ERGOCALCIFEROL

Route of Administration:

IM injection Posology Adults and Elderly Ergocalciferol Injection is typically administered as a single dose of 300,000 IU every 3-6 months. Paediatric population In children 1-12 years, a bolus dose 300,000IU ergocalciferol is generally given in 2 divided doses.

However, for all age groups dosage should be individualised by the clinician for each patient dependent upon clinical response and requirements. Serum and urinary calcium concentrations, phosphate and BUN should be monitored at regular intervals, initially weekly, in order to achieve optimum clinical response and to avoid hypercalcaemia.

Calcium and phosphorous supplements should be administered where necessary.

Adverse events are generally associated with excessive intake of ergocalciferol leading to the development of hypercalcaemia.

The following convention has been used for the classification of frequency:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) System Organ Class Adverse event Frequency Hypercalcaemia * Very common Hypercholesterolaemia† Not known Muscle weakness§ Not known Muscle pain§ Not known Mild acidosis† Not known Polydipsia† Not known Metabolism and nutrition disorders Anorexia† Not known Overt psychosis† RarePsychiatric disorders Somnolence§ Not known Nervous system disorders Headache§ Not known Endocrine disorders Hypoparathyroidism* pseudohypopathyroidism* Very common Conjunctivitis (calcific) Not knownEye disorders Photophobia Not known Cardiac disorders Cardiac arrhythmias Not known Rebal disorders Elevated serum creatinine levels* Very common Generalised vascular calcification† Not knownVascular disorders Hypertension† Not known Respiratory, thoracic and mediastinal disorders Rhinorrhoea† Not known Pancreatitis† Not known Nausea§ Not known Vomiting§ Not known Dry mouth§ Not known Constipation§ Not known Diarrhoea§ Not known Gastrointestinal disorders Abdominal pain§ Not known Skin and subcutaneous tissue disorders Pruritus† Not known Bone pain§ Not knownMusculoskeletal and connective tissue disorders Ectopic calcification† Not known Polyuria† Not known Nocturia† Not known Nephrocalcinosis† Not known Albuminuria† Not known Renal and urinary disorders Reversible azotemia† Not known Reproductive system and breast disorders Decreased libido† Not known System Organ Class Adverse event Frequency Hyperthermia† Not known Fatigue§ Not known Irritability† Not known General disorders and administration site conditions Weakness§ Not known Elevated AST † Not known Elevated ALT† Not known Elevated BUN† Not known Investigations Weight loss† Not known Surgical and medical procedures Metallic taste§ Not known *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.

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.

1. Hypercalcaemia, evidence of vitamin D toxicity, hypervitaminosis D, decreased renal function, metastatic calcification.