Calcium Gluconate

CALCIUM GLUCONATE — calcium gluconate monohydrate injection, solution
A-S Medication Solutions

1 INDICATIONS AND USAGE

Calcium Gluconate Injection is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia.

Limitations of Use

The safety of Calcium Gluconate Injection for long term use has not been established.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

• Calcium Gluconate Injection contains 100 mg of calcium gluconate per mL which contains 9.3 mg (i.e., 0.465 mEq) of elemental calcium.
• Dilute Calcium Gluconate Injection prior to use in 5% dextrose or normal saline and assess for potential drug or IV fluid incompatibilities [see Dosage and Administration (2.5)].
• 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.
• Administer Calcium Gluconate Injection intravenously via a secure intravenous line to avoid calcinosis cutis and tissue necrosis [see Warnings and Precautions (5.3)].
• Administer Calcium Gluconate Injection by bolus administration or continuous infusion:

For bolus intravenous administration:

• Dilute the dose [see Dosage and Administration (2.2)] of Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 10-50 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. Monitor patients, vitals and electrocardiograph (ECG) during administration [see Warnings and Precautions (5.4)].

For continuous intravenous infusion:

• Dilute Calcium Gluconate Injection in 5% dextrose or normal saline to a concentration of 5.8-10 mg/mL prior to administration. Administer 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)].
• Calcium Gluconate Injection is supplied in single-dose vials and pharmacy bulk packages [see Dosage and Administration (2.6)].

2.2 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.

Table 1 . Dosing Recommendations in mg of Calcium Gluconate for Neonate, Pediatric, and Adult Patients

Patient Population	Initial Dose	Subsequent Doses (if needed)
		Bolus	Continuous Infusion
Neonate ( ≤ 1 month)	100 – 200 mg/kg	100 — 200 mg/kg every 6 hours	Initiate at 17-33 mg/kg/hour
Pediatric (> 1 month to < 17 years)	29 — 60 mg/kg	29 — 60 mg/kg every 6 hours	Initiate at 8-13 mg/kg/hour
Adult	1000 — 2000 mg	1000 — 2000 mg every 6 hours	Initiate at 5.4 — 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 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 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 Injection with ceftriaxone. Concurrent use of intravenous ceftriaxone and Calcium Gluconate 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 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 Injection with minocycline injection. Calcium complexes minocycline rendering it inactive.

2.6 Preparation of Pharmacy Bulk Package

The pharmacy bulk package (PBP) of Calcium Gluconate Injection is intended for dispensing of single doses to multiple patients in a pharmacy admixture program. Penetrate the container closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. Use the PBP only in a suitable ISO Class 5 work area such as a laminar flow hood (or an equivalent clean air compounding area). Complete dispensing from the pharmacy bulk vial within 4 hours after the container closure is penetrated. Each dose dispensed from the Pharmacy Bulk Package vial must be used immediately.

3 DOSAGE FORMS AND STRENGTHS

Calcium Gluconate Injection is a clear, colorless to slightly yellow, solution available in the following:

• Single dose vial: 1,000 mg per 10 mL (100 mg per mL)
• Single dose vial: 5,000 mg per 50 mL (100 mg per mL)
• Pharmacy bulk package: 10,000 mg per 100 mL (100 mg per mL)

Each mL of Calcium Gluconate Injection contains 9.3 mg (0.465 mEq) of elemental calcium.

4 CONTRAINDICATIONS

Calcium Gluconate Injection is contraindicated in:

• Hypercalcemia
• Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2)]

5 WARNINGS AND PRECAUTIONS

5.1 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. If concomitant therapy is necessary, Calcium Gluconate Injection should be given slowly in small amounts and with close ECG monitoring [see Drug Interactions (7.1)].

5.2 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. 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 Injection may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid. Do not administer Ceftriaxone simultaneously with Calcium Gluconate Injection via a Y-site in any age group.