A yellow hard gelatin capsule print D3 1,000 on capsule containing white powder.
Each capsule contains Dry vitamin D3 100 CWS (100,000 I.U./g) 10 mg eq to Cholecalciferol 1,000 I.U.
Pharmacology: Pharmacodynamics: Mode of action: A major hormonal actions of vitamin D is to maintain serum calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism. The interaction of 1,25(0H)2 D with its vitamin D receptor (VDR) in the small intestine increases the efficiency of intestinal calcium absorption from approximately 10-15% up to 30-40% and intestinal phosphorus absorption from approximately 60% to 80%. In the kidneys, 1,25(OH)2D stimulates calcium reabsorption from the glomerular filtrate.
Pharmacokinetics: Cholecalciferol are well absorbed from the gastrointestinal tract, enters the circulation on chylomicrons first and it is only slowly transferred to the specific plasma binding protein (DBP). Vitamin D3 is mainly bound to DBP. The consequence of chylomicron transport of dietary vitamin D is the possibility of uptake by peripheral tissues, such as adipose tissue and muscle, due to the action of lipoprotein lipase. The 25-hydroxylase enzyme in the liver converts vitamin D into 25(OH)D which quickly enters the plasma pool that constitutes the predominant pool, then it is carried to the kidney where to be transformed into active form 1,25-dihydroxycholesterol (calcitriol) by 1-a-hydroxylase enzyme.
Treatment and prevention of vitamin D insufficiency and deficiency in adult.
As an adjunct to specific therapy for osteoporosis, reduce the risk of fracture incidence in the elderly.
Recommended Dose: Take 1 capsule (1,000 IU) once a day or as doctor directed.
Mode of Administration: Take orally after a meal.
Symptomatic vitamin D intoxication is extremely rare but can be caused by inadvertent or intentional ingestion of excessively high doses. Doses of more than 50,000 IU per day raise levels of 25-hydroxyvitamin D to more than 150 ng per milliliter (374 nmol per liter) and are associated with hypercalcemia and hyperphosphatemia.
Treatment of vitamin D analog intoxication consists of withdrawal of both the Calciferol Vitamin D3 1,000 IU and calcium supplements, maintenance of a low-calcium diet to decrease serum calcium concentrations, administration of oral or IV fluids and, if needed, corticosteroids or other drugs, particularly calciuric diuretics (e.g., furosemide and ethacrynic acid) to decrease serum calcium concentrations.
Hypersensitivity to the active substance or to any of the excipients. Patients with hypercalcemia or metastatic calcification.
Drug may accumulate in the body to cause danger, therefore, it should not be used more than recommended dose or used consecutively a long time.
It also should be used as prescribed and recommended by a doctor.
Pregnancy: Safe use of cholecalciferol during pregnancy has not been established. But it was found that pregnancy with hypercalcemia for a long time, the infants may be aortic valvular stenosis, retinophathy, and mental and/or physical retardation. Hypercalcemia during pregnancy causes low parathyroid hormone concentrations in the neonate resulting in hypocalcemia, tetany, and seizures.
Lactation: Safe use of cholecalciferol during lactation has not been established. Large doses of vitamin D analogs should not be administered to nursing women.
Weakness; headache; somnolence; nausea; vomiting, dry mouth; constipation; muscle pain; bone pain; metallic taste; pruritus.
Antacids: Hypermagnesemia may develop in patients on chronic renal dialysis.
Digitalis glycoside: Hypercalcemia in patients on digitalis may precipitate cardiac arrhythmias.
Verapamil: Atrial fibrillation has occurred when supplemental calcium and calciferol have induced hypercalcemia.
Cholestyramine: Intestinal absorption of vitamin D may be reduced.
Ketoconazole: Ketoconazole may inhibit both synthetic and decay of vitamin D calcitriol.
Mineral oil: Absorption of vitamin D is reduced with prolonged use of mineral oil.
Phenytoin, Phenobarbital: Endogenous synthesis of calcitriol will be inhibited. Higher doses of calcitriol may be required, if patients receive this medicine at the same time.
Thiazide diuretics: Hypoparathyroid patients who receive vitamin D that may have hypercalcemia due to Thiazide diuretics.
Storage Condition: Store below 30°C.
A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Calciferol Vitamin D3 1,000 IU hard cap 1,000 IU
3 × 10's