Akvadetrim D3 Vitamin

General characteristics. Structure:

Active agent: cholecalciferol of 15000 ME/ml.

Pharmacological properties:

Pharmacodynamics. D3 vitamin — an active antirachitic factor. The most important function of vitamin D is regulation of metabolism of calcium and the phosphates promoting the correct mineralization and growth of a skeleton.
D3 vitamin is a natural form of vitamin D which is formed at animals and people. In comparison with D2 vitamin its activity is 25% higher.
Vitamin D is necessary for functioning of epithelial body, intestines, kidneys and bone system. Plays an important role in absorption of calcium and phosphates in intestines, transport of mineral salts and process of calcification of bones, regulates release of calcium and phosphates kidneys. Concentration of calcium ions matters for a normal current of a number of important biochemical processes; they play an important role in maintenance of a tone of skeletal muscles, participate in carrying out nervous excitement, take part in blood coagulation process. D3 vitamin is necessary for normal functioning of the immune system influencing production of lymphokines.
Deficit of D3 vitamin in food, decrease in its absorption, deficit of calcium, and also lack of sufficient insolation during intensive growth of the child lead to development of rickets in children of early age and disturbance of formation of an adamantine substance of tooth, in adults — to osteomalacy, during pregnancy and feeding by a breast — to emergence of symptoms of a tetany.
Women in the period of a menopause with symptoms of osteoporosis in connection with hormonal disturbances have to receive a sufficient dose of D3 vitamin.

Pharmacokinetics. Absorption. Water solution of D3 vitamin is better soaked up, than oil. At premature children note insufficient formation and intake of bile in intestines that breaks absorption of vitamins B a type of oil solutions.
After oral administration колекальциферол it is absorbed in a small intestine.
Distribution. Gets through a placental barrier and it is excreted in breast milk.
Metabolism. It is metabolized in a liver and kidneys, being transformed to an active metabolite — calcitriol which, connecting to carrier protein, is transported in target organs (intestines, bones, kidneys). T½ makes of a blood plasma up to several days and can be more long in case of a renal failure. It is removed with urine and a stake.
In 6 h after administration of drug D3 vitamin already takes part in regulation of exchange of phosphorus and calcium in an organism. After reception of D3 vitamin in 48 h note substantial increase of level of a kolekaltsiferol in a blood plasma.

Indications to use:

• prevention of rickets at children;
• prevention of deficit of vitamin D at the patients belonging to groups of high risk at malabsorption (chronic diseases of a small intestine, biliary cirrhosis, a state after a resection of a stomach and/or intestines);
• treatment of rickets and osteomalacy;
• the supporting treatment of osteoporosis.

Route of administration and doses:

Apply orally. One drop contains 500 ME D3 vitamins. Precisely to measure a drug dose, it is necessary to hold at the same time a bottle at an angle 45 °.
Usual dose for the purpose of prevention of rickets at the full-term children aged from 4 weeks till 1 year at the correct leaving and sufficient stay under the influence of sunshine — 1 drop a day (500 ME vitamins D a day), at premature — 1000 ME vitamins D a day. It is possible to limit a dose to 500 ME in the solar summer (1 drop a day). For the 2-3rd year of life there can be a need for further purpose of vitamin D, especially during the winter period.
Children of chest age of a drop are given with a spoon of milk or porridge. It is not recommended to add a drop to a small bottle or to a plate as at the same time it is impossible to guarantee reception of all dose. Children of advanced age and adults accept Akvadetrim D3 Vitamin with a liquid spoon.
Duration of reception is defined by the doctor.
At treatment of rickets and osteomalacy the dose makes 2–10 drops a day (1000-5000 ME vitamins D a day). Treatment duration — 1 year.
At a maintenance therapy of osteoporosis the dose makes 2–6 drops a day (1000-3000 ME vitamins D a day).
Prevention of deficit of vitamin D at the patients belonging to groups of high risk — 1–2 drops a day (500-1000 ME vitamins D a day).
Malabsorption prevention — 6–10 drops a day (3000-5000 ME vitamins D a day).
At use of doses over 1000 ME of vitamin D a day, and also at continuous administration of drug it is necessary to control calcium level in a blood plasma.

Features of use:

Individual ensuring a certain requirement has to consider all possible sources of this vitamin.
Rather high doses Akvadetrim D3 Vitamin that are applied it is long, 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 need to be established individually and every time to subject verifications during the periodic researches, especially in the first months of life.
With care apply at the immobilized patients who accept thiazide diuretics, foxglove glycosides, and also at patients with a nephrolithiasis, heart diseases.
High doses of calcium do not apply along with Akvadetry D3 Vitamin.
During administration of drug it is recommended to control the level of calcium, phosphates and glucose in a blood plasma and urine.
Use during pregnancy and feeding by a breast. The chronic overdose (a hypercalcemia, transplacental penetration of metabolites of D3 vitamin into a fruit) arising at long reception of D3 vitamin in doses which exceed recommended can cause defects of physical fetation, and also an aorta stenosis.
Vitamin D gets into breast milk therefore during feeding by a breast drug needs to be used only on doctor's orders.
Children. Apply at children from 4 weeks age.
Ability to influence speed of response at control of vehicles or work with other mechanisms. There are no messages. However at control of vehicles or work with other mechanisms it is recommended to observe extra care, considering a possibility of development of undesirable reactions from a nervous system.

Side effects:

As a rule, do not arise at use of drug in the recommended doses.
In case of individual hypersensitivity to D3 vitamin that is noted seldom, can be shown a hypervitaminosis of D.
From a GIT: appetite loss, nausea, vomiting, a lock, dryness in a mouth.
From TsNS: headache, disturbance of mentality, depression.
From an urinary system: increase in level of calcium in blood and/or in urine, an urolithiasis and calcification of fabrics, a polyuria.
From skin: allergic reactions, including urticaria, skin rash, itch.
From a musculoskeletal system: muscle and joints pain.
Other effects: body degrowth.

Interaction with other medicines:

Antiepileptic means, rifampicin, Neomycinum, Colestyraminum, liquid paraffin reduce a drug resorption Akvadetrim D3 Vitamin.
At simultaneous use with thiazide diuretics the risk of development of a hypercalcemia increases.
The combined use with cardiac glycosides increases their toxic action (the risk of development of disturbances of a heart rhythm grows).
Ketokonazol can reduce biosynthesis and a catabolism 1,25(OH) 2-kolekaltsiferol.
Co-administration of D3 vitamin with metabolites or analogs of vitamin D perhaps only as an exception and only at control of level of calcium in a blood plasma.

Contraindications:

Hypersensitivity to drug components, a hypervitaminosis of D, a hypercalcemia, a hypercalcuria, an urolithiasis, a sarcoidosis, a renal failure, a nephrolithiasis. Do not apply at children aged to 4 weeks in view of possible emergence of hypersensitivity to benzyl alcohol.

Overdose:

Toxic symptoms as a result of acute poisoning are shown seldom, more often — at newborns and children is after overdose, after use of 100 000 ME or there are more vitamin D in days.
Overdose signs: weakness, lack of appetite, nausea, vomiting, lock, concern, thirst, polyuria, hyperacidity of a stomach, diarrhea, intestinal colic. Sweating, dizziness, arrhythmia are possible.
Frequent symptoms: muscle and joints pain, a headache, a depression, disturbance of mentality, an ataxy, a stupor and the progressing body degrowth. The renal failure with the albuminuria, an erythrocyturia and a polyuria raised by potassium loss, a hyposthenuria, a nocturia and increase in the ABP develops.
Opacification of a cornea can appear in hard cases, is more rare — hypostasis of a nipple of an optic nerve, an inflammation of an iris of the eye up to development of a cataract.
Concrements in kidneys, liming in kidneys, soft tissues, such as blood vessels, heart, lungs and skin can be formed.
Seldom cholestatic jaundice develops.
Treatment: drug withdrawal, a bed rest, a diet with low contents of calcium, the use of a large amount of liquid, use of purgatives, at a considerable hypercalcemia — in/in introduction of a large amount of isotonic solution of sodium of chloride, administration of furosemide or derivatives of Acidum etacrynicum, glucocorticosteroids, calcitonin drugs, carrying out a hemodialysis.
There is no specific antidote.

Storage conditions:

In the place protected from light at a temperature of 5-25 °C.

Issue conditions:

Without recipe

Packaging:

Solution for перорал. comment водн. 15000 ME/ml фл. with a dropper of 10 ml.