ARISTO D3 (Cholecalciferol)

Therapeutic Group : Vitamins & Minerals

Presentation:

ARISTO D₃ 2000 Tablet: Each tablet contains Cholecalciferol BP (as Vitamin D3) 2000 IU.
ARISTO D₃ 20000 Capsule: Each capsule contains Cholecalciferol BP (as Vitamin D3) 20000 IU.
ARISTO D₃ 40000 Capsule: Each capsule contains Cholecalciferol BP (as Vitamin D3) 40000 IU.
ARISTO D₃ Oral & IM Injectable Solution: Each 1 ml ampoule contains Cholecalciferol BP (as Vitamin D₃) 200000 IU.

Indications:

Vitamin D₃ (Cholecalciferol) helps body to absorb calcium and phosphorus. It is used to treat and prevent bone disorders (such as rickets, osteomalacia). In combination with calcium it is used to treat or prevent bone loss (osteoporosis). It is also used with other medications to treat low levels of calcium or phosphate caused by certain disorders (such as hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia). It may be used in kidney disease to keep calcium levels normal and allow normal bone growth.

Dosage & Administration:

Use of Tablet & Capsule:

Group of Patien	Dosages
Adult	40000 IU/week for 7 weeks and followed by 2000 IU/day as maintenance therapy if required.
Child	20000 IU in every 2 weeks for 6 weeks

Preventive measures:

Curative treatment:

Group of Patien	Dosages
Adult	20000 IU/month
Child	20000 IU in every 6 weeks

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 hypocalcemia	1 ampoule for every 4 months which may be increased to 2 ampoules
Menopause	1 ampoule for every 6 months
Vitamin D deficiency	1 ampoule can be repeated 1 to 6 months later

Preventive measures:

Period	Dosages
Pregnacy	1/2 ampoule at 6th or 7th month
During Breast feeding	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

– Injectable solution can be administered through IM or Oral route – Prevention should be started early and continued to the 5th year of life

Contrainidications:

Cholecalciferol is contraindicated in all diseases associated with hypercalcaemia. It is also contraindicated in patients with known hypersensitivity to Cholecalciferol (or medicines of the same class) and any of the constituent excipients. Cholecalciferol is contraindicated if there is evidence of vitamin D toxicity.

Warning & Precautions:

People with the following conditions should exercise with caution when considering taking vitamin D₃ supplements:
– High blood calcium or phosphorus level
– Heart problems
– Kidney disease

Vitamin D₃ must be taken with adequate amounts of both calcium and magnesium supplementation.

Side effects:

Generally all nutritional supplements are considered to be safe and well tolerable. However, few side-effects can generally occur including hypercalcaemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcaemia), occasional acute symptoms include anorexia, headache, nausea, vomiting, abdominal pain or stomach ache and constipation with the administration of Cholecalciferol.

Use in special groups:

Use in pregnancy: There is no evidence to suggest that vitamin D₃ is teratogenic in humans even at very high doses. Cholecalciferol should be used during pregnancy only if the benefits outweigh the potential risk to the fetus.
Use in nursing mothers: It should be assumed that exogenous Cholecalciferol passes into the breast milk. In view of the potential for hypercalcaemia in the mother and for adverse reactions from
Cholecalciferol in nursing infants, mothers may breastfeed while taking Cholecalciferol, provided that the serum Calcium levels of the mother and infant are monitored.