IBN SINA PHARMACEUTICALS LTD.
CHOLECALCIFEROL [VITAMIN D3]
Colecalciferol (Vitamin D3) is indicated in the treatment & prevention of Vitamin D3 deficiency. It is also indicated as an adjunct to specific therapy for osteoporosis in patients with vitamin D3 deficiency.
Vitamin in bone formation, Vitamin-D preparations
Colecalciferol (Vitamin D3) helps for the absorption & reabsorption of Calcium & Phosphorous. Vitamin D3 is essential for normal bone growth & to maintain bone density. It also reduces the severity of bacterial infection, improves lung function, prevents the risk of cancer (breast, colorectal) & helps to maintain adequate insulin levels for type 2 diabetes patients.
For capsule: Adults: Treatment of Vitamin D3 deficiency: 40000 IU once weekly for 7 weeks. Doses for maintenance therapy is 1400-2000 IU/day. To confirm the target level of 25 hydroxyvitamin D, measurement of it should be determined 3-4 months after initiating the maintenance therapy. Prevention of Vitamin D3 deficiency: 20000 IU every 4 weeks. Higher doses may be required in certain situations. Addition to specific therapy for osteoporosis: 20000 IU once a month. For capsule: Children (12-18 years): Treatment of Vitamin D3 deficiency: 20000 IU once every 2 weeks for 6 weeks. Prevention of Vitamin D3 deficiency: 20000 IU every 6 weeks. For film-coated tablet: 1000 IU (1-2 tablets) daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. For oroflash or chewable tablets: 1000 IU to 2000 IU daily, or as directed by physician. Take the medicine with food or within 1 hour after a meal. Place the tablet in mouth swallow after chewing. For Syrup: For patients with risk of Cholecalciferol deficiency: 0-1 yr: 400 IU/ day (2 ml) >1 Yr: 600 lU/ day (3 ml) For Cholecalciferol deficient patients: 0-1 yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks 1 -18 yrs: 2000 IU/ day for 6 weeks. Injection: Prevention: Infants receiving Vitamin D enriched milk: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 6 months. Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months. Adolescents: 1 ampoule (1ml) i.e. 2,00000 I.U. every 6 months during winter. Pregnancy: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. from the 6th or 7th month of pregnancy. Elderly: 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. every 3 months. Digestive disorders, concomitant treatment with antiepileptics & other particular condition not described above; 1/2 ampoule (0.5ml) i.e. 1,00000 I.U. or 1 ampoule (1ml) i.e. 2,00000 I.U. every 3 or 6 months. Injection: Vitamin D deficiency: 1 ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.
It interferes with phenytoin, barbiturates, glucocorticoids, certain laxative (such as liquid paraffin), actinomycin and imidazole antifungal agents.
It is contraindicated in patients with known hypersensitivity to Vitamin D3.
The general side effects are hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, abdominal pain.
Studies have shown safe use of doses up to 4000 IU during pregnancy. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment Vitamin D3 and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed; however, when prescribing additional vitamin D3 to a breast-fed child the practitioner should consider the dose of any additional vitamin D3 given to the mother.
It can lead to hypervitaminosis D.
It should be used with caution in patients with impaired renal function.
Keep below 308 C temperature, protected from light & moisture. Keep out of the reach of children.