Calcium Gluconate Injection | Calcium Supplement & Emergency

Product Description

1. Composition

Each 10 mL ampoule contains 950 mg calcium gluconate, stabilised with 50 mg calcium saccharate.

2. Pharmacological Classification

Electrolyte replacement agent.

3. Pharmacological Action

Calcium is an essential electrolyte in the human body. It is required to maintain the functional integrity of nerve and muscle tissue, and plays a critical role in muscle contraction, cardiac function and blood coagulation.

4. Indications

Parenteral calcium administration is indicated when the pharmacological effects of elevated calcium ion concentrations are required. Clinical applications include:

• Acute hypocalcaemia
• Cardiac resuscitation
• Selected cases of neonatal tetany
• Acute colic caused by lead poisoning
• Adjunctive treatment of acute fluoride poisoning
• Prevention of hypocalcaemia during exchange transfusions

5. Contraindications

• Repeated or prolonged use (including intravenous infusion) in children under 18 years of age and in patients with impaired renal function, due to the risk of aluminium exposure
• Severe renal failure
• Hypercalcaemia (e.g. hyperparathyroidism, hypervitaminosis D, neoplastic diseases with bone decalcification)
• Severe hypercalciuria
• Concomitant treatment with cardiac glycosides

Ceftriaxone co-administration contraindication

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

• Premature newborns up to a corrected age of 41 weeks (gestational weeks + postnatal weeks)
• Full-term newborns (up to 28 days of age)

due to the risk of ceftriaxone-calcium precipitate formation.

6. Dosage and Directions for Use

The normal plasma calcium concentration ranges from 2.25 to 2.75 mmol/L (4.5 to 5.5 mEq/L). Treatment aims to restore and maintain calcium levels within this range, and serum calcium must be closely monitored throughout therapy.

Dosage by indication

• Acute hypocalcaemia: 10–20 mL (2.2–4.4 mmol)
• Fluoride or lead poisoning: 0.3 mL/kg (0.07 mmol/kg)
• Neonatal tetany: 0.3 mL/kg (0.07 mmol/kg)
• Cardiac resuscitation: 7–15 mL (1.54–3.3 mmol). Note that the exact calcium requirement for this indication is difficult to determine and may vary widely between patients.

For hypocalcaemic tetany: an initial intravenous injection of 10 mL of the 10% solution (2.25 mmol) should be followed by continuous infusion of approximately 40 mL (9 mmol) daily. Plasma calcium levels must be monitored.

Administration instructions

• Intravenous injections must be administered very slowly (10 mL over 3 minutes).
• This product may be diluted with 5% glucose injection or 0.9% sodium chloride injection.

Dilution with solutions containing bicarbonate, phosphate or sulphate must be avoided.

Elderly patients

Although there is no direct evidence that advanced age alters tolerance to calcium gluconate, age-related factors such as impaired renal function and inadequate dietary intake may indirectly reduce tolerance and require dosage adjustment. Renal function declines with age; before prescribing to elderly patients, prescribers should note that repeated or prolonged administration is contraindicated in patients with impaired renal function.

Elderly patients

Although there is no direct evidence that advanced age alters tolerance to calcium gluconate, age-related factors such as impaired renal function and inadequate dietary intake may indirectly reduce tolerance and require dosage adjustment. Renal function declines with age; before prescribing to elderly patients, prescribers should note that repeated or prolonged administration is contraindicated in patients with impaired renal function.

7. Side Effects and Special Precautions

• Plasma calcium levels and urinary calcium excretion must be monitored during parenteral calcium therapy, particularly in children, patients with chronic renal failure, and patients with evidence of urinary tract calculus formation.

If plasma calcium exceeds 2.75 mmol/L, or 24-hour urinary calcium excretion exceeds 5 mg/kg, treatment must be discontinued immediately, as cardiac arrhythmias may occur at these levels.

• Use calcium salts with caution in patients with impaired renal function, nephrocalcinosis or cardiac disease.
• Calcium salts are irritant. The infusion site must be inspected regularly to detect extravasation injury.

Labelling warning: Each ampoule must be inspected for solution clarity prior to use. Use only if the solution is clear.

8. Overdosage and Treatment

Excessive administration of calcium salts causes hypercalcaemia. Symptoms include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, polydipsia, polyuria, mental disturbances, bone pain, nephrocalcinosis and renal calculi. Severe hypercalcaemia may lead to cardiac arrhythmias and coma.

Management of severe hypercalcaemia

1. Intravenous sodium chloride infusion to expand extracellular fluid volume.
2. Furosemide may be administered concomitantly or sequentially to increase calcium excretion.
3. If the above measures are ineffective, additional treatments include calcitonin, bisphosphonates, disodium edetate and phosphates.
4. Haemodialysis may be considered as a last resort.

Serum electrolytes must be monitored closely throughout overdose management.

9. Storage Instructions

Store at controlled room temperature (25°C / 77°F) and protect from light. Keep this medicine out of the reach of children.

10. Pack Information

Available in packs containing 10 ampoules of 10 mL per box.