Calcium Chloride Drug Information

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.

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.

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.

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.

Drug Incompatibilities

Do not mix Calcium Chloride Injection with other drugs simultaneously.

• 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 Adverse reactions have included paraesthesia (upon rapid injection), calcium taste, sense of oppression, sense of “heat wave”, local burning sensation, injection site extravasation, injection site reactions, peripheral vasodilatation, and decreased blood pressure. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

Calcium Channel Blockers

Concomitant use of Calcium Chloride Injection and calcium channel blockers may reduce the response to calcium channel blockers. Avoid concomitant use.

Drugs That Increase the Risk of Hypercalcemia

See 17 for PATIENT COUNSELING INFORMATION. Revised: 05/2023

• 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. 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, regardless of whether these products would be received at different times or through separate intravenous lines.

Overdosage of Calcium Chloride Injection may lead to hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥12 mg/dL, and include shortening of QT interval, bradycardia, hypertension, anorexia, nausea, vomiting, bowel hypomotility and constipation, muscle weakness, bone pain, decreased concentration, depression, weakness, fatigue, confusion, hallucinations, disorientation, hypotonicity, seizures, and coma. Hypercalcemia effects on kidney include diminished ability to concentrate urine and diuresis.

In the event of overdosage, promptly discontinue Calcium Chloride Injection, the patient should be re-evaluated and appropriate countermeasures should be instituted, if necessary.