AKVADETRIM
Active material: Kolekaltsiferol
When ATH: A11CC05
CCF: Preparation, regulates the exchange of calcium and phosphorus
ICD-10 codes (testimony): E55, E55.0, E58, M81.0, M81.1, M81.2, M81.4, M81.8, M82, M83, M90, R29.0
Manufacturer: MEDANA PHARMA S.A. (Poland)
Pharmaceutical form, composition and packaging
◊ Drops for intake Colorless, clear or slightly opalescent, with the aniseed smell.
| 1 ml (30 drop.) | |
| Kolekaltsiferol (wreathed. D3) | 15 thousand IU |
Excipients: makrogola glicerilricinoleat, sucrose, sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, anise flavoring, benzyl alcohol, Purified water.
10 ml – dark glass bottles with cork-dropper (1) – packs cardboard.
Pharmacological action
Preparation, regulates the exchange of calcium and phosphorus. Vitamin D3 is an active antirahiticheskim factor. The most important function of vitamin D is the regulation of calcium and phosphate metabolism, that contributes to the mineralization and growth of the skeleton.
Vitamin D3 is a natural form of vitamin D, which is formed in the skin of a person under the influence of sunlight. Compared with vitamin D2 It is characterized by the 25% higher activity.
Kolecalziferol plays a significant role in the absorption of calcium and phosphate in the gut, transport of mineral salts and during the calcification of bones, also regulates the excretion of calcium and phosphate in the kidneys.
The presence in the blood of calcium ions in physiological concentrations maintains muscle tone skeletal muscles, myocardial function, promotes nerve stimulation, regulates the process of blood clotting.
Vitamin D is necessary for normal functioning of the parathyroid glands, also involved in the functioning of the immune system, affecting the production of lymphokines.
Vitamin D deficiency in food, violation of its suction, calcium deficiency, as well as lack of exposure to the Sun during rapid growth the child leads to about rickets, adult – to osteomalacia, pregnant women may experience symptoms of tetany, violation processes calcifications bones of newborns.
Increased need for vitamin D occurs in women during menopause, because they often develops osteoporosis due to hormonal disorders.
Pharmacokinetics
Absorption
Aqueous solution kolecalziferola absorbed better, than oily solution (It has value when applied preterm infants, tk. This category of patients, there is insufficient production and bile in the intestine, that violates the absorption of vitamins in the form of oil solutions).
After intake of kolecalziferol absorbed from the small intestine.
Distribution and metabolism
Metabolised in the liver and kidneys.
It penetrates through the placental barrier. Provided with breast milk. Kolecalziferol koumouliruet in the body.
Deduction
T1/2 is a few days. Report the news in small quantities, most of the displays with bile.
Pharmacokinetics in special clinical situations
When kidney failure can increase T1/2.
Testimony
Prevention and Treatment:
-Vitamin D deficiency;
-a rickets and rahitopodobnykh diseases;
— gipokalciemicheskoj tetany;
-osteomalacia;
-metabolic osteopatij (hypoparathyreosis and pseudohypoparathyreosis).
Osteoporosis treatment, incl. postmenopauznogo (in the complex therapy).
Dosage regimen
Dose set individually, given the amount of vitamin D, who receives patient dietary composition and in the form of medicines.
Drug taking in 1 Spoon liquid (1 drop contains 500 IU kolecalziferola).
With the aim of prevention term infants with 4 weeks of life to 2-3 years, with proper care and adequate staying outdoors, the drug is prescribed in a dose 500-1000 ME (1-2 drops)/d.
Premature children with 4 weeks of life, twins and children, living in adverse conditions, appointed 1000-1500 ME (2-3 drops)/d.
During summer months, the dose can be reduced to 500 ME (1 drop)/d.
Pregnant daily prescribed 500 ME (1 drop)/day throughout pregnancy, or 1000 IU / day, beginning with 28 week of pregnancy.
IN postmenopauzne period appointed 500-1000 ME (1-2 drops)/d.
With the aim of treatment rickets the drug is prescribed daily dose 2000-5000 ME (4-10 drops)/day for 4-6 weeks depending on the severity of rickets (I, (II) or (III)) and variants of the disease. You should monitor the patient's clinical status and biochemical parameters (calcium level, Phosphorus, ALP activity in the blood and in the urine). The initial dose is 2000 IU/day for 3-5 days, then, with good endurance dose increase to individual medical (typically up to 3000 IU / day). Dose 5000 IU/day is assigned only when expressed bone changes. If necessary, after 1 the week break the course of treatment can be repeated.
Treatment should continue until a clear therapeutic effect, with the subsequent transition to preventive dose 500-1500 IU / day.
At the treatment of rahitopodobnykh diseases appointed 20 000-30 000 ME (40-60 drops)/day depending on age, body mass index and severity of diseases, under the supervision of the biochemical parameters of blood and urine analysis. A course of treatment – 4-6 weeks.
At treatment of osteoporosis postmenopauznogo (in the complex therapy) appointed 500-1000 ME (1-2 drops)/d.
Side effect
Symptoms of hypervitaminosis D: loss of appetite, nausea, vomiting; head, muscle and joint pain; constipation; dry mouth; polyuria; weakness; madness, incl. depression; weight loss; sleep disturbance; temperature rise; appears in the urine protein, leukocytes, hyaline cylinders; increase the level of calcium in the blood and its allocation of urine; possible calcification kidney, blood vessels, light. When signs of gipervitaminoza (D) cancel product, limit the intake of calcium, assign the vitamins and, With and in.
Other: possible reactions of hypersensitivity.
Contraindications
- hypervitaminosis D;
- Hypercalcemia;
- Hypercalciuria;
- Urolithiasis disease (the formation of calcium oxalate kidney stones);
- Sarkoidoz;
-acute and chronic kidney disease;
- Renal failure;
-active form of pulmonary tuberculosis;
- Children up to age 4 weeks;
- Hypersensitivity to vitamin D3 and other ingredients (especially to benzilovomu alcohol).
FROM caution You should use the drug immobilized patients; When taking tiazidov, cardiac glycosides; Pregnancy and lactation (breast-feeding); infants with predisposition to early occlusion of fontanelles (When installed from birth the small sizes of the anterior temechka).
Pregnancy and lactation
During pregnancy should not be used Akvadetrim® in high doses, due to the possibility of teratogenicity in the case of an overdose.
The caution should appoint Akvadetrim® lactation, tk. in applying the drug in high doses from a nursing mother may develop symptoms of overdose in a child.
During pregnancy and breastfeeding dose of vitamin D3 should not exceed 600 ME/day.
Cautions
In appointing the drug should take into account all possible sources of vitamin D.
Use of the drug for medicinal purposes in children should be under careful medical supervision and adjust the dosage during periodic surveys, especially in the first months of life.
Prolonged use of Akvadetrima® at high doses or use of the drug in shock doses can lead to chronic gipervitaminozu (D)3.
Should not simultaneously apply Akvadetrim® and calcium in high doses.
Monitoring of laboratory parameters
In applying the drug for medicinal purposes there is a need to control the level of calcium in the blood and urine.
Overdose
Symptoms: decreased appetite, nausea, vomiting, constipation, anxiety, thirst, polyuria, diarrhea, kišečnaâ how. Common symptoms are headache, muscular and articular pain, depression, mental disorders, ataxia, stupor, progressive loss of body weight. Develops the kidneys with albuminuria, jeritrocituriej and polyuria, increased potassium loss, gipostenuriej, nikturiej and increase in ad.
In severe cases, may, the clouding of cornea, less often – swelling of the optic nerve papilla, inflammation of the IRIS until the development of cataract. The formation of kidney stones, calcification of soft tissues, incl. blood vessels, hearts, light, skin.
Rarely develops cholestatic jaundice.
Treatment: removal of the drug. Appoint drinking large amounts of fluids. If necessary, may require hospitalization.
Drug Interactions
If you are applying to Akvadetrima® with antiepileptic drugs, rifampicin, kolestiraminom removals kolecalziferola is reduced.
If you are applying to Akvadetrima® and a thiazide diuretic increases the risk of hypercalcemia.
Simultaneous application Akvadetrima® with cardiac glycosides may intensify their toxic effect (increased risk of arrhythmias).
Conditions of supply of pharmacies
The drug is resolved to application as an agent Valium holidays.
Conditions and terms
The drug should be stored out of reach of children, dark place at a temperature no higher than 25 ° C. Shelf life – 3 year.
