FDA
Calcium Gluconate in Sodium Chloride
The FDA lists this product in 9 strengths and forms.
Indications
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)
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)
Warnings and precautions
- 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)
- 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 Injection via a Y-site in any age group. 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 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)
- 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)