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. C alcium Chloride Injection is a form of calcium indicated for the treatment of adult and pediatric 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.
Contraindications
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 [see Warnings and Precautions ( 5.1 )] . 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. ( 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 )
Two medicines in one question?
Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.
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 )
5.1End-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. 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 [see Dosage and Administration ( 2.4 )] .
5.2Hypotension, 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 [see Dosage and Administration ( 2.1 )] .
5.3Arrhythmias 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 [see Drug Interactions ( 7.1 )] .
5.4Tissue 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 [see Dosage and Administration ( 2.1 )] . Avoid extravasation or accidental injection into perivascular tissues. Should perivascular infiltration occur, immediately discontinue intravenous administration at that site and treat as needed.
5.5Aluminum Toxicity Calcium Chloride
Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature (preterm) neonates and preterm infants, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day can accumulate aluminum at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower amounts of aluminum. Exposure to aluminum from Calcium Chloride Injection at the recommended dose is not more than 10 mcg [see Dosage and Administration ( 2.2 ) and Description ( 11 )] . 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.
5.3 Arrhythmias with Concomitant Digoxin Use Arrhythmia
Our copy of this section ends here. The full text is in the official label at the FDA. Open Drugs@FDA
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 )
7.1Digoxin 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 [see Warnings and Precautions ( 5.3 )] .
7.2Calcium 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.
7.3Drugs 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).
Pregnancy and breastfeeding
Pregnancy: Animal reproduction studies have not been conducted with calcium chloride. It also is not known whether calcium chloride can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Calcium chloride should be given to a pregnant woman only if clearly needed.
Adverse reactions
The following serious adverse reactions are also described elsewhere in the labeling:
End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions ( 5.1 )]
Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration [see Warnings and Precautions ( 5.2 )]
Arrhythmias with Concomitant Digoxin Use [see Warnings and Precautions ( 5.3 )]
Tissue Necrosis and Calcinosis [see Warnings and Precautions ( 5.4 )]
Aluminum toxicity [see Warnings and Precautions ( 5.5 )] 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 Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Composition
Active ingredients
CALCIUM CHLORIDE 100MG/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
