Posology: Dietary intake of vitamin D and sun exposure vary among patients and should be taken into account when calculating the appropriate dose of vitamin D analogue drugs such as calcifediol. The dose, frequency and duration of the treatment will be determined according to plasma levels of 25-OH-cholecalciferol, type and condition of the patient and other comorbidities such as obesity, malabsorption syndrome, treatment with corticosteroids. The dose to be administered should produce serum calcium levels between 9-10 mg/dl.
Determination of 25-OH-cholecalciferol in plasma is considered the most accepted way to diagnose vitamin D deficiency. It is accepted that Vitamin D deficiency exists when serum levels of 25-OH-cholecalciferol are <20 ng/ml, while insufficiency of vitamin D exists when serum levels of 25-OH-cholecalciferol are between 20 and 24 ng/ml.
In normal subjects mean serum concentrations are between 25 and 40 ng/ml of 25-OH-cholecalciferol.
The recommended dose is one capsule (0.266 mg of calcifediol) once a month.
Vitamin D insufficiency: Administration of one capsule (0.266 mg of calcifediol) per month for 2 months is recommended.
Vitamin D deficiency: Initial administration of one capsule (0.266 mg of calcifediol) per month for 4 months is recommended.
As adjuvant for the treatment of osteoporosis in patients with vitamin D deficiency: Administration of one capsule (0.266 mg of calcifediol) per month for 3-4 months is recommended.
In populations at high risk of vitamin D deficiency administration of higher doses or with longer duration might be necessary, after analytical verification of the extent of the deficiency and under regular monitoring of serum levels of 25-OH-cholecalciferol.
Renal osteodystrophy: One capsule (0.266 mg of calcifediol) weekly or biweekly.
Bone diseases induced by corticosteroid medications: One capsule (0.266 mg of calcifediol) monthly.
Patients with higher vitamin D deficiencies or malabsorption syndrome: Repetition of the initial dose a week after starting the treatment, followed by one capsule once a month for four months, controlling plasma concentration of 25-OH-cholecalciferol. Depending on these levels an increase in dose or frequency of administration might be required. Once the value is stabilized within the range either the therapy should be discontinued or the pattern spaced.
In general terms, doses should be reduced when the symptoms improve since the requirements of analogous drugs to vitamin D usually lessen after bone recovery.
It is convenient to check serum concentrations of 25-OH-cholecalciferol after 3 months of supplementation in order to confirm that they are within the desired or preferred range (30-60 ng/ml). Once the value is stabilized within this range the treatment should be discontinued or the frequency of administration should be lowered.
Paediatric population: For use in children, other presentations with lower dose strength are recommended.
Method of administration: Oral administration.
The capsule may be taken with water, milk or juice.