Coledan
(Cholecalciferol)




COMPOSITION

1 ml of the drug contains

Active ingredient: cholecalciferol (vitamin D3) 15,000 IU.

Excipients: sucrose, benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate anhy-drous, polyoxyl 35 castor oil, tutti frutti aroma, purified water.

THERAPEUTIC INDICATIONS

Prevention and treatment of:

- vitamin D deficit, including in high risk groups (malabsorption, chronic diseases of the small in-testine, biliary liver cirrhosis, conditions after gastric and/or intestinal resection);

- rachitis and rachitis-like diseases;

- hypocalcemic tetany;

- osteomalation;

- metabolic osteopathy (hypoparathyrosis and pseudohypoparathyrosis).

Treatment of osteoporosis, including in postmenopause (as part of complex therapy).

CONTRAINDICATIONS

- hypersensitivity to vitamin D3 and other components of the drug (especially to benzyl alcohol);

- hypervitaminosis D;

- increased blood and urine calcium levels;

- urinary stone disease (formation of calcium oxalate stones in kidneys);

- sarcoidosis;

- renal failure.

Exercise caution administering the drug in immobilized patients; during treatment with thiazides and cardiac glycosides; during pregnancy and lactation; in infants predisposed to early closure of fontanels (when small dimensions of the front vertex are determined at the birth).

ADVERSE EFFECTS

No side effects are observed in administration of the drug in the recommended doses.

Symptoms of hypervitaminosis D may develop in cases of rare individual hypersensitivity to vitamin D3 or as a result of administration of excessive doses over a long period of time.

Symptoms of hypervitaminosis D: loss of appetite, nausea, vomiting; headache, muscle and joint pain; constipation; mouth dryness; polyuria; weakness; mental disturbances, including depression; loss of body weight; sleep disorders; fever; emergence of protein, leukocytes, and hyaline cylinders in urine; increase of blood calcium levels and its urinary excretion; renal, vascular and pulmonary calcinosis is possible. In case of emergence of hypervitaminosis D signs discontinue the drug, limit the intake of calcium and prescribe vitamins А, С and В.

DOSAGE AND ADMINISTRATION

Coledan is administered per os, dissolved in one spoonful of liquid (1 drop contains 500 IU of cholecalciferol). Infants take the drops with a spoonful of milk or porridge. Do not add the drops into the bottle or the plate, as in such cases administration of the whole dose cannot be ensured. The dose is determined individually, taking into consideration the amount of vitamin D administered by the patient with the diet and in medicines.

Preventive doses

The drug is prescribed to mature newborns aged 3-4 weeks to 2-3 years, receiving adequate care and staying outdoors for sufficient time, in a dose of 500-1000 IU (1-2 drops) daily.

The dose of the drug, prescribed to premature infants, starting from 7-10 days of age, twins and children living in unfavourable conditions, is 1000-1500 IU (2-3 drops) daily.

In summertime the dose may be reduced to 500 IU (1 drop) daily.

The dose prescribed to pregnant women is 500 IU (1 drop) daily during the whole period of pregnancy or 1000 IU (2 drops) daily starting from the 28 th week of pregnancy.

The dose prescribed in postmenopausal period is 500-1000 IU (1-2 drops) daily.

Therapeutic doses

In rachitis the drug is prescribed in a daily dose of 2000-5000 IU (4-10 drops) for 4-6 weeks depending on the severity of the disease (stage I, II or III) and the variant of the course of disease. In such cases control of the clinical state of the patient and his biochemical parameters (calcium, phosphorus levels, alkaline phosphatase activity in blood and urine) should be established. The initial dose is 2000 IU (4 drops) daily for 3-5 days, then, in case of good tolerance, the dose is increased to the individual therapeutic dose (usually up to 3000 IU (6 drops) daily. The daily dose of 5000 IU (10 drops) is prescribed only in cases of marked bone alterations. If necessary, the treatment course may be repeated after a week`s break. Treatment should be continued until a clear therapeutic effect is achieved, with the subsequent transition to the preventive dose of 500-1500 IU (1-3 drops) daily.

In case of rachitis-like diseases the dose of 20000-30000 IU (40-60 drops) daily is prescribed, depending on the age, body weight and severity of the disease and under control of blood biochemical parameters and the results of urine analysis. The treatment course is 4-6 weeks.

In postmenopausal osteoporosis (as part of complex therapy) the daily dose of 500-1000 IU (1-2 drops) is prescribed.

SPECIAL INDICATIONS

Prescribing the drug, take into consideration all possible sources of vitamin D.

Administration of the drug in children is possible under strict medical supervision; at the time of periodic examinations, especially during the first months of life, the dosage regimen should be ad-justed.

Long-term administration of Coledan in high doses or administration of the drug in loading doses may lead to chronic hypervitaminosis D3.

Do not administer Coledan and calcium in high doses.

Administering the drug in therapeutic doses establish control of blood and urine calcium levels.

PREGNANCY AND LACTATION

Do not use Coledan in high doses due to a possible teratogenic effect in case of overdose.

Exercise caution prescribing Coledan during lactation, as administration of high doses of the drug by the nursing mother may cause symptoms of overdose in the child.

MANUFACTURED FORM AND PACKAGE

Oral drops 10 ml in an amber glass bottle with a dropper plug and a screw protective cap, equipped with a safety ring.

1 bottle together with an enclosed leaflet in a carton box.

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