10% CALCIUM GLUCONATE Injection/Solution for

What is 10% CALCIUM GLUCONATE

10% CALCIUM GLUCONATE is a sterile injectable solution containing calcium gluconate, primarily used to treat conditions associated with hypocalcemia (low calcium levels in the blood). It is supplied in a 10ml plastic ampoule, with each 10ml containing 1g of calcium gluconate, equivalent to approximately 90mg of elemental calcium.

• Therapeutic Use: It is widely used in clinical settings to manage acute symptomatic hypocalcemia, such as in patients with parathyroid hormone deficiency, vitamin D disorders, or during massive blood transfusions that lead to citrate toxicity.
• Medical Emergencies: Calcium gluconate is essential in treating cardiac toxicity caused by hyperkalemia (elevated potassium levels) and magnesium sulfate overdose.
• Supportive Therapy: It is also indicated for calcium replenishment during resuscitation in intensive care units, surgical procedures, and in neonates with hypocalcemic seizures.

The injection is usually administered intravenously under the supervision of healthcare professionals. Calcium gluconate is preferred over calcium chloride in most cases because it is less irritating to veins and causes fewer local adverse effects.

How to use 10% CALCIUM GLUCONATE

10% CALCIUM GLUCONATE Injection must be administered by a healthcare professional in a hospital or clinical setting. The method of administration, dosing, and monitoring depends on the indication and the patient’s clinical condition.

• Intravenous (IV) Use Only: The solution should be given slowly by intravenous injection or infusion. Rapid administration may lead to serious cardiac effects.
• Dilution: Depending on the dose and clinical indication, calcium gluconate may be diluted in compatible IV fluids like 5% dextrose or normal saline before administration.
• Injection Rate: Administer slowly at a rate not exceeding 2ml per minute. For IV infusion, follow institutional guidelines.
• Monitoring: Monitor serum calcium levels, ECG, and vital signs during and after administration, especially in patients with cardiac or renal conditions.

Do not administer intramuscularly or subcutaneously, as this can cause tissue necrosis or severe irritation. Special caution should be taken in patients on digitalis therapy due to the risk of arrhythmias.

Mode of Action 10% CALCIUM GLUCONATE

Calcium gluconate acts as a calcium supplement, essential for many physiological processes in the human body. The pharmacological effects are directly related to calcium’s role in cellular functions.

• Restores Calcium Levels: It replenishes deficient calcium levels in extracellular fluid, helping restore normal neuromuscular and cardiovascular function.
• Stabilizes Cardiac Membranes: In hyperkalemia and hypermagnesemia, calcium gluconate stabilizes cardiac membranes, reducing the risk of arrhythmias without altering potassium or magnesium concentrations directly.
• Enzyme Activation: Calcium is a co-factor for numerous enzymatic reactions, including those involved in muscle contraction, blood coagulation, and hormone secretion.
• Neurotransmission: Calcium facilitates synaptic transmission and helps regulate muscle contractions by acting at the neuromuscular junction.

Upon IV administration, calcium gluconate dissociates into calcium and gluconate ions. The free calcium ions are then available for physiological use in bones, blood, and soft tissues. Its onset of action is typically within minutes, especially in cardiac and neuromuscular settings.

10% CALCIUM GLUCONATE Interactions 10% CALCIUM GLUCONATE

Calcium gluconate can interact with various medications, altering their efficacy or increasing the risk of side effects. It is important to assess drug interactions before initiating therapy.

• Digitalis (Digoxin): Concurrent use may lead to serious cardiac arrhythmias. Avoid co-administration or ensure strict cardiac monitoring if both are necessary.
• Calcium Channel Blockers (e.g., Verapamil, Nifedipine): Antagonistic interaction; calcium gluconate may diminish the effects of these drugs.
• Phosphate-containing IV fluids: Risk of calcium-phosphate precipitation when administered simultaneously; avoid mixing in the same line.
• Magnesium Sulfate: Co-administration may counteract the effects of magnesium, especially in cases of magnesium toxicity.
• Tetracyclines and Quinolones: Calcium may form insoluble complexes with these antibiotics, reducing their absorption if administered orally. Not a major concern with IV calcium gluconate but still notable in patients on both routes.

Always inform your healthcare provider about all current medications to avoid interactions that may compromise safety or therapeutic efficacy.

Dosage of 10% CALCIUM GLUCONATE

Dosage must be individualized based on the patient’s calcium levels, clinical condition, and response to therapy. Below are general dosage guidelines:

• Adults: 10ml of 10% calcium gluconate (equivalent to 1g of calcium gluconate or ~90mg elemental calcium) administered intravenously over 5–10 minutes.
• Children: 100–200mg/kg/dose of calcium gluconate, given IV slowly, not to exceed 3g per dose.
• Neonates: 100mg/kg per dose IV slowly under ECG monitoring.

In cases of severe hypocalcemia or acute hyperkalemia, repeat doses may be necessary based on calcium levels and clinical response. Calcium gluconate may also be administered via continuous IV infusion for persistent hypocalcemia.

• ECG Monitoring: Essential when high doses or repeated administrations are required, especially in patients with renal impairment or those receiving cardiac medications.
• Avoid Overcorrection: Frequent monitoring is essential to avoid hypercalcemia, which can cause serious complications including arrhythmias and renal damage.

Always consult a healthcare provider for precise dosing and administration parameters tailored to the individual.

Possible side effects of 10% CALCIUM GLUCONATE

While generally well-tolerated under medical supervision, 10% Calcium Gluconate may cause side effects, especially when administered improperly or in sensitive individuals.

• Common Side Effects:
  • Injection site pain or irritation
  • Flushing or a sensation of warmth
  • Nausea or metallic taste
• Serious Adverse Effects:
  • Bradycardia (slow heart rate)
  • Arrhythmias or ECG changes
  • Hypercalcemia (confusion, vomiting, polyuria)
  • Local tissue necrosis with extravasation
• Hypersensitivity Reactions: Rarely, patients may experience allergic reactions such as rash, pruritus, or anaphylaxis.

To minimize adverse reactions, administer the injection slowly and under ECG monitoring, especially in cardiac or renal-compromised patients.

10% CALCIUM GLUCONATE Contraindications 10% CALCIUM GLUCONATE

10% Calcium Gluconate is contraindicated in specific patient populations and clinical conditions due to the risk of adverse outcomes.

• Hypercalcemia: Patients with elevated serum calcium should not receive calcium gluconate as it can exacerbate toxicity.
• Ventricular Fibrillation: IV calcium is contraindicated in patients with this arrhythmia, as it may worsen the condition.
• Digitalis Toxicity: Concurrent use with digoxin can precipitate life-threatening arrhythmias.
• Severe Renal Impairment: Use with caution; impaired calcium clearance may cause hypercalcemia and soft tissue calcification.
• Hypersensitivity: Known allergy to calcium gluconate or any component of the injection is a strict contraindication.

Always perform a thorough medical evaluation before administration to rule out these contraindications and ensure safe use.

Storage of 10% CALCIUM GLUCONATE

Proper storage of 10% Calcium Gluconate is critical to maintain its potency, sterility, and safety.

• Temperature: Store at 15°C to 25°C (59°F to 77°F). Avoid extreme temperatures or freezing, as this may cause precipitation or degradation of the solution.
• Light Sensitivity: Protect from direct light. Keep ampoules in their original packaging until use to prevent photodegradation.
• Inspect Before Use: Do not use if the solution appears cloudy, discolored, or contains particulates. Discard damaged or cracked ampoules.
• Single-use Only: Once opened, any unused portion should be discarded. Do not reuse partially used ampoules.
• Keep Out of Reach: Store out of reach of children and unauthorized personnel in healthcare settings.

Ensure compliance with hospital pharmacy storage guidelines and expiry checks to maintain the product’s integrity and effectiveness.