Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: hameln pharmaceuticals ltd, Gloucester, UK
Calcium is an essential body electrolyte. It is necessary for the functional integrity of nerve and muscle and is essential for the muscle contraction, cardiac function and coagulation of the blood.
Calcium homeostasis is mainly regulated by three endocrine factors: parathyroid hormone is secreted in response to a fall in plasma calcium concentration and acts by accelerating calcium transfer from bone and by increasing its intestinal absorption and its renal reabsorption; calcitonin lowers plasma calcium by decreasing bone resorption and by increasing renal excretion of the ion; vitamin D stimulates intestinal absorption of calcium and decreases its renal excretion.
Parenteral administration of calcium is indicated where the pharmacological action of a high calcium ion concentration is required, as for example, in acute hypocalcaemia, cardiac resuscitation and some cases of neonatal tetany.
Intravenous injections of calcium have been used in the treatment of the acute colic of lead poisoning, and as an adjunct in the treatment of acute fluoride poisoning. Also, for the prevention of hypocalcaemia in exchange transfusions.
The normal concentration of calcium in plasma is within the range of 2.25-2.75 mmol or 4.5-5.5 mEq per litre. Treatment should be aimed at restoring or maintaining this level.
During therapy, serum calcium levels should be monitored closely.
Acute hypocalcaemia: 10-20ml (2.2-4.4mmol)
Fluoride or lead poisoning: 0.3ml/kg (0.07mmol/kg)
Neonatal tetany: 0.3ml/kg (0.07mmol/kg)
Cardiac resuscitation: 7-15ml (1.54-3.3mmol). It should be noted that the absolute amount of calcium required for this indication is difficult to determine and may vary widely.
In hypocalcaemic tetany, an initial intravenous injection of 10ml of the 10% solution (2.25mmol) should be followed by a continuous infusion of about 40ml (9mmol) daily. Plasma calcium should be monitored.
Calcium Gluconate Injection is indicated for the treatment of neonatal tetany – it should not be routinely used in children less than 18 years of age.
Although there is no evidence that tolerance of Calcium Gluconate Injection is directly affected by advanced age, factors that may sometimes be associated with ageing, such as impaired renal function and poor diet, may indirectly affect tolerance and may require a reduction in dosage. Renal function declines with age and prior to prescribing this product to elderly patients it should be considered that Calcium Gluconate injection is contraindicated (See section 4.3) for repeated or prolonged administration in patients with impaired renal function.
The intravenous administration rate should not exceed 2 ml (0.45 mmol of calcium) per minute.
The patient should be in the lying position and should be closely observed during injection. Monitoring should include heart rate or ECG.
Calcium Gluconate Injection can be diluted with glucose 5% or sodium chloride 0.9%. Dilution into a solution containing bicarbonate, phosphate or sulfate should be avoided.
Symptoms of hypercalcaemia may include: anorexia, nausea, vomiting, constipation, abdominal pain, polyuria, polydipsia, dehydration, muscle weakness, bone pain, renal calcification, drowsiness, confusion, hypertension and, in severe cases, cardiac arrhythmia up to cardiac arrest, and coma.
If intravenous injection is too rapid, symptoms of hypercalcaemia may occur as well as a chalky taste, hot flushes and hypotension.
Treatment should be aimed at lowering the elevated plasma calcium concentration.
Initial management should include rehydration and, in severe hypercalcaemia, it may be necessary to administer sodium chloride by intravenous infusion to expand the extracellular fluid. Calcitonin may be given to lower the elevated serum calcium concentration. Furosemide may be administered to increase calcium excretion but thiazide diuretics should be avoided as they may increase renal absorption of calcium.
Haemodialysis or peritoneal dialysis may be considered where other measures have failed and where the patient remains acutely symptomatic. Serum electrolytes should be carefully monitored throughout treatment of overdose.
Shelf life: 36 months.
Store at less than 25°C.
Type I clear glass ampoule, 10ml. Packed in cardboard cartons to contain 10 ampoules x 10ml.
Use as directed by a physician.
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