Calcium Chloride

4)]. The maximum recommended infusion rate is 1 mL/minute (100 mg/minute). 4)]. • 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 Recommended Dosage and Administration The recommended dose range of Calcium Chloride Injection in: • Adults is from 200 mg to 1,000 mg. 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. 6)]: • Adults with renal impairment is 200 mg. 7 mg/kg of calcium chloride. 4 Drug Incompatibilities Do not mix Calcium Chloride Injection with other drugs simultaneously.

1)]: • In neonates (28 days of age or younger), concomitant use of Calcium Chloride Injection and ceftriaxone is contraindicated [see Contraindications (4)]. • 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.

• Administer Calcium Chloride Injection by slow intravenous infusion (not to exceed 1 mL/minute), in a central or deep vein. 1) • Do not use intramuscularly or subcutaneously. 1) • Do not administer unless solution is clear and seal is intact.

1) • Stop the administration if the patient complains of any administration-related discomfort, it may be resumed when symptoms disappear. 1) • The recommended adult dose is from 200 mg to 1,000 mg. 7 to 5 mg/kg of calcium chloride. 2) • Repeated injections may be required because of rapid calcium excretion.

5)] 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.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch.

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 [see Contraindications (4)].

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.

4)]. 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. 1)]. 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. 1)]. 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.

1)]. Calcium Chloride Injection is contraindicated in: • Patients with ventricular fibrillation. (4) • Patients with asystole and electromechanical dissociation. (4) • 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.

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