COLECALCIFEROL = VITAMIN D3 oral

Prescription under medical supervision


Therapeutic action

– Vitamin necessary for the intestinal absorption of calcium and phosphate and for normal bone calcification

Indications

– Prevention and treatment of vitamin D deficiencies (rickets, osteomalacia)

Forms and strengths

– 10 000 IU/ml oral solution, in 10 ml vial
– 50 000 IU/ml oral solution, in 2 ml ampoule (100 000 IU)

Dosage and duration

Colecalciferol and ergocalciferol are used at the same doses:

– Prevention of vitamin D deficiencies
• Term neonate: 400 to 800 IU once daily until 6 months of age
• Term neonate in contexts of high prevalence of vitamin D deficiency: 600 to 1200 IU once daily until 6 months of age
• Pregnant woman: 100 000 IU single dose (one 2 ml ampoule) in the 6th or 7th month of pregnancy 

– Treatment of vitamin D deficiencies
Child < 3 months: 2 000 IU once daily for 3 months
Child from 3 to < 12 months: 2 000 IU once daily for 3 months or 50 000 IU single dose 
Child from 12 months to < 12 years: 3 000 to 6 000 IU once daily for 3 months or 150 000 IU single dose 
Child ≥ 12 years and adult: 6 000 IU once daily for 3 months or 300 000 IU single dose 
Then continue with preventive dose, as long as the situation requires:
Child < 12 months: 400 IU once daily 
Child ≥ 12 months and adult: 600 IU once daily

– Do not exceed 600 000 IU yearly.

Contra-indications, adverse effects, precautions

– Do not administer to patients with hypercalcaemia, hypercalciuria, calcic lithiasis, severe renal impairment.
– Stop treatment if signs of overdosage occur: headache, anorexia, nausea, vomiting, increased thirst, polyuria.
– Avoid combination with thiazide diuretics, e.g. hydrochlorothiazide (decreased urinary calcium excretion).
– Monitor, if possible, calcaemia and calciuria during curative treatment.
– Pregnancy: no contra-indication
– Breast-feeding: no contra-indication. When curative treatment is being administered to the mother, do not give vitamin D to the child.

Remarks

– The number of IU per drop of oral solution varies according to manufacturers. Check instructions for use.
– Preferably use the vials of oral solution that, once opened, keep for 6 months.
– During the first 3 months of curative treatment, administer a supplement of 500 mg of calcium once daily.
–  Storage: below 25 °C -