Calcium Gluconate - Calcium Gluconate injection, Solution (Calcium Gluconate)

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

• Contains 20 mg of calcium gluconate per mL which contains 1.86 mg (0.093 mEq) of elemental calcium (
  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 1for 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 ].
  • 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 ]
    .
  • Administer Calcium Gluconate in Sodium Chloride Injection by continuous infusion at the rate recommended in Table 2
    [see Dosage and Administration ]
    and monitor patients, vitals, calcium and ECG during the infusion
    [see Warnings and Precautions ]
    .
  • Check solution container composition, lot number, and expiry date.
  • Do not admix with other drugs.
  • Do not use solution containers in series connections.
  • 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:

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

  To Prepare for Administration:

  • Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
  • Use a non-vented infusion set or close the air-inlet on a vented set.
  • Close the roller clamp of the infusion set
  • Hold the base of the BLUE infusion port, twist and push spike until fully inserted.
  • 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.
  • Suspend solution container from hanger hole.
  • For Single Use Only. Discard unused portion.
  )
• Administer intravenously (bolus or continuous infusion) via a secure intravenous line (
  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 1for 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 ].
  • 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 ]
    .
  • Administer Calcium Gluconate in Sodium Chloride Injection by continuous infusion at the rate recommended in Table 2
    [see Dosage and Administration ]
    and monitor patients, vitals, calcium and ECG during the infusion
    [see Warnings and Precautions ]
    .
  • Check solution container composition, lot number, and expiry date.
  • Do not admix with other drugs.
  • Do not use solution containers in series connections.
  • 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:

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

  To Prepare for Administration:

  • Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
  • Use a non-vented infusion set or close the air-inlet on a vented set.
  • Close the roller clamp of the infusion set
  • Hold the base of the BLUE infusion port, twist and push spike until fully inserted.
  • 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.
  • Suspend solution container from hanger hole.
  • For Single Use Only. Discard unused portion.
  )
• See Full Prescribing Information (FPI) for administration rates and appropriate monitoring (
  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 1for 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 ].
  • 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 ]
    .
  • Administer Calcium Gluconate in Sodium Chloride Injection by continuous infusion at the rate recommended in Table 2
    [see Dosage and Administration ]
    and monitor patients, vitals, calcium and ECG during the infusion
    [see Warnings and Precautions ]
    .
  • Check solution container composition, lot number, and expiry date.
  • Do not admix with other drugs.
  • Do not use solution containers in series connections.
  • 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:

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

  To Prepare for Administration:

  • Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
  • Use a non-vented infusion set or close the air-inlet on a vented set.
  • Close the roller clamp of the infusion set
  • Hold the base of the BLUE infusion port, twist and push spike until fully inserted.
  • 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.
  • Suspend solution container from hanger hole.
  • For Single Use Only. Discard unused portion.
  )
• Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. Any unused portion should be discarded (
  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 1for 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 ].
  • 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 ]
    .
  • Administer Calcium Gluconate in Sodium Chloride Injection by continuous infusion at the rate recommended in Table 2
    [see Dosage and Administration ]
    and monitor patients, vitals, calcium and ECG during the infusion
    [see Warnings and Precautions ]
    .
  • Check solution container composition, lot number, and expiry date.
  • Do not admix with other drugs.
  • Do not use solution containers in series connections.
  • 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:

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

  To Prepare for Administration:

  • Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from the solution container.
  • Use a non-vented infusion set or close the air-inlet on a vented set.
  • Close the roller clamp of the infusion set
  • Hold the base of the BLUE infusion port, twist and push spike until fully inserted.
  • 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.
  • Suspend solution container from hanger hole.
  • For Single Use Only. Discard unused portion.
  )
• 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 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/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

  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 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 2provides 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/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 in Sodium Chloride 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 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 ]
    . 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 , Drug Interactions ].
  • 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.
  )

Calcium Gluconate in Sodium Chloride Injection is a clear, colorless solution available in the following:

Injection:

• Calcium gluconate 1,000 mg per 50 mL (20 mg per mL) single-dose container.
• Calcium gluconate 2,000 mg per 100 mL (20 mg per mL) single-dose container.

Each mL of Calcium Gluconate in Sodium Chloride Injection contains 20 mg of calcium gluconate which contains 1.86 mg (0.093 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 in Sodium Chloride 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 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.
  )

• Arrhythmias with Concomitant Cardiac Glycoside Use:
  If concomitant therapy is necessary, Calcium Gluconate in Sodium Chloride 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 in Sodium Chloride Injection should be avoided in patients receiving cardiac glycosides. If concomitant therapy is necessary, Calcium Gluconate in Sodium Chloride Injection should be given slowly in small amounts and with close ECG monitoring

  [see Drug Interactions ]

  .
  )
• End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates:
  Concurrent use of intravenous ceftriaxone may cause life-threatening precipitates. Do not administer ceftriaxone simultaneously with Calcium Gluconate in Sodium Chloride via a Y-site in any age group. Cases of fatal outcomes in neonates have occurred. (
  4 CONTRAINDICATIONS

  Calcium Gluconate in Sodium Chloride Injection is contraindicated in:

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

  • 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 in Sodium Chloride 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 ].

  In patients older than 28 days of age, ceftriaxone and Calcium Gluconate in Sodium Chloride 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 in Sodium Chloride Injection via a Y-site in any age group.
  )
• Tissue Necrosis and Calcinosis:
  Calcinosis cutis can occur with or without extravasation of Calcium Gluconate in Sodium Chloride 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 in Sodium Chloride 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 in Sodium Chloride 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 in Sodium Chloride Injection should be infused slowly, with careful ECG monitoring for cardiac arrhythmias. (
  5.4 Hypotension, Bradycardia, and Cardiac Arrhythmias with Rapid Administration

  Rapid injection of Calcium Gluconate in Sodium Chloride 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 in Sodium Chloride Injection should be 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 ]

  .
  )
• Aluminum Toxicity:
  This product contains aluminum, up to 100 mcg per liter, that may be toxic. (
  5.5 Aluminum Toxicity

  Calcium Gluconate in Sodium Chloride Injection contains aluminum, up to 100 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.
  )