Calcium Gluconate

• Administer intravenously (bolus or continuous infusion) via a secure intravenous line (2.1) • See Full Prescribing Information (FPI) for administration rates, and appropriate monitoring (2.1) • Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. Any unused portion should be discarded (2.1) • 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. (2.2) • Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. (2.3) • Calcium Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. See FPI for all drug incompatibilities. (2.5) 2.1 Important Administration Instructions See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection. Table 1. Amounts of Calcium Gluconate and Elemental Calcium Total Strength per Total Volume Strength per mL Elemental Calcium (mg) per mL Elemental Calcium (mEq) per mL Total Amount of Elemental Calcium (mg) per Total Volume Total Amount of Elemental Calcium (mEq) per Total Volume 1,000 mg per 50 mL 20 mg/mL 1.86 mg 0.093 mEq 93 mg per 50 mL 4.65 mEq per 50 mL 1,000 mg per 100 mL 10 mg/mL 0.93 mg 0.0465 mEq 93 mg per 100 mL 4.65 mEq per 100 mL 2,000 mg per 100 mL 20 mg/mL 1.86 mg 0.093 mEq 186 mg per 100 mL 9.3 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. • Administer Calcium Gluconate in Sodium Chloride Injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions (5.3)]. Administer Calcium Gluconate in Sodium Chloride Injection by continuous infusion at the rate recommended in Table 1 [see Dosage and Administration (2.2)] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings and Precautions (5.4)] . 2.2 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. Dosing Recommendations in mg of Calcium Gluconate for Neonate, Pediatric, and Adult Patients PatientPopulation Initial Dose Subsequent Doses (if needed) Bolus Continuous Infusion Neonate (less than1 month to 1 month) 100 mg/kg to 200 mg/kg 100 mg/kg to 200 mg/kg every 6 hours Initiate at 17 mg/kg/hour to 33 mg/kg/hour Pediatric (greater than 1 month to less than 17 years) 29 mg/kg to 60 mg/kg 29 mg/kg to 60 mg/kg every 6 hours Initiate at 8 mg/kg/hour to 13 mg/kg/hour Adult (17 years and greater) 1,000 mg to 2,000 mg 1,000 mg to 2,000 mg every 6 hours Initiate at 5.4 mg/kg/hour to 21.5 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 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. 2.4 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. 2.5 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. Concomitant use of ceftriaxone and intravenous calcium-containing products is contraindicated in neonates (28 days of age or younger) [see Contraindications (4)] . In patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. Ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions via a Y-site in any age group [see Warnings and Precautions (5.2), Drug Interactions (7.3)]. • Do not mix Calcium Gluconate in Sodium Chloride Injection with fluids containing bicarbonate or phosphate. Calcium Gluconate Injection is not physically compatible with fluids containing phosphate or bicarbonate. Precipitation may result if mixed. • Do not mix Calcium Gluconate in Sodium Chloride Injection with minocycline injection. Calcium complexes minocycline rendering it inactive.

8.4 Pediatric Use The safety and effectiveness of Calcium Gluconate in Sodium Chloride Injection have been established in pediatric patients for the treatment of acute, symptomatic hypocalcemia. Pediatric approval for Calcium Gluconate in Sodium Chloride Injection, including doses, is not based on adequate and well-controlled clinical studies. Safety and dosing recommendations in pediatric patients are based on published literature and clinical experience [see Dosage and Administration (2.2)] . Concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates (28 days of age or younger) due to reports of fatal outcomes associated with the presence of lung and kidney ceftriaxone-calcium precipitates. In patients older than 28 days of age, ceftriaxone and Calcium Gluconate Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid [ see Contraindications (4) and Warnings and Precautions (5.2)] . This product contains up to 25 mcg/L aluminum which may be toxic, particularly for premature neonates due to immature renal function. Parenteral administration of aluminum greater than 4 mcg/kg/day to 5 mcg/kg/day is associated with central nervous system and bone toxicity [see Warnings and Precautions (5.5)] .