Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
Pharmacotherapeutic group: Vitamin supplements
ATC-code: A11CC05
Vitamin D increases the intestinal absorption of calcium and phosphate.
Administration of vitamin D3 counteracts development of rickets in children and osteomalacia in adults. It also counteracts the increase of parathyroid hormone (PTH) which is caused by calcium deficiency and which causes increased bone resorption.
In addition to bone and intestinal mucosa many other tissues have vitamin D receptors, to which the active hormonal form of vitamin D, calcitriol, binds.
Vitamin D is easily absorbed in the small intestine.
Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then further converted in the kidneys to 1,25-dihydroxycolecalciferol. 1,25-dihydroxycolecalciferol is the active metabolite responsible for increasing calcium absorption. Vitamin D, which is not metabolised, is stored in adipose and muscle tissues.
Vitamin D is excreted in faeces and urine.
At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is no further information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.
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