Product Specifications
| Specification | Details |
| Manufacturer / Brand | Fresenius Kabi USA, LLC |
| Manufacturer SKU / Item # | 63323036059 |
| NDC Number | 63323-0360-59 (Box/Tray) / 63323-0360-03 (Vial) |
| Concentration / Strength | 10% (100 mg/mL) |
| Elemental Calcium Content | 9.3 mg (0.465 mEq) elemental calcium per mL |
| Total Content per Vial | 5,000 mg Calcium Gluconate Monohydrate (465 mg / 23.25 mEq) |
| Volume per Unit | 50 mL |
| Container Type | Plastic Single-Dose Vial (SDV) |
| Administration Route | Intravenous (IV) Infusion or Slow IV Injection |
| Formulation | Preservative-Free / Sterile / pH 6.0 to 8.2 |
| Storage Temperature | 20°C to 25°C (68°F to 77°F) (Controlled Room Temperature) |
| Packaging Configuration | 25 Vials per Box / Tray |
| Regulatory Category | Prescription-Only (Rx) |
| HCPCS Code |
Key Features & Clinical Applications
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Acute Hypocalcemia Restoration: Rapid-acting intravenous calcium indicated for pediatric and adult patients to quickly elevate serum calcium levels during severe, symptomatic hypocalcemia (e.g., tetany, post-parathyroidectomy care).
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Cardioprotection in Severe Hyperkalemia: Stabilizes cardiac myocyte membranes to prevent lethal arrhythmias caused by critically elevated potassium levels.
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Hypermagnesemia Antidote: Acts as a direct physiological antagonist to reverse central nervous system and respiratory depression resulting from magnesium toxicity.
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Preservative-Free Solution: Formulated without added preservatives or benzyl alcohol, ensuring compliance across sensitive adult, pediatric, and neonatal populations.
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High-Volume 50 mL Vial: Larger 5,000 mg single-dose format ideal for emergency crash carts, intensive care units, and pharmacy admixture programs.
⚠️ Administration Precaution: Dilute in 5% Dextrose or Normal Saline prior to continuous or intermittent infusion. Administer via slow IV push (not exceeding 200 mg/min in adults or 100 mg/min in pediatrics) or slow infusion. Rapid IV administration can trigger severe hypotension, bradycardia, and cardiac arrhythmias.
⚠️ Extravasation & Necrosis Hazard: Avoid extravasation. Infiltration into soft tissue can cause chemical cellulitis, tissue necrosis, and sloughing. Ensure proper placement of the IV line before starting infusion.
⚠️ Incompatibility Notice: Precipitates readily when combined with solutions containing inorganic phosphate, carbonate, or ceftriaxone. Flush IV lines thoroughly between infusions.
