ERGOCALCIFEROL Solution for injection Ref.[8405] Active ingredients: Vitamin D2

Adequate dietary calcium is necessary for clinical response to Ergocalciferol therapy.

Caution should be used when the injectable forms are used in patients with vitamin D resistant rickets as the range between the toxic and therapeutic dosage is narrow.

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.

Ergocalciferol is not recommended for use in hypoparathyroidism. In the event of hypoparathyroidism when Ergocalciferol is used, calcium, parathyroid hormone or dihydrotachysterol may be required.

Dosage should be individualised. Frequent serum and urinary calcium, phosphate and urea nitrogen determinations should be carried out. Adequate fluid intake should be maintained.

Should hyperglycaemia develop, Ergocalciferol should be discontinued immediately.

Because of the effect on serum calcium, Ergocalciferol should only be administered to patients with renal stones when potential benefits outweigh possible hazards.

Ergocalciferol and:

• Magnesium-containing antacids: hypermagnesaemia may develop in patients on chronic renal dialysis.
• Digitalis glycosides: hypercalcaemia in patients on digitalis may precipitate cardiac arrhythmias.
• Verapamil atrial fibrillation has recurred when supplemental calcium and Ergocalciferol have induced hypercalcaemia.
• Anti-convulsants: vitamin D requirements may be increased in patients taking anti-convulsants (e.g. carbamazepine, phenobarbital, phenytoin and primidone).
• Thiazide diuretics: hypoparathyroid patients on Ergocalciferol may develop hypercalcaemia due to increased Ergocalciferol (although Ergocalciferol is not recommended for use in hypoparathyroidism).

Pregnancy

There are no adequate data on the use of Ergocalciferol in pregnant women. Ergocalciferol Injection should not be used in pregnancy unless the potential benefit outweighs the potential hazards to the foetus.

Animal studies have shown foetal abnormalities associated with hypervitaminosis D. Calcifediol and calcitriol are teratogenic in animals when given in doses several times the human dose. The offspring of a woman administered 17-144 times the recommended dose of calcitriol during pregnancy manifested mild hypercalcaemia in the first 2 days of life, which returned to normal at day 3.

Lactation

Ergocalciferol is excreted in breast milk in limited amounts. In a mother given large doses of Ergocalciferol, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcaemia in the child. Monitoring of the infants serum calcium is required in such cases. Ergocalciferol should not be administered to breast-feeding mothers.

Ergocalciferol may cause drowsiness and, if affected, patients should not drive or operate machinery.

Adverse events are generally associated with excessive intake of ergocalciferol leading to the development of hypercalcaemia. The symptoms of hypercalcaemia can include:

Early: weakness; headache; somnolence; nausea; vomiting; dry mouth; constipation; diarrhoea; abdominal pain; fatigue; muscle weakness or pain; bone pain; metallic taste.

Late: polyuria; polydipsia; anorexia; irritability; weight loss; nocturia; mild acidosis; reversible azotaemia; generalised vascular calcification; nephrocalcinosis; conjunctivitis (calcific); pancreatitis; photophobia; rhinorrhoea; pruritis; hyperthermia; decreased libido; elevated BUN; albuminuria; hypercholesterolaemia; elevated AST and ALT; ectopic calcification; hypertension; cardiac arrhythmias; overt psychosis (rare).

In clinical studies on hypoparathyroidism and pseudohypopathyroidism, hypercalcaemia was noted on at least one occasion in about 1 in 3 patients and hypercalciuria in about 1 in 7. Elevated serum creatinine levels were observed in about 1 in 6 patients (approximately one half of whom had normal levels at baseline).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme on the MHRA website (www.mhra.gov.uk/yellowcard).

None stated.