Calcium Gluconate

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. Calcium gluconate injection is a form of calcium indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. ( 1 ) Limitations of Use: The safety of calcium gluconate injection for long term use has not been established. ( 1 )

• Contains 100 mg of calcium gluconate per mL which contains 9.3 mg (0.465 mEq) of elemental calcium
• Administer intravenously (bolus or continuous infusion) via a secure intravenous line
• See Full Prescribing Information (FPI) for dilution instructions, administration rates and appropriate monitoring
• 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
• Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours
• Calcium gluconate injection is not physically compatible with fluids containing phosphate or bicarbonate
• Precipitation may result if mixed
• See FPI for all drug incompatibilities
• Supplied in a single-dose vial or pharmacy bulk package (PBP)
• For PBP, dispense single-doses to many patients in a pharmacy admixture program; use within 4 hours of puncture
• 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 intravenous fluid incompatibilities [see Dosage and Administration ]

Calcium Gluconate Injection, USP is a sterile, 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, USP contains 9.3 mg (0.465 mEq) of elemental calcium. …

• Advise the patient that the risks associated with infusion including local tissue inflammation, local necrosis and calcinosis [see Warnings and Precautions ]
• Manufactured by: Amneal Pharmaceuticals Pvt
• Parenteral Unit Ahmedabad 382110, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 12-2023-01

• Calcium gluconate 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

Cardiac Glycoside : Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. ( 7.1 ) Calcium Channel Blockers : Administration of calcium may reduce the response. ( 7.2 ) Drugs that may cause hypercalcemia: Vitamin D, vitamin A, thiazide diuretics, estrogen, calcipotriene and teriparatide administration may cause hypercalcemia. Monitor plasma calcium concentrations in patients taking these drugs concurrently. ( 7.3 ) 7.1 Cardiac Glycosides Hypercalcemia increases the risk of digoxin toxicity, while digoxin may be therapeutically ineffective in the presence of hypocalcemia. …

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) 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, 5.2) 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. …

The following serious adverse reactions are also described elsewhere in the labeling: Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions (5.1) ] End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions (5.2) ] Tissue Necrosis and Calcinosis [see Warnings and Precautions (5.3) ] Hypotension, Bradycardia and Cardiac Arrhythmias [see Warnings and Precautions (5.4) ] Aluminum toxicity [see Warnings and Precautions (5.5) ] The following adverse reactions associated with the use of calcium gluconate were identified in the literature. …

IN SPECIFIC POPULATIONS Geriatric use : Dosing in elderly patients should be cautious, usually starting at the low end of the dosage range. ( 8.5 ) Renal impairment: Initiate with the lower limit of the dosage range and monitor serum calcium levels every 4 hours. …

Overdosage of calcium gluconate injection may result in hypercalcemia. Symptoms of hypercalcemia typically develop when the total serum calcium concentration is ≥ 12 mg/dL. Neurologic symptoms include depression, weakness, fatigue and confusion at lower levels, with patients experiencing hallucinations, disorientation, hypotonicity, seizures and coma. Effects on the kidney include diminished ability to concentrate urine and diuresis. …

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