Instructions for use Koledan drops oral solution 15000 IU/ml dropper bottle 10 ml No. 1
Composition
active ingredient: cholecalciferol;
1 ml of solution contains 15,000 IU of cholecalciferol;
excipients: polyoxyl 35 castor oil; sucrose; citric acid, monohydrate; benzyl alcohol; Tutti-Frutti flavoring; anhydrous sodium hydrogen phosphate; purified water.
Dosage form
Oral drops, solution.
Main physicochemical properties: transparent, homogeneous, colorless or slightly yellowish solution.
Pharmacotherapeutic group
Vitamins. Vitamin D preparations and its analogues. ATX code A11C C05.
Pharmacological properties
Pharmacodynamics
Vitamin D3 is an active anti-rachitic factor. The most important function of vitamin D is to regulate calcium and phosphate metabolism, which contributes to proper mineralization and skeletal growth.
Vitamin D3 is the natural form of vitamin D produced in humans by exposure to sunlight. It is 25% more active than vitamin D2.
It is necessary for the functioning of the parathyroid glands, intestines, kidneys and bone system. Cholecalciferol plays a significant role in the absorption of calcium and phosphates from the intestines, in the transport of mineral salts and in the process of bone calcification, regulates the excretion of calcium and phosphates by the kidneys. The presence of calcium ions in the blood in physiological concentrations ensures the maintenance of skeletal muscle tone, myocardial function, promotes the conduction of nervous excitation, regulates the process of blood clotting. Vitamin D is also involved in the functioning of the immune system, affecting the production of lymphokines.
Lack of vitamin D3 in food, impaired absorption, calcium deficiency, and insufficient exposure to the sun during a child's rapid growth period lead to rickets, and in adults - to osteomalacia, in pregnant women - to the appearance of symptoms of tetany and malformation of tooth enamel in infants.
Women in menopause, who often suffer from osteoporosis, need to increase their dose of vitamin D3 due to hormonal disorders.
Pharmacokinetics
Absorption.
An aqueous solution of vitamin D3 is better absorbed than an oily solution. Premature babies have insufficient bile production and flow to the intestines, which impairs the absorption of vitamins in the form of oily solutions.
After oral administration, cholecalciferol is absorbed in the small intestine.
Distribution.
Penetrates through the placental barrier and into breast milk.
Metabolism.
It is metabolized in the liver and kidneys, turning into an active metabolite - calcitriol, which combines with a carrier protein and is transported to target organs (intestine, bones, kidneys). The half-life in the blood is several days and may be prolonged in case of kidney disease.
Breeding.
Excreted in urine and feces.
Vitamin D3 is involved in the regulation of phosphorus and calcium metabolism in the body 6 hours after taking the drug.
After taking vitamin D3, a significant increase in the level of cholecalciferol in the blood serum is observed within 48 hours.
Indication
Prevention of rickets, including in premature infants. Prevention of vitamin D3 deficiency in patients with malabsorption and high-risk patients without malabsorption disorders. Supportive treatment of osteoporosis. Treatment of rickets and osteomalacia. Treatment of hypoparathyroidism.
Contraindication
Hypersensitivity to the active substance or to other components of the drug; hypercalcemia and/or hypercalciuria; hypervitaminosis D; sarcoidosis; renal failure; nephrolithiasis; tuberculosis; pseudohypoparathyroidism (the need for vitamin D may be lower than during the period of normal sensitivity to the vitamin). Rare hereditary fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase insufficiency.
Interaction with other medicinal products and other types of interactions
When cholecalciferol is used simultaneously with other drugs, the following interactions are possible:
with aluminum- and magnesium-containing antacids – increased toxic effects of aluminum on bones and the risk of developing hypermagnesemia in patients with renal failure;
with drugs containing high doses of calcium or phosphorus - increased risk of hyperphosphatemia;
with ketoconazole – reduction in biosynthesis and catabolism of the metabolite 1,25(OH)2-cholecalciferol;
with metabolites and analogues of vitamin D - increased risk of toxic effects; simultaneous use of these agents is possible only as an exception and only under control of the level of calcium in the blood plasma;
with antiepileptic drugs (phenytoin, phenobarbital), drugs for weight loss (orlistat) and lowering cholesterol levels, rifampicin - reduced absorption of cholecalciferol;
with cardiac glycosides - increased toxic effects of the latter (increased risk of cardiac arrhythmias); simultaneous use of these drugs should be carried out with caution;
with thiazides - increased risk of hypercalcemia; simultaneous use of these agents should be carried out with caution.
There is a possible antagonism between cholecalciferol and drugs prescribed for hypercalcemia, such as calcitonin, etidronate, and pamidronate.
Application features
Individual provision of vitamin D needs should take into account all possible sources of this vitamin.
Determining a child's daily need for vitamin D and the method of its use should be established individually and verified during periodic examinations, especially in the first months of life.
Combination therapy with vitamin D or calcium should be carried out only under the supervision of a physician and with monitoring of calcium levels in blood plasma and urine. It is not recommended to use cholecalciferol simultaneously with high doses of calcium.
Excessively high doses of the drug used for a long time, or loading doses, can cause chronic hypervitaminosis D3.
During use of the drug, monitoring of calcium, phosphate, and sugar levels in blood plasma and urine is recommended, and in the case of long-term treatment, monitoring of creatinine levels in blood plasma is recommended.
The drug should be used with caution in immobilized patients, patients with impaired renal function, cardiovascular diseases, and patients taking thiazides and cardiac glycosides simultaneously.
The drug should be used with special caution in infants born with a small anterior fontanelle.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no reports to date. However, it is recommended to exercise extreme caution when driving or operating other machinery, given the possibility of developing adverse reactions from the nervous system.
Use during pregnancy or breastfeeding
During pregnancy, Koledan should not be used in high doses due to the possibility of teratogenic effects in case of overdose.
Vitamin D passes into breast milk, so during breastfeeding the drug should be used only as prescribed by a doctor.
Method of administration and doses
The drug is intended for internal use. 1 drop contains 500 IU of vitamin D3. To accurately measure the dose, hold the bottle at a 45-degree angle while instilling. Adults and older children should take the drug in a spoonful of liquid. Infants should be given the drops in a spoonful of water, milk, or porridge. The drug should be added to food immediately before consumption.
Adults.
Prevention of rickets.
The recommended dose of the drug is 1 drop (about 500 IU of vitamin D3) per day.
Prevention of vitamin D3 deficiency in patients with malabsorption and high-risk patients without malabsorption disorders.
The recommended dose of the drug is 1 drop (about 500 IU of vitamin D3) per day.
Supportive treatment of osteoporosis.
The recommended dose of the drug is 2 drops (about 1000 IU of vitamin D3) per day.
Treatment of rickets and osteomalacia.
The recommended dose of the drug is 2-10 drops (1000-5000 IU of vitamin D3) per day. Duration of treatment is 1 year.
Treatment of hypoparathyroidism.
The recommended dose of the drug depends on the level of calcium in the blood serum and is 20-40 drops (about 10,000-20,000 IU of vitamin D3) per day. If higher doses of cholecalciferol are required, higher dosages of the drug should be used.
Children.
The drug should be used from the second week of life. During the second year of life, it may be necessary to continue using the drug, especially in winter. Prophylactic and therapeutic doses and duration of administration of the drug are determined individually by the doctor.
The total recommended dose for the prevention of rickets in premature infants is 2 drops (about 1000 IU of vitamin D3) per day.
The total recommended dose for treating vitamin D3 deficiency in children, including infants, is 2-10 drops (about 1000-5000 IU of vitamin D3) per day.
The duration of treatment depends on the course and severity of the disease and is determined by the doctor individually. Treatment of rickets and osteomalacia caused by vitamin D3 deficiency lasts for 1 year.
Children
The drug is used in children from 2 weeks of age.
Overdose
Symptoms.
Overdose of cholecalciferol causes hypercalcemia (occurs after the use of 50,000-100,000 IU of vitamin D3), hypercalciuria, renal calcifications and bone damage, as well as changes in the cardiovascular system.
Overdose is accompanied by the following effects: muscle weakness, loss of appetite, nausea, vomiting, constipation, polydipsia, polyuria, drowsiness, photosensitivity, pancreatitis, rhinorrhea, hyperthermia, decreased libido, conjunctivitis, hypercholesterolemia, increased transaminase activity, arterial hypertension, cardiac arrhythmia and uremia. Common symptoms are: pain in muscles and joints, headache, weight loss. Renal dysfunction develops with albuminuria, erythrocyturia and polyuria, increased potassium loss, hyposthenuria, nocturia and moderate increase in blood pressure. In severe cases, corneal opacity is possible, less often - swelling of the optic nerve papilla, inflammation of the iris up to the development of cataracts.
Kidney stones and calcification of soft tissues such as blood vessels, heart, lungs, and skin may occur. Rarely, cholestatic jaundice develops.
In case of overdose, the drug should be discontinued. Depending on the degree of hypercalcemia, a low-calcium or calcium-free diet, plenty of fluids, forced diuresis induced by the administration of furosemide, and the administration of glucocorticoids and calcitonin are recommended.
In case of normal kidney function, calcium levels are significantly reduced by intravenous sodium chloride (3-6 liters over 24 hours) with the addition of furosemide; in some cases, 15 mg/kg/hour of sodium edetate should also be used, with constant monitoring of calcium levels and ECG. In oligoanuria, on the contrary, hemodialysis is necessary. There is no specific antidote.
Adverse reactions
Side effects are usually not observed when taken in recommended doses. In case of individual hypersensitivity to the drug, which is rarely observed, or as a result of using too high doses for a long period, hypervitaminosis D may occur.
Metabolism and nutrition disorders: hypercholesterolemia, weight loss, polydipsia.
Mental: depression, decreased libido, mental disorders.
From the nervous system: headache, drowsiness.
From the organs of vision: conjunctivitis, photosensitivity.
From the cardiovascular system: arrhythmia, hypertension.
On the part of the digestive tract: loss of appetite, nausea, vomiting, constipation, dry mouth, flatulence, abdominal pain, diarrhea, dyspepsia, pancreatitis.
Liver and biliary tract: increased activity of aminotransferases.
Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including urticaria, rash, itching and anaphylactoid reactions (due to the content of benzyl alcohol in the preparation).
Musculoskeletal and connective tissue disorders: myalgia, arthralgia, muscle weakness.
On the part of the kidneys and urinary tract: increased calcium levels in the blood and/or urine, urolithiasis and tissue calcification, uremia, polyuria.
General disorders: increased sweating.
There have also been reports of rhinorrhea and hyperthermia.
Expiration date
3 years.
After opening the bottle, the drug can be used for 6 months.
Storage conditions
Store at a temperature not exceeding 25 ºС in the original packaging and out of the reach of children.
Packaging
10 ml of solution in an amber glass dropper bottle with a dropper; 1 bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
WORLD MEDICINE ILACH SAN. VE TIJ. A.Sh. / WORLD MEDICINE ILAC SAN. VE TIC. AS
Location of the manufacturer and its business address
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey / 15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.
