DIVOS-D3 [Cholecalciferol] 15,000 IU Oral Drops

TRADENAME

DIVOS-D3, DIVOS-D3

INTERNATIONAL NON-PROPRIETARY NAME

Cholecalciferol, Cholecalciferol

PHARMACEUTICAL FORM

Drops for oral administration.

Description: transparent homogeneous solution of colorless or slightly yellowish color.

COMPOUND

1 ml of the drug contains

Active substance: cholecalciferol (vitamin D3) 15000 IU. Excipients: sucrose, benzyl alcohol, citric acid monohydrate, disodium phosphate anhydrous, macragol glyceryl ricinoleate, strawberry flavor, red food coloring, potassium sorbate, purified water.

ATC CODE A11CC05 PHARMACOTHERAPEUTIC GROUP

A drug that regulates the exchange of calcium and phosphorus. PHARMACOLOGICAL PROPERTIES

Vitamin D3 is an active anti-rachitic factor. The most important function of vitamin D 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 formed in the human skin upon exposure to sunlight. Compared to vitamin D2, it is characterized by a 25% higher activity. 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 presence of calcium ions in the blood in physiological concentrations ensures 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 functioning of the parathyroid glands, and is also involved in the functioning of the immune system, influencing the production of lymphokines.

Vitamin D deficiency in food, malabsorption, calcium deficiency, and also inadequate residence on the sun in period quick growth a child leads to rickets, in adults - to osteomalacia, in pregnant women relieve symptoms of tetany, violation of bone calcification processes 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 cholecalciferol is absorbed better than an oil solution. This is important when used in premature babies, since in this category of patients there is a lack of production and flow of bile into the intestine, which disrupts the absorption of vitamins in the form of oil solutions.

After oral administration, cholecalciferol is absorbed in the small intestine. The drug crosses the placental barrier. It is allocated with breast milk. Cholecalciferol accumulates in the body.

Cholecalciferol is metabolized in the liver and kidneys, transforming into an active metabolite - calcitriol, which, when combined with a carrier protein, is transported to target organs (intestines, bones, kidneys).

The plasma half-life is up to several days and may be longer in case of impaired renal function. Displayed kidneys in insignificant quantity. Big part cholecalciferol and its metabolic products are excreted in the bile into the intestine, from which they can be reabsorbed, creating an enterohepatic circulation system, or excreted in the faeces.

INDICATIONS FOR USE

Prevention and treatment:

-   vitamin D deficiency, including in high-risk groups (malabsorption, chronic diseases of the small intestine, biliary cirrhosis of the liver, condition after resection of the stomach and / or intestines);

- rickets and rickets diseases;

- hypocalcemic tetany;

- osteomalacia;

- metabolic osteopathies (hypoparathyroidism and pseudohypoparathyroidism). Treatment of osteoporosis, including postmenopausal (as part of a comprehensive therapy).

METHOD OF APPLICATION AND DOSES

DIVOS-D3 is taken orally, dissolved in one spoonful of liquid (1 drop contains 500 IU of cholecalciferol). Infants are given drops with a spoonful of milk or cereal. Adding drops to a bottle or dish is not recommended as it cannot be guaranteed that the entire dose will be taken. The dose is set individually, taking into account the amount of vitamin D that the patient receives as part of the diet and in the form of drugs.

Prophylactic doses

full-term newborns from 3-4 weeks life before 2-3 years at proper care and sufficient exposure to fresh air, the drug is prescribed in dose of 500-1000 IU (1-2 drops) per day.

premature children With 7-10 daytime age, twins and children living in adverse conditions, appoint 1000-1500 IU (2-3 drops) per day.

In the summer, the dose can be reduced to 500 IU (1 drop) per day. Pregnant women are prescribed 500 IU (1 drop) daily throughout the pregnancy or 1000 IU (2 drops) in day, beginning With 28 weeks pregnancy. In the postmenopausal period, the drug is prescribed 500-1000 IU (1-2 drops) per day.

Therapeutic doses

At rickets a drug appoint daily in dose 2000-5000 IU (4-10 drops) per day for 4-6 weeks, depending on the severity of rickets (I, II or

III) and the course of the disease. At the same time, it is necessary to control clinical condition patient and biochemical indicators (calcium level, phosphorus, activity alkaline phosphatase in blood and in urine). The initial dose is 2000 IU (4 drops) per day for 3-5 days, then at good portability dose increase before individual medical (usually up to 3000 IU (6 drops) per day). A dose of 5000 IU (10 drops) per day is prescribed only for severe bone changes. If necessary after one week break well treatment can repeat. Treatment should continue until a clear therapeutic effect is obtained, with the subsequent transition   for a prophylactic dose of 500-1500 IU (1-3 drops) per day.

In the treatment of rickets-like diseases, 20,000-30,000 IU (40-60 drops) are prescribed. in day in dependencies from age, masses body and gravity diseases, under the control of biochemical parameters of blood and urinalysis. Course of treatment: 4-6 weeks.

In the treatment of postmenopausal osteoporosis (as part of complex therapy), 500-1000 IU (1-2 drops) per day are prescribed.

CONTRAINDICATIONS

-   hypersensitivity to vitamin D3 and other components of the drug (especially to benzyl alcohol);

- hypervitaminosis D;

- increased levels of calcium in the blood and urine;

- urolithiasis (formation of calcium oxalate stones in the kidneys);

- sarcoidosis;

- kidney failure. FROM caution should apply a drug at patients in able immobilization; at admission thiazides, cardiac glycosides; at pregnancy and in lactation period; in infants with a predisposition to early overgrowth of fontanelles (when small sizes of the anterior crown are established from birth).

- SIDE EFFECT

When using the drug in recommended doses, side effects are not observed.

In the case of rarely noted individual hypersensitivity to vitamin D3 or as a result of the use of too high doses for an extended period of time, symptoms may appear hypervitaminosis D.

Symptoms of hypervitaminosis D: loss of appetite, nausea, vomiting; headache, muscle and joint pain; constipation; dry mouth; polyuria; weakness; mental disorders, including depression; weight loss; sleep disturbance; temperature rise; protein, leukocytes, hyaline cylinders appear in the urine; an increase in the level of calcium in the blood and its excretion in the urine; possible calcification of the kidneys, blood vessels, lungs. If signs of hypervitaminosis D appear, it is necessary to cancel the drug, limit the intake of calcium, prescribe vitamins A, C and B.

SPECIAL INSTRUCTIONS

When prescribing the drug, it is necessary to take into account all possible sources of vitamin D.

The use of the drug for medicinal purposes in children should be carried out under careful medical observation and adjust mode dosing during periodic examinations, especially in the first months of life.

Long-term use of DIVOS-D3 in high doses or the use of the drug in loading doses can lead to chronic hypervitaminosis D3. DIVOS-D3 and high doses of calcium should not be co-administered.

When using the drug for medicinal purposes, it is necessary to control the level of calcium in the blood and urine.

EFFECT ON THE ABILITY TO DRIVE VEHICLES AND MANAGE MECHANISMS

DIVOS-D3 does not affect the ability to drive vehicles or complex mechanisms.

USE IN PREGNANCY AND LACTATION

High doses of DIVOS-D3 should not be used during pregnancy due to the potential for teratogenicity in case of overdose.

With caution, DIVOS-D3 should be prescribed during lactation, since when using the drug in high doses in a nursing mother, symptoms of an overdose in a child may develop.

PEDIATRIC APPLICATION

The drug is used in children from 1 week of age.

INTERACTION WITH OTHER DRUGS

With the simultaneous use of DIVOS-D3 with antiepileptic drugs, rifampicin, cholestyramine, the absorption of cholecalciferol decreases. With the simultaneous use of DIVOS-D3 and thiazide diuretics, the risk of developing hypercalcemia increases.

Simultaneous use of DIVOS-D3 with cardiac glycosides may increase their toxic effect (increases the risk of developing cardiac arrhythmias ).

OVERDOSE

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 weight loss. Renal dysfunction develops with albuminuria, erythrocyturia and polyuria, increased loss of potassium, hypostenuria, nocturia and increased blood pressure.

In severe cases, clouding of the cornea is possible, less often - swelling of the papilla visual nerve, inflammation iridescent shells up to before development cataracts. Possible formation of kidney stones, calcification of soft tissues, including number of blood vessels, heart, lungs, skin.

Rarely develops cholestatic jaundice.

Treatment: drug withdrawal. Assign a large amount of liquid. Hospitalization may be required if necessary.

RELEASE FORM

Drops for oral administration of 15 ml in a yellow glass bottle with a dropper stopper and a screw-on protective cap equipped with a safety ring.

Bottle with leaflet in a cardboard box.

STORAGE CONDITIONS

Store in a place protected from light at a temperature not exceeding 25ºС. Keep out of the reach of children!

After opening the vial, use the drug within 6 months.

BEST BEFORE DATE

3 years from date of manufacture.

Do not use after the expiration date.

TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES

Released without a prescription.