Calcium Gluconate

CALCIUM GLUCONATE- calcium gluconate monohydrate injection, solution
Fresenius Kabi USA, LLC

1 INDICATIONS AND USAGE

Calcium Gluconate in Sodium Chloride 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 in Sodium Chloride Injection contains 20 mg of calcium gluconate per mL which contains 1.86 mg (i.e. 0.093 mEq) of elemental calcium. See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection.
Table 1. Amount of Calcium Gluconate and Elemental Calcium
Total Strength per Total Volume Strength 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 93 mg per 50 mL 4.65 mEq per 50 mL
2,000 mg per 100 mL 20 mg/mL 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. [see Dosage and Administration (2.5)].
  • 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 2 [see Dosage and Administration (2.2)] and monitor patients, vitals, calcium and ECG during the infusion [see Warnings and Precautions (5.4)].
  • Check solution container composition, lot number, and expiry date.
  • Do not admix with other drugs.
  • Do not use solution containers in series connections.
  • Do not remove solution container from its overwrap until immediately before use.
  • The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling.

INSTRUCTIONS FOR USE:

  1. Always inspect the solution container before and after removal from the overwrap.
  2. Place the solution container on a clean, flat surface. Remove the solution container from the overwrap.
  3. Check the solution container for leaks by squeezing firmly. If leaks are found, discard.
  4. Do not use if the solution is cloudy or a precipitate is present.

To Prepare for Administration:

  1. Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
  2. Use a non-vented infusion set or close the air-inlet on a vented set.
  3. Close the roller clamp of the infusion set
  4. Hold the base of the BLUE infusion port, twist and push spike until fully inserted.
  5. The BLUE infusion port contains a self-sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.
  6. Suspend solution container from hanger hole.
  7. For Single Use Only. Discard unused portion.

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
Patient Population Initial Dose Subsequent Doses (if needed)
Bolus Continuous Infusion
Neonate (1 month) 100 – 200 mg/kg 100 — 200 mg/kgevery 6 hours Initiate at 17-33 mg/kg/hour
Pediatric (> 1 month to < 17 years) 29 — 60 mg/kg 29 — 60 mg/kgevery 6 hours Initiate at 8-13 mg/kg/hour
Adult 1000 — 2000 mg 1000 — 2000 mgevery 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 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.
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