Vitamin D2 is a steroid derivative which controls the calcification of bones in both the young and old. Although naturally produced under normal conditions, pharmacological doses are often required in disease states.
Therapeutic Indications
- Simple vitamin D deficiency.
- Vitamin D deficiency caused by intestinal malabsorption or chronic liver disease .
- Hypocalcaemia of hypoparathyroidism.
Posology And Method Of Administration
In the treatment of Vitamin D deficiency conditions: 0.25 mg (10,000 units or one tablet) daily.
Vitamin D deficiency caused by intestinal malabsorption or chronic liver disease: usually requires doses of up to 1mg (40,000 units or 4 tablets) daily in divided doses.
In treatment of hypoparathyroidism: 1.25 mg to 5 mg (50,000 to 200,000 units) daily. The hypocalcaemia of hypoparathyroidism often requires doses of up to 5mg (200 000 units) daily in divided doses.
Patients with renal osteodystrophy: may require as much as 5mg (200,000 units) daily.
For children and the elderly: the adult dosage may require adjustment according to the severity of the condition. This medicine is taken by mouth.
Contraindications
Renal insufficiency, Hypercalcaemia, Evidence of vitamin D toxicity and metastatic calcification.
Special Warnings And Precautions For Use
Vitamin D should be administered with caution to infants and patients who may have an increased sensitivity to its effects.
Use with care in patients with renal impairment, renal calculi or heart disease or arteriosclerosis who might be at increased risk of organ damage if hypercalcaemia were to occur.
All patients receiving pharmacological doses of vitamin D should have their plasma calcium concentration checked at intervals and whenever nausea and vomiting are present.
Patients with rare hereditary problems of galactose intolerance, fructose intolerance, glucose-galactose malabsorption, the Lapp-lactase deficiency or sucrase-isomaltase insufficiency should not take this medicine. Adequate fluid intake should be maintained.
Effects On Ability To Drive And Use Machines
None documented.
Pregnancy And Lactation
Pregnancy: There are no adequate data on the use of ergocalciferol in pregnant women. Ossofortin should not be used in pregnancy unless the potential benefit outweighs the potential hazards to the foetus.
Lactation: Ergocalciferol is excreted in breast milk in limited amounts. Ossofortin should not be administered to breast-feeding mothers.
Undesirable Effects
Adverse events are generally associated with excessive intake of ergocalciferol leading to the development of hypercalcaemia. The symptoms of hypercalcaemia can include: anorexia, nausea, vomiting, diarrhoea, loss of weight, headache, polyuria, thirst, vertigo, constipation, fatigue, bone pain, muscle weakness, abdominal pain, mental disturbances, impaired renal function, kidney stones and cardiac arrhythmias.
Overdose
A single acute overdose is virtually non-toxic and requires supportive treatment with liberal fluids only. Chronic administration to patients in excess of their daily requirement can cause hypercalcaemia, hypercalciuria and hyperphosphataemia. Concomitant high intake of calcium and phosphate may lead to similar abnormalities.
Treatment of chronic overdose with resulting hypercalcaemia consists of immediate withdrawal of the vitamin, a low calcium diet, and generous fluid intake. Severe cases may require hydration with intravenous saline together with symptomatic and supportive treatment as indicated by the patient’s clinical condition. Plasma calcium and U&E’s should be monitored.
Other Information
Composition
Each film coated tablet contains
- Active Ingredient: Ergocalciferol 0.25 mg (10,000 IU).
- Excipients: Sesame oil, Colloidal silicon dioxide, Polyvinylpyrrolidone, Prosolv Easy Tab (microcrystalline cellulose,colloidal silicon dioxide, sodium starch glycolate,sodium starch fumarate). Crospovidone,opadry.
Pharmaceutical Form
Film coated tablets.
Interaction With Other Medicinal Products And Other Forms Of Interaction
Phosphate infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the dangers of metastatic calcification. Vitamin D requirements may be increased in patients taking anti-convulsants (e.g. Carbamazepine, phenobarbital, phenytoin, and primidone).
Absorption of calcium may be reduced by oral sodium sulphate or parenteral magnesium sulphate. Concurrent use of Vitamin D analogues and cardiac glycosides may result in cardiac arrhythmias due to hypercalcaemia. There is an increased risk of hypercalcaemia if vitamin D is administered with thiazide diuretics and calcium.
Storage
Store in a dry place, at a temperature not exceeding 30° C. Keep out of reach of children.
Pack
Carton box containing 1, 2 or 3 AV/AI blisters each of 10 tablets.
