D3 40000

Generic

Colecalciferol [Vitamin D3]

 

Indications

D3® is indicated for the prevention and treatment of colecalciferol (Vitamin 03) 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

 

Pharmacology

Colecalciferol (Vitamin D3) aids in calcium and phosphorus absorption and reabsorption. Vitamin D3 is required for optimal bone growth and density maintenance. It also helps type 2 diabetes patients maintain optimal insulin levels by reducing the severity of bacterial infection, improving lung function, reducing the risk of cancer (breast, colorectal), and preventing cancer (breast, colorectal).

 

Dosage & Administration

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.

 

Interaction

Phenytoin, barbiturates, glucocorticoids, certain laxatives (such as liquid paraffin), actinomycin, and imidazole antifungal medicines are all affected.

 

Contraindications

It's not recommended for people who have a history of Vitamin D3 hypersensitivity.

 

Side Effects

Hypercalcaemia, hypercalciuria, skin rash, pruritus, urticaria, nausea, and abdominal pain are the most common adverse effects.

 

Pregnancy & Lactation

Studies have showed that dosages up to 4000 IU are safe to use during pregnancy. The recommended daily consumption for pregnant women is 400 IU; however, if the woman is Vitamin D3 deficient, a larger amount may be necessary. Women should follow their doctor's advise during pregnancy because their needs may change depending on the severity of their disease and how well they respond to therapy.

Breast milk excretes vitamin D3 and its metabolites. Overdose in nursing mothers' newborns has not been reported; however, when providing more vitamin D3 to a breast-fed child, the practitioner should take into account the dose of any additional vitamin D3 given to the mother.

 

Precautions & Warnings

In patients with compromised renal function, it should be used with caution.

 

Therapeutic Class

Vitamin in bone formation, Vitamin-D preparations

 

Storage Conditions

Keep the temperature below 30°C and keep it away from light and moisture. Keep out of children's reach.

 

Pharmaceutical Name