Calcium Gluconate Injection

Active Ingredients: Calcium Gluconate

CalCare™ Calcium Gluconate Injection 10% is a sterile solution for intravenous administration. Each 1mL contains 100mg of calcium gluconate. This provides approximately 9.3mg (0.465mEq) of elemental calcium. Each 10mL ampoule therefore provides approximately 93mg (4.65mEq) of elemental calcium.

The medicine is intended for acute symptomatic hypocalcemia in adult and pediatric patients. The current U.S. prescribing information identifies this as the approved indication and notes that long-term safety has not been established.

After intravenous administration, calcium gluconate dissociates in plasma and raises ionized calcium. Ionized calcium supports nerve transmission, skeletal and cardiac muscle contraction, blood coagulation and other calcium-dependent functions.

Calcium gluconate is not equivalent to calcium chloride on a milligram-for-milligram basis. The two salts deliver different amounts of elemental calcium. Product selection and dosing must account for the actual elemental calcium supplied.

CalCare™ is manufactured for human use in GMP-compliant facilities. The 1g/10mL ampoule format supports hospital tenders, institutional procurement and distributor registration. Availability is subject to the approved dossier and local market requirements.

AdvaCare Pharma manufactures Calcium Gluconate Injection 10% (1g/10mL) for human use through GMP-compliant pharmaceutical production facilities and supplies pharmaceutical distributors, hospital suppliers, NGOs and institutional procurement partners across international markets.

The human pharmaceutical presentation is available as a 10% solution in a 1g/10mL ampoule. Packaging options include 10 ampoules per box and 50 ampoules per box, subject to manufacturing origin and country-specific regulatory requirements.

For pharmaceutical distributors, AdvaCare Pharma provides commercial and regulatory support throughout product registration, market entry and ongoing supply. Support may include product documentation, registration coordination, market-specific packaging and supply planning.

What is Calcium Gluconate used for?

Calcium Gluconate Injection is used to treat acute symptomatic hypocalcemia in adults and children. Intravenous treatment is appropriate when calcium must be corrected promptly under clinical supervision. The underlying cause of hypocalcemia must also be investigated and treated.

How is Calcium Gluconate Injection administered?

A qualified healthcare professional administers the medicine through a secure intravenous line. It may be given as a diluted slow bolus or continuous infusion, depending on the clinical situation and approved label. Dose, dilution, rate and duration are individualized according to age, symptoms, serum calcium, renal function and response.

How does Calcium Gluconate Injection work?

Calcium gluconate dissociates after intravenous administration and increases ionized calcium in the blood. Ionized calcium is the biologically active fraction needed for normal neuromuscular and cardiovascular function.

What monitoring is required?

Monitor the patient, vital signs, serum calcium and ECG as clinically appropriate. The DailyMed calcium gluconate label provides detailed administration, monitoring, incompatibility and safety information.

What is the difference between calcium gluconate and calcium chloride?

Both provide intravenous calcium, but calcium chloride contains more elemental calcium for an equivalent mass of salt. It is also more damaging if extravasation occurs. The products are not interchangeable milligram for milligram. Selection depends on the clinical situation, venous access and treatment protocol.

Who can use Calcium Gluconate?

Calcium Gluconate Injection may be used in adult and pediatric patients when intravenous calcium is clinically indicated. Additional precautions apply to certain patient populations.

For life-threatening arrhythmia associated with hypocalcemia, hyperkalemia, or hypermagnesemia in infants and children, the usual dose is 60-100mg/kg per dose, given by IV/IO every 10 minutes, as needed. The maximum rate is 100mg/min. The maximum dosage is 800mg/dose and 3g per episode.

For calcium channel blocker overdose, the usual dose is 60mg/kg per dose, given by IV over 10 minutes. The dose can be repeated every 20 minutes for up to 5 times, as needed.

For cardiac arrest associated with hyperkalemia, hypocalcemia, or hypermagnesemia, the usual dose is 1.5-3g given by IV over 2-5 minutes.

The dosage is based on medical condition, response to the treatment, age, and weight. Refer to a doctor or healthcare professional for guidelines on the exact dosage.

Note on dosage: For an intravenous solution containing 10% calcium gluconate, there is 100mg/mL, or elemental calcium 0.465mEq/mL.

What happens in an overdose?

Excessive administration can cause hypercalcemia. Possible effects include weakness, fatigue, confusion, reduced muscle tone, seizures, coma and cardiovascular or renal complications. Stop calcium administration and provide prompt clinical assessment and supportive care.

Other warnings

The safety of long-term intravenous calcium gluconate use has not been established. Exact dosing and administration instructions must follow the locally approved prescribing information and institutional protocol.

Rapid administration increases the risk of serious cardiovascular reactions. Extravasation can cause severe local injury. Monitor patients during administration and assess suspected serious reactions promptly.

For complete contraindications, warnings and adverse-reaction information, refer to the locally approved prescribing information.

Administer only through secure intravenous access. Extravasation can cause calcinosis cutis, ulceration, tissue necrosis or secondary infection. Stop administration at the affected site if extravasation or signs of calcinosis occur.

Rapid intravenous administration can cause vasodilation, hypotension, bradycardia, arrhythmias, syncope or cardiac arrest. Dilution, infusion rate and monitoring must follow the approved prescribing information. Monitor vital signs and ECG when clinically indicated.

Avoid administration with cardiac glycosides when possible. If concurrent use is clinically necessary, give calcium slowly in small amounts with close ECG monitoring.

Do not mix calcium gluconate with ceftriaxone or with solutions containing bicarbonate or phosphate. Precipitation may occur. For patients older than 28 days, sequential administration with ceftriaxone may be permitted only when the approved label allows it and the line is thoroughly flushed with a compatible fluid between infusions. Never administer the products simultaneously through the same Y-site.

For renal impairment, begin at the low end of the approved dose range and monitor serum calcium closely. Inspect the solution before use. Do not administer a discolored solution or one containing visible particles.

Use only under the supervision of a qualified healthcare professional. Follow the locally approved prescribing information for dilution, dosage, infusion rate, compatibility and monitoring.

Acute symptomatic hypocalcemia is a potentially serious condition caused by an insufficient concentration of ionized calcium and may require intravenous calcium replacement.

The prescribing information states that Calcium Gluconate Injection is indicated for the treatment of acute symptomatic hypocalcemia in adult and pediatric patients. It describes intravenous administration through a secure IV line, individualized dosing according to serum calcium levels and clinical response, and appropriate patient monitoring. The prescribing information also outlines important safety considerations, including the risks associated with rapid administration, extravasation, cardiac glycosides, renal impairment and concomitant administration with ceftriaxone in neonates.

The prescribing information supports the use of intravenous calcium gluconate for acute symptomatic hypocalcemia when administered with appropriate dosing, monitoring and precautions.

Society for Endocrinology Emergency Guidance: Emergency Management of Acute Hypocalcaemia in Adult Patients

Severe or symptomatic hypocalcemia is a medical emergency that can cause neuromuscular symptoms, tetany, seizures, ECG abnormalities and cardiac arrhythmias.

This clinical guidance recommends intravenous calcium gluconate for severe or symptomatic hypocalcemia. It describes the use of 10% calcium gluconate with ECG monitoring and emphasizes that treatment should be adjusted according to the patient's clinical response and serum calcium levels. The guidance also notes that the underlying cause of hypocalcemia should be identified and treated. Calcium chloride may be used as an alternative source of intravenous calcium, but it is more irritating to veins and generally requires greater caution during administration.

The guidance concludes that intravenous calcium gluconate is an established treatment for the emergency management of severe or symptomatic hypocalcemia, with appropriate biochemical and cardiovascular monitoring.

Calcium gluconate 10% is an intravenous calcium preparation used when rapid correction of clinically significant calcium deficiency is required.

The Summary of Product Characteristics describes the use of Calcium Gluconate 10% for acute symptomatic hypocalcemia and provides detailed information on intravenous administration, serum calcium monitoring, contraindications, drug interactions and adverse reactions. It also highlights precautions relating to extravasation, cardiac glycosides, renal impairment and ceftriaxone administration in neonates. The document further explains that calcium gluconate and calcium chloride contain different amounts of elemental calcium and should not be considered directly interchangeable.

The SmPC supports the controlled intravenous use of Calcium Gluconate 10% with careful attention to calcium levels, administration rate, compatibility and patient-specific risk factors.