Calcium chloride

What it is used for

Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia.

Limitations of Use The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established.

Side effects, and when to stop

The following serious adverse reactions are also described elsewhere in the labeling:

• End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates
• Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration
• Arrhythmias with Concomitant Digoxin Use
• Tissue Necrosis and Calcinosis
• Aluminum toxicity

The following adverse reactions have been identified in literature and postmarketing reports of calcium chloride. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

• Nervous system disorders: Paraesthesia (upon rapid injection), calcium taste
• General disorders and administration site conditions: Sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions
• Cardiovascular disorders: Peripheral vasodilatation, decreased blood pressure

Who should not take it

Calcium Chloride Injection is contraindicated in:

• Patients with ventricular fibrillation
• Patients with asystole and electromechanical dissociation

Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines.

2.1 Important Administration Instructions

Administer Calcium Chloride Injection by slow intravenous infusion in a central or deep vein in adults and pediatric patients (with or without renal impairment); do not administer by bolus. The maximum recommended infusion rate is 1 mL/minute (100 mg/minute).

Additional important administration instructions regarding Calcium Chloride Injection are as follows:

• Do not use intramuscularly or subcutaneously to avoid tissue necrosis calcinosis cutis.
• Visually inspect for particulate matter and discoloration prior to administration (the solution is clear, and the seal is intact). Do not administer if the solution is unclear or the seal is not intact.
• Stop the administration if the patient complains of any administration-related discomfort; administration may be resumed when symptoms disappear.
• Discard the unused portion.
• If time permits, allow the solution to warm to body temperature.

2.2 Recommended Dosage and Administration

The recommended dose range of Calcium Chloride Injection in:

• Adults is from 200 mg to 1,000 mg.
• Pediatric patients is from 2.7 to 5 mg/kg of calcium chloride.

Dosing of this Calcium Chloride Injection product is not possible in patients who require doses less than 200 mg because the recommended dose cannot be achieved with the supplied syringe. For patients who require doses less than 200 mg, use another calcium chloride injection product that allows dosing of less than 200 mg.

Individualize the dose for a patient within these dose ranges depending on serum ionized calcium level, severity of hypocalcemia symptoms, and the acuity of hypocalcemia onset.

Repeated injections may be required because of rapid excretion of calcium.

2.3 Recommended Starting Dose in Patients with Renal Impairment

The recommended starting dose of Calcium Chloride Injection in:

• Adults with renal impairment is 200 mg.
• Pediatric patients is 2.7 mg/kg of calcium chloride.

2.4 Drug Incompatibilities

Do not mix Calcium Chloride Injection with other drugs simultaneously. Do not mix Calcium Chloride Injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates:

• In neonates (28 days of age or younger), concomitant use of Calcium Chloride Injection and ceftriaxone is contraindicated.
• In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.

5.1 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates

The use of Calcium Chloride Injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines. Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have occurred when ceftriaxone and calcium were administered either simultaneously or non-simultaneously and through different intravenous lines. In-vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.

In patients older than 28 days of age, Calcium Chloride Injection and ceftriaxone intravenous solutions may be administered sequentially one after another if infusion lines at different sites are used, infusion lines are replaced, or infusion lines are thoroughly flushed between infusions with physiological salt solution to avoid precipitation. Do not mix or administer Calcium Chloride Injection simultaneously with ceftriaxone, even if using different infusion lines or different infusion sites as it can lead to precipitation of ceftriaxone-calcium.

5.2 Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration

Rapid injection of Calcium Chloride Injection may cause vasodilation, decreased blood pressure, bradycardia, arrhythmias, syncope, and cardiac arrest. It is particularly important to prevent a high concentration of calcium from reaching the heart because of the risk of syncope. Too rapid an injection exceeding 1 mL/minute may lead to hypotension and cardiac syncope.

5.3 Arrhythmias with Concomitant Digoxin Use

Arrhythmias may occur if Calcium Chloride Injection and digoxin are administered together. Hypercalcemia resulting from an overdose of Calcium Chloride Injection increases the risk of digoxin toxicity. Avoid the use of Calcium Chloride Injection in patients receiving digoxin. If concomitant therapy is necessary, closely monitor ECG and calcium levels.

5.4 Tissue Necrosis and Calcinosis

Administration of Calcium Chloride Injection in patients with local trauma may result in calcinosis cutis due to transient increase in local calcium concentration. Calcinosis cutis can occur with or without extravasation of Calcium Chloride Injection, is characterized by abnormal dermal deposits of calcium salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration. Tissue necrosis, ulceration, and secondary infection are the most serious complications.

To minimize the risk of tissue necrosis, ulceration and calcinosis, administer Calcium Chloride Injection slowly through a small needle into a large vein. Avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, immediately discontinue intravenous administration at that site and treat as needed.

7.1 Digoxin

Avoid the concomitant use of Calcium Chloride Injection with digoxin. If concomitant use is unavoidable, monitor ECG closely during administration of Calcium Chloride Injection.

Synergistic arrhythmias may occur with concomitant use. The use of Calcium Chloride Injection may result in hypercalcemia which increases the risk of digoxin toxicity.

7.2 Calcium Channel Blockers

Concomitant use of Calcium Chloride Injection and calcium channel blockers may reduce the response to calcium channel blockers. Avoid concomitant use. If concomitant use is unavoidable, monitor blood pressure closely during administration of Calcium Chloride Injection.

7.3 Drugs That Increase the Risk of Hypercalcemia

Increase frequency of monitoring of calcium concentrations in patients taking concomitant Calcium Chloride Injection and other drugs that increase the risk of hypercalcemia (e.g., calcipotriene, estrogen, lithium, parathyroid hormone, teriparatide, thiazide diuretics, Vitamin A, and Vitamin D).