Prescribing Details
Description
Composition
D3® 2000 Tablet: Each coated tablet contains Colecalciferol (Vitamin D3) BP 2000 IU.
D3® 20000 Capsule: Each capsule contains Colecalciferol (Vitamin D3) BP 20000 IU.
D3® 40000 Capsule: Each capsule contains Colecalciferol (Vitamin D3) BP 40000 IU.
D3® Oral Solution: Each ml contains Colecalciferol (Vitamin D3) BP 200 IU.
D3® Injection: Each 1 ml ampoule contains Colecalciferol (Vitamin D3) BP 200000 IU.
Pharmacology
D3® is the preparation of Colecalciferol which is a synthetic form of Vitamin D3. The principal action of Vitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption. Vitamin D3 is essential for normal bone growth and development and to maintain bone density. It is also necessary for utilization of both calcium and phosphorus. Vitamin D3 acts as a hormone and increases reabsorption of calcium and phosphorus by the kidney.
Uses
Use in children and adolescent
The guideline for children and adolescent is given in dose and administration.
Indications
D3® is indicated for the prevention and treatment of colecalciferol (Vitamin D3) deficiency of the following conditions-
- Bone disorders (such as rickets, osteomalacia)
- Prevent bone loss (such as osteoporosis)
- Low levels of calcium or phosphate caused by certain disorders (such as hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia and tetany caused by hypocalcaemia)
- During kidney disease to keep calcium levels normal and allow normal bone growth
- During pregnancy (6th or 7th month) and breastfeeding, an essential nutrient for a growing infant
- Pre-eclampsia during pregnancy
- Menopause
Dosage and administration
Route of administration: D3® can be taken in oral and parenteral route.
D3® Capsule and Tablet
Adult
Treatment of vitamin D3 deficiency: D3® Capsule 40000 IU/week for 7 weeks, followed by maintenance therapy D3® Tablet 1400-2000 IU/day for the next 3 to 4 months until target level of vitamin D3 is achieved.
Prevention of vitamin D3 deficiency: D3® Capsule 20000 IU/ month, or as directed by the physician.
Children (12- 18 years)
Treatment of vitamin D3 deficiency: D3® Capsule 20000 IU once every 2 weeks for 6 weeks. Prevention of vitamin D3 deficiency: D3® Capsule 20000 IU once every 6 weeks.
D3® Oral Solution
Up to one year: 400 IU once a day or as directed by the physician.
1 year to 18 years: 600 IU once a day or as directed by the physician.
D3® Injection
Injectable solution can be administered through IM or oral route.
For treatment:
| Disease | Dosages |
|---|---|
| Rickets | 1 ampoule every 2 weeks for one month then 1 ampoule for every 4 months |
| Osteoporosis | 1 ampoule every 2 weeks for 3 months |
| Osteomalacia | 1 ampoule every 2 weeks for 3 months |
| Tetany caused by hypocalcaemia | 1 ampoule for every 4 months which may be increased to 2 ampoules |
| Menopause | 1 ampoule for every 6 months |
| Vitamin D3 deficiency | 1 ampoule can be repeated 1 to 6 months later |
For prevention:
| Period | Dosages |
|---|---|
| Pregnancy | 1/2 ampoule at 6th or 7th months |
| During breastfeeding | 1/2 ampoule for every 6 months |
| Children up to 5 years | 1 ampoule for every 6 months |
| Adolescent | 1 ampoule for every 6 months |
| Elderly | 1/2 ampoule for every 3 months |
| Direction of use | |
|---|---|
| For oral use | For lM use |
|
Step-1: Place the thumb on ampoule and break the upper narrow part of the ampoule. Step-2: Pour out the solution of the ampoule in a spoon. Step-3: Mix the solution with water or milk before oral use. |
Step-1: Place the thumb on ampoule and break the upper narrow part of the ampoule. Step-2: Then use as IM injection. |
Use in pregnancy & lactation
It can be prescribed during pregnancy and lactation if necessary.
Precautions
People with the following conditions should exercise with caution when considering taking vitamin D3 supplements: high blood calcium or phosphorus level, heart problems and kidney disease. Vitamin D3 must be taken with adequate amounts of both calcium and magnesium supplementation.
Side effects
Contraindications
Colecalciferol is contraindicated in all diseases associated with hypercalcaemia. It is also contraindicated in patients with known hypersensitivity to colecalciferol and any components of the product. It is also contraindicated if there is vitamin D toxicity.
Drug interactions
Drug interaction with medication: Concomitant treatment with phenytoin or barbiturates can decrease the effect of vitamin D because of metabolic activation. Concomitant use of glucocorticoids can decrease the effect of vitamin D. The effects of digitalis and other cardiac glycosides may be accentuated with the oral administration of calcium combined with vitamin D. Strict medical supervision is needed and, if necessary monitoring of ECG and calcium. Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D. The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1, 25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
Drug interaction with food and others: Not applicable.
Overdose
Preparation
No Data
Pharmaceutical precautions
Storage
D3® Capsule, Tablet, Injection: Store in a cool and dry place protected from light. Keep away from the reach of children.
D3® Oral Solution: Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.
Presentation
No Data
Package quantities
D3® 2000 Tablet: Carton of 30 tablets in blister pack.
D3® 20000 Capsule: Carton of 10 capsules in blister pack.
D3® 40000 Capsule: Carton of 12 capsules in blister pack.
D3® Oral Solution: Carton of 15 ml amber glass bottle.
D3® Injection: Carton of 1 ampoule in plastic tray.
