Akvadetrim D3 vitamin

General characteristics. Structure:

Active agent - cholecalciferol of 15 000 ME.

Excipients: a macrogoal глицерилрицинолеат, sucrose (250 mg), hydrophosphate sodium dodecahydrate, citric acid monohydrate, fragrance anisic, benzyl alcohol (15 mg), the water purified.

Pharmacological properties:

Pharmacokinetics. Aqueous solution of D3 vitamin is better soaked up, than Solutio oleosa (that matters at use for premature children). After oral administration cholecalciferol absorption happens in a small intestine by means of passive diffusion from 50 to 80% of a dose.

Absorption - bystry (in distal department of a small intestine), comes to lymphatic system, gets into a liver and in the general blood stream. In blood contacts alfa2-globulins and partially albumine. Collects in a liver, bones, skeletal muscles, kidneys, adrenal glands, a myocardium, fatty tissue. TCmax (the period of the maximum concentration) in fabrics - 4-5 h, then concentration of drug decreases a little, remaining, a long time at the constant level. In the form of polar metabolites it is localized preferential in membranes of cells and microsomes, mitochondrions and kernels. Gets through a placental barrier, it is allocated with breast milk.

It is deposited in a liver.

It is metabolized in a liver and kidneys: in a liver turns into an inactive metabolite кальцифедиол (25 dihydrocholecalciferol), in kidneys - from a kaltsifediol calcitriol (1,25 dihydroxycholecalciferol) and an inactive metabolite 24,25 dihydroxycholecalciferol turns into an active metabolite. Is exposed to enterohepatic recirculation.

Vitamin D and its metabolites are removed with bile, insignificant quantity - kidneys. Kumuliruyet.

Pharmacodynamics. Akvadetrim D3 vitamin is an antirachitic perparat. Akvadetrim D3 vitamin is the most important function regulation of metabolism of calcium and phosphate that promotes a mineralization and growth of a skeleton. D3 vitamin is a natural form of vitamin D which is formed at the person in skin under the influence of sunshine. Plays an essential role in absorption of calcium and phosphates from intestines, in transport of mineral salts and in the course of calcification of bones, regulates also a reabsortion of calcium and phosphates kidneys. Calcium ions participate in a row the important biochemical processes causing maintenance of a tone of muscles of skeletal muscles in carrying out nervous excitement, in the course of a blood coagulation. Akvadetrim D3 vitamin stimulates products of lymphokines.

Indications to use:

Prevention and treatment:

- hypo - and vitamin D avitaminosis (conditions of the increased need of an organism for vitamin D at a nephrogenic osteopathy, defective and unbalanced food, a syndrome of a malyabsortion, insufficient insolation, a hypocalcemia, a hypophosphatemia, a renal failure, cirrhosis, pregnancy and the period of a lactation);

- rickets;

- gipokaltsiyemichesky tetany;

- osteomalacy and diseases of bones with metabolism disturbance (a hypoparathyrosis and a pseudohypoparathyroidism).

As a part of complex therapy:

- osteoporosis at women in the postmenopauzny period;

- rakhitopodobny diseases.

Route of administration and doses:

Drug is accepted orally with a small amount of liquid.

1 drop contains about 500 ME of D3 vitamin.

Preventive doses:

- the full-term newborn from 4 weeks of life to 2-3 years of life at the correct leaving and sufficient stay in the fresh air - 500 ME (1 drop) in days;

- the premature newborn about 4 weeks of life, and also to the twins, babies who are in bad vital conditions - 1000 ME (2 drops) in days within one year. In summertime of year it is possible to limit a dose to 500 ME (1 drop) in days. Duration of therapy makes up to 2-3 years of life;

- to pregnant women - a daily dose 500 ME D3 vitamins for the period of the entire period of pregnancy, or 1000 ME/days since the 28th week of pregnancy;

- to women in the postmenopauzny period - 500 – 1000 ME (1-2 drops) a day, within 2-3 years, about need of repeated courses of therapy are solved by the doctor.

Therapeutic doses:

- at rickets begin with 2000 ME within 3 - 5 days, then at good tolerance raise a dose to an individual medical dose of 2000 - 5000 ME (4-10 drops) daily, most often 3000 ME, depending on severity of rickets (I, II, or III) and course option, for 4-6 weeks, under careful control of a clinical state and a research of biochemical indicators (calcium, phosphorus, an alkaline phosphatase) of blood and urine. The dose 5000 ME is appointed only at the expressed bone changes.

As required after one week of a break, it is possible to repeat a course of treatment. Treatment is carried out before obtaining accurate medical effect, with the subsequent transition to a preventive dose of 500 - 1500 ME/days. The period of duration of a course of treatment and prevention is determined by the doctor.

At rakhitopodobny diseases of 10 000 - 20 000 ME in days (20 – 40 drops) depending on age, weight and disease severity, under control of biochemical indicators of blood and the analysis of urine. Course of treatment of 4-6 weeks. About need of repeated courses of therapy the doctor solves.

At osteomalacy and postmenopauzny osteoporosis as a part of complex therapy of 500 - 1000 ME (1-2 drops) in days.

The dosage is, as a rule, appointed taking into account amount of the vitamin D arriving as a part of other foodstuff.

Features of use:

To avoid overdose. Individual ensuring a certain requirement has to consider all possible sources of this vitamin.

Too high doses of D3 vitamin applied for a long time or shock doses, can be the cause of a chronic hypervitaminosis of D3.

Definition of daily need of the child for vitamin D and way of its use have to be established by the doctor individually and every time to be exposed to correction during periodic inspections, especially in the first months of life.

It is careful to apply at the immobilized patients. Not to use along with D3 vitamin calcium drugs in high doses.

Treatment is carried out under periodic control of level of calcium and phosphorus in blood and urine. 

Care at purpose of drug is necessary for elderly people as at this category of persons adjournment of calcium in lungs, kidneys and blood vessels amplifies. 

With care to apply at persons ill with a diabetes mellitus.

During pregnancy it is not necessary to apply D3 Vitamin in high doses of 2 000 ME because of a possibility of manifestation of teratogenic action in case of overdose. With care it is necessary to appoint D3 Vitamin in the period of a lactation as the drug accepted in high doses by mother can cause overdose symptoms in the child.

 Does not influence ability to manage the vehicle or potentially dangerous mechanisms.

Side effects:

It is not noted at use in the recommended doses.

In case of seldom noted individual hypersensitivity to D3 vitamin or uses of too high doses during the long period D3 hypervitaminosis can result:

- disturbances of mentality, including depression;

- appetite loss, nausea, vomiting, dryness in a mouth, locks;

- head, muscular and joint pains;

- loss of body weight;

- polyuria;

- increase in level of calcium in blood and urine;

- formation of stones in kidneys and calcification of soft tissues.

Interaction with other medicines:

Antiepileptic means, rifampicin, холестирамин, reduce a D3 vitamin reabsorption.

Use along with thiazide diuretics increases risk of manifestation of a hypercalcemia.

Simultaneous use with cardiac glycosides can strengthen their toxic action (the risk of manifestation of disturbances of a heart rhythm increases).

Toxic action is weakened by vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamin, Riboflavinum.

Under the influence of barbiturates (including phenobarbital), Phenytoinum and Primidonum the need for the kolekaltsiferol can increase considerably (increase metabolism speed).

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

The calcitonin, derivatives of etidronovy and pamidronovy acids, пликамицин, gallium nitrate and glucocorticosteroids reduce effect.

Colestyraminum, колестипол and mineral oils reduce absorption in a digestive tract of fat-soluble vitamins and demand increase in their dosage.

Increases absorption of phosphorus drugs and risk of emergence of a hyperphosphatemia. At simultaneous use from sodium fluoride the interval between reception has to make not less than 2 h; with peroral forms of tetracyclines - not less than 3 h.

Simultaneous use with other analogs of vitamin D increases risk of development of a hypervitaminosis.

Contraindications:

- hypersensitivity to drug components, especially to benzyl alcohol;

- hypervitaminosis D;

- liver and renal failure;

- the increased level of calcium and phosphorus in blood and urine;

- calcic nephroliths;

- sarcoidosis;

- the neonatality period up to 4 weeks.

Overdose:

Symptoms: concern, thirst, loss of appetite, nausea, vomiting, diarrhea, locks, intestinal colic, polyuria. Frequent symptoms are head, muscular and joint pains, disturbances of mentality, including a depression, a stupor, an ataxy and the progressing loss of body weight. The renal failure with the albinuriya, an erythrocyturia and a polyuria raised by potassium loss, a hyposthenuria, a nocturia and increase in arterial pressure develops. In hard cases there can be opacification of a cornea, less often hypostasis of a nipple of an optic nerve, an inflammation of an iris of the eye up to development of a cataract. Stones in kidneys can be formed, there is a calcification of soft tissues, including blood vessels, hearts, lungs and skin. Seldom cholestatic jaundice develops.

Treatment: drug withdrawal, plentiful drink of liquids, symptomatic therapy.

Storage conditions:

To store in the place protected from light at a temperature from 5 °C to 25 °C.

To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

On 10 ml in a bottle from dark glass with a polyethylene stopper dropper and the screwing-up polyethylene cover with a guarantee ring of "the first opening" together with the instruction on a medical use in a cardboard pack.