Calcium Gluconate - Calcium Gluconate injection, Solution

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

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

• Contains 100 mg of calcium gluconate per mL which contains 9.3 mg (0.465 mEq) of elemental calcium (
  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.
  )
• Administer intravenously (bolus or continuous infusion) via a secure intravenous line (
  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.
  )
• See Full Prescribing Information (FPI) for dilution instructions, administration rates, and appropriate monitoring (
  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.
  )
• 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 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 1provides 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
  )
• Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. (
  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.
  )
• 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 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.
  )
• Supplied in a single-dose vial.

Calcium Gluconate Injection, USP is a clear, colorless to slightly yellow, solution free from visible particles available in the following:

• Single dose vial: 1,000 mg per 10 mL (100 mg per mL)

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

• Geriatric use
  : Dosing in elderly patients should be cautious, usually starting
   
  at the low end of the dosage range. (
  8.5 Geriatric Use

  In general dose selection for an elderly patient should start at the lowest dose of the recommended dose range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  )
• Renal impairment:
  Initiate with the lower limit of the dosage range and monitor serum calcium levels every 4 hours. (
  8.6 Renal Impairment

  For patients with renal impairment, initiate Calcium Gluconate Injection at the lowest dose of the recommended dose ranges across all age groups. Monitor serum calcium levels every 4 hours

  [see Dosage and Administration (2.4)].
  ,
  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.
  )

• 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 (
  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 Inte ractions (7.1)]

  .
  )
• 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. (
  4 CONTRAINDICATIONS

  Calcium Gluconate Injection is contraindicated in:

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

  • Hypercalcemia
  • Neonates (28 days of age or younger) receiving ceftriaxone
  ,
  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.
  )
• 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. (
  5.3 Tissue Necrosis and Calcinosis

  Intravenous administration of Calcium Gluconate Injection and local trauma may result in calcinosis cutis due to transient increase in local calcium concentration. Calcinosis cutis can occur with or without extravasation of Calcium Gluconate Injection, is characterized by abnormal dermal deposits of calcium salts, and clinically manifests as papules, plaques, or nodules that may be associated with erythema, swelling, or induration. 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.
  )
• 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. (
  5.4 Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration

  Rapid injection of Calcium Gluconate Injection may cause vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmias, syncope and cardiac arrest. 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. If rapid intravenous bolus of Calcium Gluconate Injection is required, the rate of intravenous administration should not exceed 200 mg/minute in adults and 100 mg/minute in pediatric patients and ECG monitoring during administration is recommended

  [see

  Dosage and Administration (2.1)]

  .
  )
• Aluminum Toxicity:
  This product contains aluminum, up to 400 mcg per liter, that may be toxic. (
  5.5 Aluminum Toxicity

  Calcium Gluconate Injection contains aluminum, up to 400 mcg per liter, that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 mcg/kg/day to 5 mcg/kg/day accumulate aluminum levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
  )