Аквадетрим®

General characteristics. Structure:

Active ingredient: 15 000 TL kolekaltsiferolf _{(D3 vitamin)}.

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

Pharmacological properties:

Pharmacodynamics. D3 vitamin is an active antirachitic factor. The most important function of D3 vitamin is regulation of metabolism of calcium and phosphates that promotes the correct 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. In comparison with D2 vitamin it is characterized for 25% by higher activity. Kolekaltsiferol 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 removal of calcium and phosphates kidneys. Concentration of calcium ions in blood causes maintenance of a tone of muscles of skeletal muscles, function of a myocardium, promotes carrying out nervous excitement, regulates blood coagulation process. Vitamin D is necessary for normal function of parathyroids, also participates in functioning of immune system, influencing production of lymphokines.

The lack of vitamin D of food, disturbance of its absorption, deficit of calcium, and also insufficient stay on a sunlight, during intensive growth of the child, leads to rickets, at adults to osteomalacy, pregnant women can have tetany symptoms, disturbance of processes of calcification of a bone tissue of newborns. The increased need for vitamin D arises at women in the period of a menopause as at them osteoporosis, in connection with hormonal disturbances often develops.

Pharmacokinetics. Aqueous solution of D3 vitamin is soaked up better, than Solutio oleosa. Premature children have an insufficient formation and intake of bile in intestines that breaks absorption of vitamins B a type of Solutio oleosa.

After oral administration колекальциферол it is absorbed in a small bowel. It is metabolized in a liver and kidneys. The elimination half-life of a kolekaltsiferol makes several days of blood and can last in case of a renal failure. Drug gets through a placental barrier and into mother's milk.

It is removed by kidneys in insignificant quantity, the most part is removed with bile. D3 vitamin has property of cumulation.

Indications to use:

- Prevention and treatment of deficit of vitamin D.

- Prevention and treatment of rickets, rakhitopodobny diseases, a gipokaltsiyemichesky tetany, osteomalacy and diseases of bones on a metabolic basis (such, as, a hypoparathyrosis and a pseudohypoparathyroidism).

- At complex treatment of osteoporosis, including post-menopausal.

Route of administration and doses:

Orally. To accept drug in a liquid spoon. 1 drop contains about 500 ME of D3 vitamin. If the doctor did not appoint differently, drug is used in the following dosages.

Preventive doses:

- the full-term newborns since 4 weeks of life, to 2-3 years at the correct leaving and sufficient stay in the fresh air: 500 - 1000 ME (1 - 2 drops) in days;
- premature children, since 4 weeks of life, the twins, babies who are in bad vital conditions: 1000 - 1500 ME (2 - 3 drops) in days. In summertime of year it is possible to limit a dose to 500 ME (1 drop) in days.
- pregnant women: a daily dose 500 ME (1 drop) D3 vitamin for the period of the entire period of pregnancy, or reception 1000 ME (2 drops) in days, since 28th week of pregnancy.
- in the post-menopausal period of 500 - 1000 ME (1 - 2 drops) in days.

Therapeutic doses:

- at rickets: daily 2000 - 5000 ME (4 - 10 drops), 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) blood and urine. It is necessary to begin with 2000 ME within 3 - 5 days. Then, at good tolerance, the dose is raised to an individual medical dose (most often 3000 ME). 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 in days.
- at treatment of rakhitopodobny diseases: 20 000 – 30 000 ME a day (40 – 60 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. Treatment is carried out under control of the doctor.
- at complex treatment of post-menopausal osteoporosis: 500 – 1000 ME (1-2 drops) in days.

The dosage is, as a rule, appointed taking into account amount of the vitamin D arriving with food.

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 a 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.

Not to apply along with D3 vitamin of high doses of calcium. During treatment periodic control of concentration of calcium and phosphates in blood and urine is necessary.

Pregnancy and period of a lactation. During pregnancy it is not necessary to apply D3 vitamin in high doses because of a possibility of manifestation of teratogenic action in case of overdose.

With care it is necessary to appoint D3 vitamin at the women nursing the child — the drug accepted in high doses by mother can cause overdose symptoms in the child.

During pregnancy and breastfeeding the dose of D3 vitamin should not exceed 600 ME in days.

Side effects:

Hypersensitivity to drug components, a hypervitaminosis of D (hypervitaminosis symptoms: appetite loss, nausea, vomiting; head, muscular and joint pains; locks; dryness in an oral cavity; polyuria; weakness; disturbance of mentality, including depression; loss of body weight; sleep disorder; temperature increase; in urine protein, leukocytes, hyaline cylinders appears; increase in level of calcium in blood and its allocation with urine; calcification of the kidneys, blood vessels easy is possible).

At emergence of signs of a hypervitaminosis of D it is necessary to cancel drug, to limit intake of calcium, to appoint vitamins A, With and Century.

Interaction with other medicines:

Antiepileptic means, rifampicin, Colestyraminum 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).

Contraindications:

Hypersensitivity to drug components, especially to benzyl alcohol. A hypervitaminosis of D, the increased concentration of calcium in blood (hypercalcemia), the increased release of calcium with urine (hypercalcuria), an urolithiasis (formation of calcic oxalic stones), a sarcoidosis, acute and chronic diseases of a liver and kidneys, a renal failure, an active form of a pulmonary tuberculosis. Children's age up to 4 weeks of life.

With care: a condition of an immobilization, at reception of tiazid, cardiac glycosides (especially foxglove glycosides); during pregnancy and breastfeeding.

At babies at predisposition to early overgrowing of fontanels (when from the birth the small sizes of the front top of the head are established).

Overdose:

Symptoms: loss of appetite, nausea, vomiting, locks, concern, thirst, polyuria, diarrhea, intestinal colic. Frequent symptoms are the headache, 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 process of calcification of soft tissues, including blood vessels, hearts, lungs and skin. Seldom cholestatic jaundice develops.

Treatment: To interrupt drug use. To see a doctor. To accept a large amount of liquid. If necessary hospitalization can be required.

Storage conditions:

In the place protected from light at a temperature not above 25 °C. To store in the places unavailable to children. Not to use after a period of validity. A period of validity - 3 years.

Issue conditions:

Without recipe

Packaging:

Drops for intake of 15 000 ME/ml. On 10 ml in bottles of dark glass with a polyethylene stopper dropper and the screwing-up polyethylene cover with a guarantee ring of "the first opening". 1 bottle together with the application instruction is placed in a cardboard pack.