Generics: Cholecalciferol [Vitamin D3]
Dosage Form: Tablet.
Vitamin D3 insufficiency can be treated and prevented with colecalciferol (Vitamin D3). In patients with vitamin D3 deficiency, it can also be used as a supplement to particular osteoporosis treatment.
The active form of Vitamin D3, Calcitriol, exerts its effect by binding to the Vitamin D receptors (VDRs) which are widely distributed through many body tissues.Vitamin D3 has a half life of about 50 days as it is fat soluble.Vitamin D3 is absorbed in the small intestine and bound to specific a-globulins and transported to the liver where it is metabolised to 25-hydroxy Vitamin D3 (Calcidiol). A second hydroxylation to 1,25-dihydroxy Vitamin D3 (Calcitriol) occurs in the kidney. This metabolite is responsible for the vitamin’s ability to increase the absorption of calcium. Non-metabolised Vitamin D3 is stored in tissues such as fat and muscle.Vitamin D3 is eliminated via faeces and urine.
Prsecribed by physicians.
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.
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 patients with risk of Cholecalciferol deficiency:
- yr: 400 IU/ day (2 ml)
- >1 Yr: 600 lU/ day (3 ml)
- For Cholecalciferol deficient patients:
- yr: 2000 IU/ day (+50000 IU/week ) for 6 weeks
- -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:
- ampoule (1ml) i.e. 2,00000 I.U. which can be repeated 1 to 6 months later. Or, as directed by the registered physician.
Route of administration: Orally.
Many drugs cause Vitamin D3 deficiencies because they interfere with the absorption and metabolism of Vitamin D3 and includes Magnesium containing Antacids, Digoxin, Thiazide Diuretics, Cholestyramine, Cholistipol, Phenytoin, Phenobarbital, Orlistat,and Mineral Oil. Also, Corticosteroids, such as Prednisolone increase the need for Vitamin D3.
Vitamin D3 is contraindicated in all diseases associated with hypercalcaemia. It is also contraindicated in patients with known hypersensitivity to Vitamin D3 (or medicines of the same class) and any of the excipients. It is contraindicated if there is evidence of Vitamin D3 toxicity.
Symptoms rarely include anorexia, lassitude, nausea & vomiting, diarrhea, constipation, weight loss, polyuria, sweating, headache, thirst, vertigo, and raised concentrations of calcium and phosphate in plasma and urine.
Pregnancy & Lactation:
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.
Precautions & Warnings:
Plasma-calcium concentration should be monitored at intervals in patients receiving high doses of Vitamin D3, in renal impairment, and during pregnancy & lactation. People using Digoxin and Thiazide Diuretics should consult a health care practitioner before supplementing with Vitamin D3. People with liver or kidney disease, primary hyperthyroidism, lymphoma, tuberculosis and granulomatous disease should consult a health care practitioner before supplementing with Vitamin D3.
The safety & efficacy of Vitamin D3 in children under 12 years have not been established.
Vitamin in bone formation, Vitamin-D preparations
Keep below 30º C temperature. Keep in a dry place, away from light and heat. Keep out of the reach of children.
Manufactured by: Aristopharma Ltd.