CALCIUM GLUCONATE INJECTION 10% 10ML

CALCIUM GLUCONATE INJECTION 10% 10ML

  • Documents: GMP,COPP,CTD

CALCIUM GLUCONATE INJECTION 10% 10ML

Indications:

Parenteral administration of calcium is indicated where the pharmacological action of a high calcium ion concentration is required, as for example, in acute hypocalcaemia, and some cases of neonatal tetany.

Intravenous injections of calcium have been used in the treatment of the acute colic of lead poisoning.

Calcium Gluconate Injection for injection is used in the treatment of acute fluoride poisoning.

Also, for the prevention of hypocalcaemia in exchange transfusions.

Dosage and Administration:

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

Fluoride or lead poisoning: 0.3ml/kg (0.07mmol/kg)

Neonatal tetany: 0.3ml/kg (0.07mmol/kg)

Cardiac resuscitation: 7-15ml.

In hypocalcaemic tetany, an initial intravenous injection of 10ml of the 10% solution should be followed by a continuous infusion of about 40ml daily. Plasma calcium should be monitored.

Paediatric population:

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.

Elderly:

Renal function declines with age and prior to prescribing this product to elderly patients it should be considered that Calcium Gluconate injection is contraindicated for repeated or prolonged administration in patients with impaired renal function.

Precautions for use:

Solutions containing calcium should be administered slowly to minimise peripheral vasodilation and cardiac depression.

Intravenous injections should be accompanied by heart rate or ECG control because bradycardia with vasodilatation or arrhythmia can occur when calcium is administered too quickly.

Plasma levels and urinary excretion of calcium should be monitored when high-dose parenteral calcium is administered.

Calcium salts are irritant. The infusion site must be monitored regularly to ensure extravasation injury has not occurred.

Patients receiving calcium salts should be monitored carefully to ensure maintenance of correct calcium balance without tissue deposition.

High Vitamin D intake should be avoided.

Contra-indications:

Hypersensitivity to the active substance(s) or to any of the excipients.

This product is contraindicated in severe renal failure, hypercalcaemia (e.g. in hyperparathyroidism, hypervitaminosis D, neoplastic disease with decalcification of bone), severe hypercalciuria, and in patients receiving cardiac glycosides.

Calcium Gluconate Injection for injection must not be co-administered with ceftriaxone in:

• premature newborns up to a corrected age of 41 weeks (weeks of gestation and weeks of life),

• full-term newborns (up to 28 days of age)

because of the risk of precipitation of ceftriaxone-calcium

Drug interactions:

Cardiac glycosides

Thiazide diuretics

Epinephrine

Magnesium

Calcium antagonists

Ceftriaxone

Physical incompatibilities

Storage instructions:

Do not store above 25°C. Keep vials in the outer carton in order to protect from light.