the skeleton in children, and also preserves the structure of the bones.

Vitamin D2 It is also necessary for the manifestation of the physiological effect of a number of thyroid stimulating hormones and thyrecalciotonin.

Lack of vitamin D2 in young children causes disease of rickets.

Vitamin D2 possesses a cumulative property.

Indications:

Vitamin D2 are used for the prevention and treatment of rickets and rachitis-like diseases in children with osteopathy of different genesis, with D hypovitaminosis in pregnant women, in patients with orthopedic pathology (osteoporosis) or delayed consolidation of fractures.

Contraindications:

Hypersensitivity to the drug components, hypercalcemia, hypervitaminosis D, renal osteodystrophy with hyperphosphataemia.

Carefully:

atherosclerosis, old age (can contribute to the development of atherosclerosis), pulmonary tuberculosis (active form), sarcoidosis or other granulomatosis, chronic heart failure, pregnancy (in women over 35 years), lactation period, children's age.

Dosing and Administration:

The drug is taken orally.

Pregnant women should take the drug, starting from 30-32 weeks of pregnancy before delivery every day for 700 ME (one drop) per day.

Pregnant children for the prevention of rickets vitamin D2 appointed from 3 weeks of age to 700 ME vitamin D2 (one drop) every other day for the entire first year, except for the summer months. The average annual dose for a year is not more than 150,000 ME.

Preterm infants and children in unfavorable conditions of life, vitamin D2 appoint from 8-10 days of age to 700 ME (one drop) daily for a year. The total dose is not more than 250,000-300,000 ME in year.

In the treatment of rickets of 1 degree, children are given daily 2,800 ME (4 drops) of vitamin D2 within 45-60 days. Total for the course of treatment is appointed no more than 150000-200000 ME vitamin D2

In the treatment of rickets of 2-3 degrees, a course of treatment is prescribed for 4900-9800 ME (7-14 drops) of vitamin D2 per day for 60 days. The course dose is not more than 300,000-600,000 ME. In the case of an exacerbation or relapse of rickets, a second course of treatment is recommended, but not earlier than 2 months after the end of the first course.

With rachitis-like diseases, the treatment dose is selected by the doctor individually for each patient. For the treatment of patients with orthopedic pathology (osteoporosis) it is recommended to take 2800-4900 ME (4-7 drops) of vitamin D2 per day for 30 days, a second course after 3 months.

Side effects:

Allergic reactions.

Overdose:

Symptoms of vitamin D hypervitaminosis2: early (Due to hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anareksiya, metallic taste in the mouth, nausea, vomiting, unusual tiredness, asthenia, hypercalcemia, hypercalcuria; later - pain in the bones, clouding of urine, (appearance of hyaline cylinders, proteinuria, leukocyturia in the urine), high blood pressure, itchy skin, eye photosensitivity, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, slimming, rarely - a change in mood and psyche (up to the development of psychosis).

Symptoms of chronic intoxication with vitamin D2 (At reception for several weeks or months to adults in doses of 20-60 thousand IU / day for children 2-4-thousand IU / day..); calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and cardiovascular insufficiency up to the fatal outcome (these effects occur most often with adherence to hypercalcemia, hyperphosphataemia), growth impairment in children (prolonged use at a dose of 1.8 thousand IU / day).

Treatment: when there is evidence of hypervitaminosis D, it is necessary to cancel the drug, to limit the intake of calcium, to prescribe vitamins A, C and B.

Interaction:

Toxic effect weakens vitamin A, vitamin E, ascorbic acid, pantothenic acid, thiamine, riboflavin, pyridoxine.

Thiazide diuretics, calcium-containing drugs increase the risk of hypercalcemia (they require monitoring of the concentration of calcium in the blood E

In hypervitaminosis caused by the use of ergocalciferol, may increase the action of cardiac glycosides and increased risk of arrhythmia, caused by the development of hypercalcemia (expedient correction doses of cardiac glycosides).

Under the influence of barbiturates (including phenobarbital), phenytoin, primidone ergocalciferol need may considerably increase, resulting in amplification osteomalacia or severity of rickets (due to acceleration ergocalciferol metabolism to inactive metabolites due to induction of microsomal enzymes).

Long-term therapy against the background of simultaneous use of antacids containing ions of aluminum and magnesium, increases their concentration in the blood and the risk of intoxication (especially in the presence of chronic kidney failure).

Calcitonin, derivatives of etidronic and pamidronic acids, plikamycin, gallium nitrate and glucocorticosteroid drugs reduce the effect.

Kolestyramin, colestipol and mineral oils reduce the absorption in the gastrointestinal tract of fat-soluble vitamins and require an increase in their dosage.

Increases the absorption of phosphorus-containing drugs and the risk of hyperphosphataemia.

Simultaneous application with other analogues of vitamin D2 (especially calcipediol) increases the risk of hypervitaminosis.

Special instructions:

Preparations of vitamin D2 stored in conditions that exclude the effects of light and air, inactivating them: oxygen oxidizes vitamin D2, and light turns it into toxic toxifier.

It should be borne in mind that vitamin D2 possesses cumulative properties. With prolonged use it is necessary to determine the concentration of calcium in the blood and urine. When treating large doses of ergocalciferol, simultaneous intake of vitamin A at 10-15 thousand IU / day, as well as ascorbic acid and B vitamins is recommended.

When ergocalciferol is prescribed for premature infants, it is advisable to administer phosphate simultaneously.

It should be borne in mind that the sensitivity to vitamin D2 in different patients it is individual and in a number of patients the administration of even therapeutic doses can cause the phenomenon of hypervitaminosis.

Sensitivity of newborns to vitamin D2 can be different, some of them can be sensitive even to very low doses. Children receiving vitamin D2 in a dose of more than 1800 ME for a long period of time, the risk of growth retardation increases.

For the prevention of hypovitaminosis, most preferably a balanced diet.

Newborns who are breastfed, especially mothers with dark skin and / or who are deficient in insolation, have a high risk of vitamin D deficiency2.

Ergocalciferol is not recommended for family hypophosphatemia and hypoparathyrosis due to the need for high doses and the high risk of overdose (these nosologies are most preferred dihydrotachysterol and calcitriol).

Hypercalcemia in the mother (associated with a prolonged overdose of vitamin D2 during pregnancy) can cause the fetus to increase the sensitivity to vitamin D2, suppression of parathyroid function, syndrome of specific elf-like appearance, mental retardation, aortic stenosis.

In old age, the need for vitamin D2 may increase as a result of decreased absorption of vitamin D2, reducing the ability of the skin to synthesize provitamin D3, reducing the time of insolation, increasing the incidence of renal failure.

With prolonged use of therapeutic doses (more than 20 days), it is necessary to make a study of calcium and phosphorus in the blood and urine.

Form release / dosage:

Drops for oral administration [in oil] 0.0625%.

Packaging:

For 10 ml, 15 ml in a bottle of dark glass or 10 ml, 15 ml in a bottle of dark glass with a lid-dropper, placed in a pack of cardboard with instructions for use.

Storage conditions:

List B. In the dark place at a temperature of no higher than 10 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after expiry date.
Terms of leave from pharmacies:Without recipe
Registration number:LSR-007996/08
Date of registration:10.10.2008
The owner of the registration certificate:PATENT-FARM, CJSC PATENT-FARM, CJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp27.11.2015
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