Properties
What is it?
International Nonproprietary Name - vit.D3 Trade Name - Coledan International Nonproprietary Name - Cholecalciferol Dosage Form - Drops for oral administration. Description: A clear, homogeneous solution, colorless or slightly yellowish. Composition 1 ml of the preparation contains: Active substance: Cholecalciferol (Vitamin D3) 15000 IU. Excipients: Sucrose, Benzyl alcohol, Citric acid monohydrate, Disodium phosphate anhydrous, Polyoxyl 35 castor oil, "Tutti-frutti" flavoring, Purified water. Pharmacotherapeutic Group A preparation regulating calcium and phosphorus metabolism Indications for Use Prevention and treatment of: - Vitamin D deficiency, including in high-risk groups (malabsorption, chronic small intestine diseases, biliary cirrhosis of the liver, post-gastric and/or intestinal resection conditions); - Rickets and rickets-like diseases; - Hypocalcemic tetany; - Osteomalacia; - Metabolic osteopathies (hypoparathyroidism and pseudohypoparathyroidism). Treatment of osteoporosis, including in the postmenopausal period (as part of complex therapy). Dosage and Administration Coledan is taken orally, dissolved in one spoonful of liquid (1 drop contains 500 IU of cholecalciferol). For infants, the drops are given with one spoonful of milk or porridge. It is not recommended to add the drops to a bottle or plate, as full dosage cannot be guaranteed in such cases. The dose is determined individually, taking into account the amount of vitamin D the patient receives from their diet and medicinal preparations. Prophylactic doses For full-term newborns from 3-4 weeks of age up to 3 years, with proper care and sufficient time spent outdoors, the preparation is prescribed at a dose of 500-1000 IU (1-2 drops) per day. For premature infants from 7-10 days of age, twins, and children living in unfavorable conditions, 1000-1500 IU (2-3 drops) per day are prescribed. In the summer period, the dose can be reduced to 500 IU (1 drop) per day. Pregnant women are prescribed 500 IU (1 drop) per day throughout the entire pregnancy or 1000 IU (2 drops) per day from the 28th week of pregnancy. In the postmenopausal period, the preparation is prescribed at 500-1000 IU (1-2 drops) per day. For the treatment of rickets-like diseases, 20000-30000 IU (40-60 drops) per day are prescribed, depending on age, body weight, and disease severity, under the control of biochemical blood parameters and urine analysis. Course of treatment: 4-6 weeks. For the treatment of osteoporosis in the postmenopausal period (as part of complex therapy), 500-1000 IU (1-2 drops) per day are prescribed. Contraindications - Hypersensitivity to vitamin D3 and other components of the preparation (especially benzyl alcohol); - Hypervitaminosis D; - Increased levels of calcium in blood and urine; - Urolithiasis (formation of calcium oxalate stones in the kidneys); - Sarcoidosis; - Renal failure. The preparation should be used with caution in patients who are immobilized; when taking thiazides, cardiac glycosides; during pregnancy and lactation; in infants with a tendency for premature closure of the fontanelle (when the small size of the anterior fontanelle is established from birth).