Calcium Gluconate

465 mEq) of elemental calcium. 1 ) Administer intravenously (bolus or continuous infusion) via a secure intravenous line. 1 ) See Full Prescribing Information (FPI) for dilution instructions, administration rates and appropriate monitoring.

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. 5 ) Supplied in a single-dose vial or pharmacy bulk package (PBP). For PBP, dispense single-doses to many patients in a pharmacy admixture program; use within 4 hours of puncture.

e. 465 mEq) of elemental calcium. 5) ]. Inspect calcium gluconate injection visually prior to administration. The solution should appear clear and colorless to slightly yellow. Do not administer if there is particulate matter or discoloration.

Use the diluted solution immediately after preparation. 3) ] . Administer calcium gluconate injection by bolus administration or continuous infusion. 2) ] of calcium gluconate injection in 5% dextrose or normal saline to a concentration of 10 mg/mL to 50 mg/mL prior to administration.

Administer the dose slowly and DO NOT exceed an infusion rate of 200 mg/minute in adults or 100 mg/minute in pediatric patients, including neonates. 4) ] . 8 mg/mL to 10 mg/mL prior to administration. 4) ] . 6) ]. 2 Recommended Dosage Individualize the dose of calcium gluconate 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 1 provides dosing recommendations for calcium gluconate injection in mg of calcium gluconate for neonates, pediatric and adult patients. 5 mg/kg/hour For bolus administration, DO NOT exceed an infusion rate of: 200 mg/minute in adult patients 100 mg/minute in pediatric patients For continuous infusions, adjust rate as needed based on serum calcium levels.

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.

5 WARNINGS AND PRECAUTIONS Arrhythmias with Concomitant Cardiac Glycoside Use: If concomitant therapy is necessary, calcium gluconate injection should be given slowly in small amounts and close ECG monitoring is recommended. 1) End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates: Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates.

Cases of fatal outcomes in neonates have occurred. 2) Tissue Necrosis and Calcinosis: Calcinosis cutis can occur with or without extravasation of calcium gluconate 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 injection should be diluted with 5% dextrose or normal saline and infused slowly, with careful ECG monitoring for cardiac arrhythmias.

4) Aluminum Toxicity: This product contains aluminum, up to 400 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 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 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.

4 CONTRAINDICATIONS Calcium gluconate injection is contraindicated in: Hypercalcemia. 2) ]. Hypercalcemia. ( 4 ) Neonates (28 days of age or younger) receiving ceftriaxone. ( 4 )