calcium chloride injection, USP - ANYSYR Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION.

CALCIUM CHLORIDE injection, for intravenous use only
Initial U.S. Approval: 1938

INDICATIONS AND USAGE

Calcium Chloride Injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute symptomatic hypocalcemia. (1)

Limitations of Use:

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

DOSAGE AND ADMINISTRATION

•
Administer Calcium Chloride Injection by slow intravenous infusion (not to exceed 1 mL/minute), in a central or deep vein. (2.1)
•
Do not use intramuscularly or subcutaneously. (2.1)
•
Do not administer unless solution is clear and seal is intact. (2.1)
•
Stop the administration if the patient complains of any administration-related discomfort, it may be resumed when symptoms disappear. (2.1)
•
The recommended adult dose is from 200 mg to 1,000 mg. (2.2)
•
The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium chloride. (2.2)
•
Repeated injections may be required because of rapid calcium excretion. (2.2)
•
See the full prescribing information for the recommended starting dose in patients with renal impairment. (2.3)
•
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. (2.4)

DOSAGE FORMS AND STRENGTHS

Calcium Chloride Injection, USP (single-dose) is supplied as: (3)

•
10% (1,000 mg/10 mL) (100 mg/mL) in an Ansyr Plastic Syringe
•
10% (1,000 mg/10 mL) (100 mg/mL) in a LifeShield Abboject Glass Syringe

The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. (3)

CONTRAINDICATIONS

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. (4, 5.1)

WARNINGS AND PRECAUTIONS

•
End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Calcium Chloride Injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment. In patients older than 28 days of age, do not mix or administer simultaneously with ceftriaxone intravenous solutions, even via different infusion lines or at different infusion sites as it can lead to precipitation of ceftriaxone-calcium. (5.1)
•
Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration: Too rapid an injection exceeding 1 mL/minute may lead to hypotension and syncope. (2.1, 5.2)
•
Arrhythmias with Concomitant Digoxin Use: Avoid use of Calcium Chloride Injection in patients receiving digoxin. Closely monitor ECG and calcium levels if concomitant therapy is necessary. (5.3, 7.1)
•
Tissue Necrosis and Calcinosis: Administer Calcium Chloride Injection slowly through a small needle into a large vein to minimize the risk of tissue necrosis, ulceration and calcinosis. Avoid extravasation or accidental injection into perivascular tissues. Immediately discontinue administration should perivascular infiltration occur. (2.1, 5.4)
•
Aluminum Toxicity: Risk of toxicity with prolonged administration if kidney function is impaired. Premature neonates are particularly at risk. When prescribing Calcium Chloride Injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day. (5.5)

ADVERSE REACTIONS

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. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Digoxin: Avoid concomitant use with Calcium Chloride Injection. If concomitant use is unavoidable, monitor ECG closely during administration of Calcium Chloride Injection. (5.3, 7.1)
•
Calcium Channel Blockers: Avoid concomitant use with Calcium Chloride Injection. If concomitant use is unavoidable, monitor blood pressure closely during administration of Calcium Chloride Injection. (7.2)
•
Drugs That Increase the Risk of Hypercalcemia: Increase the frequency of calcium concentration monitoring in patients taking Calcium Chloride Injection concomitantly with other drugs that increase the risk of hypercalcemia. (7.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use 10% CALCIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for 10% CALCIUM CHLORIDE INJECTION.

CALCIUM CHLORIDE injection, for intravenous use only
Initial U.S. Approval: 1938

INDICATIONS AND USAGE

Calcium Chloride Injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute symptomatic hypocalcemia. (1)

Limitations of Use:

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

DOSAGE AND ADMINISTRATION

•
Administer Calcium Chloride Injection by slow intravenous infusion (not to exceed 1 mL/minute), in a central or deep vein. (2.1)
•
Do not use intramuscularly or subcutaneously. (2.1)
•
Do not administer unless solution is clear and seal is intact. (2.1)
•
Stop the administration if the patient complains of any administration-related discomfort, it may be resumed when symptoms disappear. (2.1)
•
The recommended adult dose is from 200 mg to 1,000 mg. (2.2)
•
The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium chloride. (2.2)
•
Repeated injections may be required because of rapid calcium excretion. (2.2)
•
See the full prescribing information for the recommended starting dose in patients with renal impairment. (2.3)
•
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. (2.4)

DOSAGE FORMS AND STRENGTHS

Calcium Chloride Injection, USP (single-dose) is supplied as: (3)

•
10% (1,000 mg/10 mL) (100 mg/mL) in an Ansyr Plastic Syringe
•
10% (1,000 mg/10 mL) (100 mg/mL) in a LifeShield Abboject Glass Syringe

The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. (3)

CONTRAINDICATIONS

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. (4, 5.1)

WARNINGS AND PRECAUTIONS

•
End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Calcium Chloride Injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment. In patients older than 28 days of age, do not mix or administer simultaneously with ceftriaxone intravenous solutions, even via different infusion lines or at different infusion sites as it can lead to precipitation of ceftriaxone-calcium. (5.1)
•
Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration: Too rapid an injection exceeding 1 mL/minute may lead to hypotension and syncope. (2.1, 5.2)
•
Arrhythmias with Concomitant Digoxin Use: Avoid use of Calcium Chloride Injection in patients receiving digoxin. Closely monitor ECG and calcium levels if concomitant therapy is necessary. (5.3, 7.1)
•
Tissue Necrosis and Calcinosis: Administer Calcium Chloride Injection slowly through a small needle into a large vein to minimize the risk of tissue necrosis, ulceration and calcinosis. Avoid extravasation or accidental injection into perivascular tissues. Immediately discontinue administration should perivascular infiltration occur. (2.1, 5.4)
•
Aluminum Toxicity: Risk of toxicity with prolonged administration if kidney function is impaired. Premature neonates are particularly at risk. When prescribing Calcium Chloride Injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day. (5.5)

ADVERSE REACTIONS

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. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Digoxin: Avoid concomitant use with Calcium Chloride Injection. If concomitant use is unavoidable, monitor ECG closely during administration of Calcium Chloride Injection. (5.3, 7.1)
•
Calcium Channel Blockers: Avoid concomitant use with Calcium Chloride Injection. If concomitant use is unavoidable, monitor blood pressure closely during administration of Calcium Chloride Injection. (7.2)
•
Drugs That Increase the Risk of Hypercalcemia: Increase the frequency of calcium concentration monitoring in patients taking Calcium Chloride Injection concomitantly with other drugs that increase the risk of hypercalcemia. (7.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2023
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