Treatment and / or prophylaxis of vitamin D deficiency

Oral use.

Pour the drops into a small spoon. The drops may be taken pure or mixed in a liquid or semi-liquid food. Do not heat or boil, or put in a food too hot. It is preferable not to put the drops in a bottle of water or milk because the product can be placed on the wall

· Vitamin deficiency in children

Prophylaxis: It is recommended for all infants and young children under present conditions of life in case of insufficient exposure to the sun (circulars, ministerial of 21 February 1963 and 6 January 1971); Because of the low content of vitamin D.

: Premature: 3 to 4 drops per day

From 0 to 24 months: with milk enriched with vitamin D: 2, with 3 drops per day, without milk enriched with vitamin D: 3 to 5 drops per day, with pigmented skin: 7 drops per day

2 to 3 drops per day with digestive pathology 2 to 6 drops per day receiving anti-convulsants 4 to 6 drops per day
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O Treatment 6 to 12 drops a day for 4-6 months or 12 to 24 drops a day for 1-2 months until normal calcium and phosphate levels are monitored by monitoring calcium To avoid an overdose. Do not exceed a total dose of 600 000 IU / year.

· Vitamin deficiency in pregnant women

O Prophylaxis 3 drops per day from the 6th or 7th month
· Vitamin deficiency in adults and the elderly

O Prophylaxis 2 to 3 drops per day

O Treatment: 6 to 60 drops per day until normal, serum calcium and phosphorus monitored, calcium to avoid overdose. Do not exceed a total dose of 600 000 IU / year.

Pharmacotherapeutic group: VITAMIN D, ATC code, A11CC05

(A: Digestive System and Metabolism)

The essential role of vitamin D is exerted on the intestine, increasing its capacity, absorbing calcium and phosphates and the skeleton, which it promotes mineralization (thanks to its direct actions on the Bone in formation and its indirect actions involving the intestine, parathyroids, and the already mineralized bone)

Not applicable.

· Known hypersensitivity to vitamin D

· Hypercalcemia, hypercalciuria, calcium lithiasis

To avoid overdose, take into account the total doses of vitamin D in combination with a treatment already containing this vitamin, or in case of use of milk supplemented with vitamin D.

In indications requiring strong and repeated doses, monitoring calcium and serum calcium and stopping the intake of vitamin D if serum calcium exceeds 106 mg / ml (2.65 mmol / l) or calcium in excess of 300 mg / L in adults or 4-6 mg / kg / d in children

Associations to be taken into account

+; Orlistat

Decreased absorption of vitamin D.

Not applicable.

Clinical signs

· Headache asthenia, anorexia, slimming, stunting

· Nausea, vomiting

· Polyuria, polydipsia, dehydration

· Hypertension

· Lithium calcium, tissue calcifications, in particular, renal and vascular

· Renal impairment

Biological signs

Hypercalcemia, hypercalciuria, hyperphosphataemia, hyperphosphaturia

What to do

Stop the administration of vitamin D. reduce calcium intake, increase diuresis, abundant drinks

If necessary, vitamin D may be prescribed during pregnancy and lactation. This supplementation does not replace the administration of vitamin D in the newborn.

Very rarely and in particular in case of overdose (see section on Overdose)

· Hypersensitivity reaction to cholecalciferol

· Hypercalcemia, hypercalciuria, calcium lithiasis

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the drug is important. It permits continuous monitoring of the benefit / risk ratio of the drug. Health professionals must report any adverse reactions suspected through the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and Network of Regional Centers for Pharmacovigilance. Ansm.sante.fr.

Treatment and / or prophylaxis of vitamin D deficiency