Calcium Chloride Dihydrate

5 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) 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 [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)] . 5.2 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 [see Dosage and Administration (2.1)]. 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 [see Drug Interactions (7.1)] . 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 [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. 5.5 Aluminum 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.