Composition:

Each Ampoule 1ml contains 2.5mg Colecalciferol (eq. to 100000 IU vitamin D3)

Indications:

For treatment and prevention of vitamin D3 deficiency due to malabsorption.

As an adjunct to specific therapy for osteoporosis in patients with vitamin D3 deficiency or at risk of vitamin D3 insufficiency. Vit- D3 is indicated for adolescents and adults.

Contraindications

• Hypersensitivity to the active substance (Colecalciferol) or to any of the excipients.
• Hypercalcaemia and/or hypercalciuria.
• Nephrolithiasis / Renal calculi.
• Hypervitaminosis.
• Severe renal impairment.

Warnings:

• Vit D3- should not be taken by patients with a tendency to form calcium containing renal calculi.
• During long-term therapy with Vit D3 the calcium levels in blood and urine should be monitored every 3 to 6 months, and the kidney function should be checked by measuring the serum creatinine.
• Caution is required in patients receiving treatment for cardiovascular disease cardiac glycosides including digitalis).
• Vit D3 should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of Vit D3 to its active form. These patients should be monitored with regard to the calcium content in serum and urine.
• Colecalciferol should not be used with dietary supplements containing Vit D3 or Calcium containing nutrients unless under close medical supervision to prevent hypercalcaemia.
• Paediatric population: Vit D3 should not be given to infants and children under the age of 12.

Interactions with other medicines:

• phosphorus infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the danger of metastatic calcification.
• Patients treated with cardiac glycosides may be susceptible to high calcium levels and should have ECG parameters and calcium levels monitored. It is recommended to reduce the dose or interrupt treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
• Simultaneous administration of benzothiadiazide derivatives (thiazide diuretics) increases the risk of hypercalcaemia because they decrease the calcium excretion in the urine. The calcium levels in plasma and urine should therefore be monitored for patients undergoing long-term treatment.
• If Colecalciferol is combined with its metabolites or analogues of vitamin D careful monitoring of serum calcium levels is recommended.
• Anti-convulsants e.g., phenytoin, phenobarbital, primidone may diminish the effect of colecalciferol due to hepatic enzyme induction.
• Rifampicin may impair the absorption of colecalciferol due to hepatic enzyme induction.
• Isoniazide may impair the absorption of colecalciferol due to inhibition of colecalciferol metabolism.
• Drugs leading to fat malabsorption, e.g. orlistat, liquid paraffin, cholestyramine, may impair the absorption of Colecalciferol.
• Concomitant use of glucocorticoids can decrease the effect of vitamin D.

Pregnancy and breastfeeding

Vitamin D3 should not be used during pregnancy unless the clinical condition of the woman requires treatment with colecalciferol, at a dose necessary to overcome the deficiency.

Overdose of vitamin D3 in pregnancy must be prevented since long-lasting hypercalcemia can lead to physical and mental retardation as well as to congenital heart and eye diseases of the child. Therefore, vitamin D3 may not be used during pregnancy and lactation.

If a vitamin D3 supplement should be required, a drug with a lower cholecalciferol content than this drug should be chosen. It is not recommended for use if you are breastfeeding as it may pinto breast milk.

Side effects

The side effects of vitamin D result from hypercalcemia due to overdose. Depending on dosage and duration of the therapy a severe and long-lasting hypercalcemia can appear with acute symptoms (arrhythmia, nausea, vomiting, psychic symptoms, and impaired consciousness) and chronic symptoms (polyuria, polydipsia, anorexia, weight loss, kidney stone formation, nephrocalcinosis, extraosseous calcifications). In individual cases lethal courses have been described.

Dosage and method of administration

 Adults

Prophylaxis due to malabsorption: ½ -1 ampoule (50 000 to 100 000 IU vitamin D) as a single dose in individual intervals (normal case: every 3 months). The serum calcium level should be monitored every 3 - 6 months and the dose should be adjusted according to the values. The treating doctor decides on the duration of treatment.

Type of application

The injection solution is injected deeply intramuscularly (IM).

Paediatric Population:

There is no expert knowledge with children.