Cholecalciferol [Vitamin D3]
Dosage Form: Capsule.
Vitamin D3 deficiency can occur in people whose exposure to sunlight is limited and in those whose diet is deficient in vitamin D3. Vitamin D3 is essential for the effective calcium and phosphate absorption required for healthy bones and teeth,preventing rickets, osteomalacia and osteoporosis. Vitamin D3 is also essential to prevent pre-eclampsia during pregnancy and breast feeding as it is an essential nutrient for a growing infant. Vitamin D3 has vital role on immunity boost up.
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.
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.
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, protected from light & moisture. Keep out of the reach of children.
Manufactured by: Square Pharmaceuticals Ltd.