Calcium Chloride Dihydrate

Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia.

The safety and effectiveness of calcium chloride injection for long-term use has not been established.

• Administer calcium chloride injection
  by

  slow

  intravenous infusion (not to exceed 1 mL/minute),

  in a central or deep vein.
  (2.1)
• Do not use intramuscularly or subcutaneously. (2.1)
• Do not administer unless solution is clear and seal is intact. (2.1)
• Stop the administration if the patient complains of any administration- related discomfort, it may be resumed when symptoms disappear. (2.1)
• The recommended adult dose is from 200 mg to 1,000 mg. (2.2)
• The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium chloride. (2.2)
• Repeated injections may be required because of rapid calcium excretion. (2.2)
• See the full prescribing information for the recommended starting dose in patients with renal impairment. (2.3)
• Do not mix calcium chloride Injection with ceftriaxone or administer these products simultaneously via a Y-site because concurrent use can lead to the formation of ceftriaxone-calcium precipitates. (2.4)

Calcium chloride injection, USP (single-dose) supplied as:

•   10% (1,000 mg/10 mL) (100 mg/mL) in a 10 mL vial

The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution.

Administration of calcium chloride injection for the treatment of acute symptomatic hypocalcemia during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with development of hypocalcemia during pregnancy

The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Infants born to mothers with hypocalcemia can develop fetal and neonatal hyperparathyroidism, which in turn can cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica and neonatal seizures.

• End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates:
  Calcium chloride injection is contraindicated in newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment. In patients older than 28 days of age, do not mix or administer simultaneously with ceftriaxone intravenous solutions, even via different infusion lines or at different infusion sites as it can lead to precipitation of ceftriaxone-calcium. (5.1)
• Hypotension, Bradycardia, Arrhythmias, and Syncope with Rapid Administration:
  Too rapid an injection exceeding 1 mL/minute may lead to hypotension and syncope. (2.1, 5.2)
• Arrhythmias with Concomitant Digoxin Use:
  Avoid use of calcium chloride injection in patients receiving digoxin. Closely monitor ECG and calcium levels if concomitant therapy is necessary. (5.3, 7.1)
• Tissue Necrosis and Calcinosis:
  Administer calcium chloride injection slowly through a small needle into a large vein to minimize the risk of tissue necrosis, ulceration and calcinosis. Avoid extravasation or accidental injection into perivascular tissues. Immediately discontinue administration should perivascular infiltration occur. (2.1, 5.4)
• Aluminum Toxicity:
  Risk of toxicity with prolonged administration if kidney function is impaired. Premature neonates are particularly at risk. When prescribing calcium chloride injection in patients receiving parenteral nutrition solutions, limit the total daily patient exposure to aluminum to no more than 5 mcg/kg/day. (5.5)