• Generic name: Cholecalciferol (Vit. D3)
• Composition: Each 2 ml contains: Cholecalciferol (Vit. D3), equivalent to 300,000 I.U.
• Pharmaceutical form: Ampoule.
• Indications: Prophylaxis and / or treatment of vitamin D deficiency.
• Dose/ Mode of administration: IM route.

It is generally accepted that the prophylaxis of vitamin D deficiency should be systematic, in newborns and infants, in pregnant women (last trimester) and breast feeding women in the late winter and spring, in the elderly subjects, possibly in children and adolescents in case of insufficient sun exposure, in the following conditions:

• Non-exposure to sunlight or high skin pigmentation with unbalanced diet (low in calcium, vegetarian,…) or extended dermatological pathology or granulomatous disease (tuberculosis, leprosy …)
• Subjects under anticonvulsants (barbiturates, phenytoin, primidone)
• Subjects receiving long-term corticosteroids.
• Digestive pathology (intestinal malabsorption and mucoviscidosis)
• Hepatic insufficiency.

• Infant receiving milk fortified with vitamin D: ½ ampoule (150,000 IU) every 6 months.
• Breastfed infant or not receiving milk fortified with vitamin D and young children up to 5 years old: 1 ampoule (300,000 IU) every 6 months.
• Adolescent: 1 ampoule (300,000 IU) every 6 months during the winter.
• Pregnant woman: ½ ampoule (150,000 IU) in the 6th and 7th month of pregnancy, possibly repeated once after a month, when the last trimester begins in winter or in case of non-exposure to sunlight.
• Elderly subject- ½ ampoule (150,000 1U) every 3 months.
• Child or adult with digestive disorders: ½ to 1 ampoule (150,000 to 300,000 IU) every 3 months.
• Child or adult under anticonvulsive treatment: ½ to 1 ampoule (150, 000 to 300,000 IU) every 3 months.
• Child or adult in cases other than those listed above: 1 ampoule (300,000 1U) every 6 months.
• Treatment of vitamin D deficiency (rickets, osteomalacia, neonatal hypocalcemia): 1 ampoule (300,000 IU) possibly repeated once after 1 to 6 months.

Contraindications

• Hypersensitivity to one of the components, especially to vitamin D.
• Hypercalcemia, hypercalciuria, calcic lithiasis.

Pregnancy/ Lactation

• Pregnancy: There is no available teratogenesis study in animals. Clinically, a significant decline seems to exclude the effect of malformation or foetotoxicity of vitamin D, Accordingly, vitamin D may be described during pregnancy if needed.
• Lactation: In case of need, vitamin D may be described during breastfeeding.

Pharmacodynamics:

Vitamin D (digestive system and metabolism): The essential role of vitamin D is acting on the intestine, for which it increases the ability to absorb calcium and phosphate, and on the skeleton, for which it promotes mineralization (by virtue of its direct actions on bones information and its indirect actions involving the intestine, parathyroid and bone already mineralized).

• The vitamin D is absorbed in the small intestine in a passive way, then join the general circulation by lymphatic route, incorporated in chylomicrons.
• After absorption, it binds to a specific carrier protein and is transported to liver to be converted into 25-hydroxyvitamin which is connected in its turn to the same carrier protein and is transported to kidney where it is transformed to its active form, 1 25 dihydroxyvitamin D.
• Its essential storage sites are adipose tissues, muscles, but also the blood.
• The 4-hydroxyvitamin bound to its carrier protein is the major form of circulating reserve for vitamin D.
• Its half-life in blood is 15 to 40 days.
• The elimination of vitamin D and its metabolites is done by fecal route, in unprocessed form or in hydrosoluble form (calcitroic acid, glucoronide derivatives).