COLECALCIFEROL = VITAMIN D3 oral
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 deficienciesChild < 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 -