Calcium Gluconate

Calcium gluconate in sodium chloride 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.

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.

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.

Calcium gluconate in sodium chloride injection is a sterile, clear, colorless, preservative-free, nonpyrogenic, solution of calcium gluconate, a form of calcium, for intravenous use.

The chemical name of calcium gluconate monohydrate, USP is calcium D-gluconate (1:2) monohydrate. The structural formula is

Molecular formula: C₁₂H₂₂CaO₁₄• H₂O

Molecular weight: 448.39 g/mol

Solubility in water: 3.5 g/100 mL at 25°C

Calcium gluconate monohydrate, USP is a white, crystalline granules or powder. It is soluble in boiling water, sparingly soluble in water and insoluble in alcohol.

Calcium Gluconate in Sodium Chloride Injection is available as 1,000 mg per 50 mL (18.8 mg per mL) or 2,000 mg per 100 mL (18.8 mg per mL) filled in single-dose infusion bags.

Each mL of calcium gluconate in sodium chloride injection contains 20 mg of calcium gluconate (equivalent to 18.8 mg of calcium gluconate and 0.9 mg of calcium saccharate tetrahydrate), 6.75 mg sodium chloride as tonicity adjustor, hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection.

Each mL of calcium gluconate in sodium chloride injection contains 1.86 mg (0.093 mEq) of elemental calcium.

Intravenous administration of calcium gluconate increases serum ionized calcium level. Calcium gluconate dissociates into ionized calcium in plasma. Ionized calcium and gluconate are normal constituents of body fluids.