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1 ml (= 28 drops) contains cholecalciferol equivalent to 2800 IU.

Properties/Actions:

Vitamin D3, which is effective in therapeutic use when given orally, is a naturally occurring vitamin in humans, being formed from 7-dehydrocholesterol in the skin as a result of exposure to sunlight (ultraviolet radiation).

Dietary sources such as milk, butter, liver and egg yolk only contain small quantities of vitamin D.

Vitamin D regulates calcium and phosphate metabolism, its main function is synthesizing the carrier protein which mediates the intestinal calcium absorption by an active transport mechanism.

It also promotes the normal bone formation. The recommended daily allowance of vitamin D is 400 IU.

Pharmacokinetics:

	Vitamin D3 is rapidly absorbed from the small intestine and transported to its main storage sites (liver and adipose tissue) bound to a specific alpha-globulin.
	Vitamin D3 is biotransformed in the liver to 25-hydroxycholecalciferol (25-OHCC), which then undergoes further hydroxylation at position 1 in the kidneys to give the active metabolite 1,25-dihydroxycholecalciferol (1,25 - 2(OH) CC).
	Vitamin D is stored in the body and is excreted mainly in the form of inactive glucuronides. It is excreted both in stool (via the bile) and in urine.

Indications/Uses:

	Prevention & Treatment of rickets & osteomalacia.
	Hypocalcaemic tetany.
	Hypoparathyroidism.

Dosage/Administration:

	Prevention of rickets:
	Full-term infants: 400 IU (= 4 drops) daily in the first year of life, starting in week 2-5. Preterm infants: 400-800 IU (=4-8 drops) daily in the first year of life.

	Treatment of rickets & osteomalacia
	“Dosage should be individualized on the basis of frequent determinations of serum calcium and bone X-rays to avoid hypervitaminosis”: Treatment is started with 1000 to 5000 IU (=10 - 50 drops) daily for 3 weeks, then followed by a maintenance dose which is the same as that for prevention of rickets (i.e. 400 IU = 4 drops daily).

	In acute postoperative hypoparathyroidism & acute tetany:
	Treatment should be started by I.M. injection, in combination with slow I.V. calcium injection as necessary - depending on the patient’s calcium blood level - then oral maintenance therapy is achieved by Vidrop 400 IU (= 4 drops).

	You may add the required number of drops to food or drink.

Contraindications:

To use of Vi-De 3 for rickets prevention in infants: hypothyroidism, idiopathic hypercalcaemia, vitamin-D hypersensitivity. To high-dose vitamin-D therapy in adults: skeletal disorders involving complete immobilization (which increases calcium excretion). Sarcoidosis (Boeck’s disease), acute pulmonary tuberculosis, immobilization following corrective orthopaedic surgery. Vi-De 3 should not be given by intravenous injection. Concomitant administration of vitamin-D analogues.

Precautions:

	Caution is required in patients with disturbances of calcium metabolism, kidney failure, kidney stones, arteriosclerosis or coronary disease. All forms of vitamin D are toxic in high doses, causing a significant increase in calcium absorption. Toxic effects may also occur if doses of 1000-3000 IU/kg bodyweight daily are administered over a period of several months. The fact that milk, fats and baby or other foods are often enriched with vitamin D should be taken into account when determining dosage. Caution should be exercised in patients receiving treatment with cardiac glycosides since hypercalaemia may lead to arrhythmia in such cases. Particular care should be taken to avoid the following:
	Prophylactic administration of vitamin D in large doses over a period of months or even years without proper monitoring or a specific indication, especially in conjunction with calcium and/or vitamin-enriched foods (e.g. babyfood). Massive doses of vitamin D at short intervals. This is because the body’s attempts to eliminate the resultant calcium excess might overload the excretory capacity of the kidneys; the first symptoms of overdose are polyurea and polydipsia. Patients receiving the recommended dose of Vi-De 3 for the prevention of rickets or osteomalacia or as a supplement to the normal diet should avoid other drugs containing vitamin D and vitamin-D enriched foods. Particular care should be exercised in the prophylactic use of vitamin-D preparations in infants receiving vitamin-D enriched babyfoods (normally containing 400 IU per daily portion). The recommended dose should be taken regularly but not exceeded. Care should be taken that patients receive sufficient dietary calcium. Regular blood calcium checks should be performed on patients receiving long-term treatment for vitamin-D-resistant rickets.
	Pregnancy and Lactation: Vi-De 3 may be taken by women who are pregnant or breastfeeding at a dosage corresponding to the normal daily requirement. There is clear evidence that doses in excess of the daily requirment represent a risk to the foetus, although this may be outweighed by the therapeutic benefit to the mother.

Adverse Reactions:

Sudden falls in blood pressure and shock-like reactions may occur with the injectable from due to the PEG-40 castor oil it contains. Patients should therefore be monitored for some time following i.m. administration.

Interactions:

Colestyramine, colestipol and mineral oils may reduce the intestinal absorption of vitamin D and as long an interval as possible (at least 4 hours) should therefor be allowed between ingestion. Concomitant administration thiazide diuretics may lead to hypercalcaemia, possibly necessitating the withdrawal of Vi-De 3. Phenobarbital and phenytoin (and presumably other liver-enzyme-inducing agents) may cause a reduction in plasma levels of cholecalciferol. Corticosteroids may lessen the effect of cholecalciferol. Concomitant administration with cardiac glycosides may result in cardiac arrhythmia.

Overdosage:

If vitamin D overdosage exceeds the excretory capacity of the kidneys, calcium deposits may be formed in the kidneys and vascular walls. The signs and symptoms of overdosage are thirst, polyuria, loss of appetite, nausea, vomiting, constipation, headach, joint pain, muscle weakness, dehydration (especially wizened, dry skin in children)tremor affecting the extremities, muscular atrophy with fibrillary contractions and hypertension. These symptoms are reversible provided vitamin D is withdrawn in time.

Management:

Immediate discontinuation of all vitamin D intake, increase of fluid intake and avoidance of calcium-rich foods. Additionally in severe cases prednisolone 25mg i.v. then 10 mg. day by month.

Other Information:

Store oral solution at a temperature below 30°C.