Calcium Gluconate In Sodium Chloride

1) • Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. 1) • Individualize the dose within the recommended range in adults and pediatric patients depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia.

See Table 1 in the FPI for dosing recommendations in mg of calcium gluconate for neonates, pediatric and adult patients. 2) • Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours.

3) • Calcium Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. See FPI for all drug incompatibilities. 1 Important Administration Instructions See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection.

Table 1. 3 mEq per 100 mL • Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. Any unused portion should be discarded. • Inspect Calcium Gluconate in Sodium Chloride Injection visually prior to administration. The solution should appear clear and colorless.

Do not administer if there is particulate matter or discoloration. 3)]. 4)] . 2 Recommended Dosage Individualize the dose of Calcium Gluconate in Sodium Chloride Injection within the recommended range depending on the severity of symptoms of hypocalcemia, the serum calcium level, and the acuity of onset of hypocalcemia.

Table 2 provides dosing recommendations for Calcium Gluconate in Sodium Chloride Injection in mg of calcium gluconate for neonates, pediatric and adult patients. Table 2. 3 Serum Calcium Monitoring Measure serum calcium every 4 to 6 hours during intermittent infusions with Calcium Gluconate in Sodium Chloride Injection and measure serum calcium every 1 to 4 hours during continuous infusion.

4 Dosage in Renal Impairment For patients with renal impairment, initiate Calcium Gluconate in Sodium Chloride Injection at the lowest dose of the recommended dose ranges for all age groups and monitor serum calcium levels every 4 hours.

5 Drug Incompatibilities • Do not mix Calcium Gluconate in Sodium Chloride Injection with ceftriaxone. Concurrent use of intravenous ceftriaxone and Calcium Gluconate in Sodium Chloride Injection can lead to the formation of ceftriaxone-calcium precipitates.

5)] The following adverse reactions associated with the use of calcium gluconate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiovascular :

Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, cardiac arrest Administration site reactions : Local soft tissue inflammation, local necrosis, calcinosis cutis and calcification due to extravasation The most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation.

Other adverse events include vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, and cardiac arrest. gov/medwatch.

1) • End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates. Do not administer ceftriaxone simultaneously with Calcium Gluconate in Sodium Chloride Injection via a Y-site in any age group.

Cases of fatal outcomes in neonates have occurred. 2) • Tissue Necrosis and Calcinosis: Calcinosis cutis can occur with or without extravasation of Calcium Gluconate in Sodium Chloride Injection. Tissue necrosis, ulceration, and secondary infection are the most serious complications.

If extravasation occurs or clinical manifestations of calcinosis cutis are noted, immediately discontinue intravenous administration at that site and treat as needed. 3) • Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration: To avoid adverse reactions that may follow rapid intravenous administration, Calcium Gluconate in Sodium Chloride Injection should be infused slowly, with careful ECG monitoring for cardiac arrhythmias.

4) • Aluminum Toxicity: This product contains aluminum, up to 25 mcg per liter, that may be toxic. 1 Arrhythmias with Concomitant Cardiac Glycoside Use Cardiac arrhythmias may occur if calcium and cardiac glycosides are administered together.

Hypercalcemia increases the risk of digoxin toxicity. Administration of Calcium Gluconate in Sodium Chloride Injection should be avoided in patients receiving cardiac glycosides. 1)] . 2 End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates Concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates (28 days of age or younger) due to cases of fatal outcomes in neonates in which a crystalline material was observed in the lungs and kidneys at autopsy after ceftriaxone and calcium were administrated simultaneously through the same intravenous line.

Concomitant administration can lead to the formation of ceftriaxone-calcium precipitates that may act as emboli, resulting in vascular spasm or infarction [see Contraindications (4)]. In patients older than 28 days of age, ceftriaxone and Calcium Gluconate in Sodium Chloride Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.

2)] • Hypercalcemia (4) • Neonates (28 days of age or younger) receiving ceftriaxone (4)