Calcium Gluconate 100 mg/mL
Calcium Gluconate · INJECTION, SOLUTION · Caplin Steriles Limited
Calcium Gluconate is a injection, solution containing calcium gluconate at 100 mg/mL, taken intravenous. Manufactured by Caplin Steriles Limited.
Key Facts
- Brand Name
- Calcium Gluconate
- Generic Name
- Calcium Gluconate
- NDC Code (Product)
65145-172- Manufacturer
- Caplin Steriles Limited
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA218840
- Marketing Start
- 05/13/2026
Recall History
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Advanced Pharma Inc.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Specialty Compounding, LLC
Non Sterility: Microbial contamination
W & C dba The Apothecary
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
W & C dba The Apothecary
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Fresenius Kabi USA LLC (FK USA)
Labeling: Missing label
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 in Sodium Chloride Injection for long term use has not been established. • Calcium Gluconate in Sodium Chloride 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)
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer intravenously (bolus or continuous infusion) via a secure intravenous line (2.1) • See Full Prescribing Information (FPI) for administration rates, and appropriate monitoring (2.1) • Do not dilute Calcium Gluconate in Sodium Chloride Injection prior to use. Any unused portion should be discarded (2.1) • 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) • Measure serum calcium during intermittent infusions every 4 to 6 hours and during continuous infusion every 1 to 4 hours. (2.3) • 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) 2.1 Important Administration Instructions See Table 1 for amounts of elemental calcium in Calcium Gluconate in Sodium Chloride Injection. Table 1. Amounts of Calcium Gluconate and Elemental Calcium Tota…
Contraindications
4 CONTRAINDICATIONS Calcium Gluconate in Sodium Chloride Injection is contraindicated in: •Hyperca lcemia • Neonates (28 days of age or younger) receiving ceftriaxone [see Warnings and Precautions (5.2)] • Hypercalcemia (4) • Neonates (28 days of age or younger) receiving ceftriaxone (4)
Drug Interactions
7 DRUG INTERACTIONS • 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. Synergistic arrhythmias may occur if calcium and cardiac glycosides are administered together. Avoid administration of Calcium Gluconate in Sodium Chloride Injection in patients receiving cardiac glycosides; if considered necessary, administer Calcium Gluconate in Sodium Chloride Injection slowly in small amounts and monitor ECG closely during administration. 7.2 Calcium Channel Blockers Administration of calcium may reduce the response to calcium channel blockers. 7.3 Drugs that may cause Hypercalcemia Vitamin D, vitamin A, thiazide diuretics, estrogen, c…
Adverse Reactions
6 ADVERSE REACTIONS 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular : Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, cardiac arrest Administration site reactions : Local soft tissue inflammation, local necrosis, calcinosis cutis and calcification due to extravasation The most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis…
Frequently Asked Questions
What is Calcium Gluconate used for?
Calcium Gluconate contains Calcium Gluconate. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Calcium Gluconate a controlled substance?
Calcium Gluconate is not classified as a controlled substance by the DEA.
What is the generic name for Calcium Gluconate?
The generic name for Calcium Gluconate is Calcium Gluconate. There are 6 other brand versions of Calcium Gluconate.
What is the NDC code for Calcium Gluconate 100 mg/mL?
The NDC (National Drug Code) for Calcium Gluconate 100 mg/mL is 65145-172, listed by Caplin Steriles Limited.