NEODOSE

INDICATIONS

• Acute treatment of neonatal symptomatic hypocalcemia: Treatment and prevention of hypocalcemia, usually defined as a serum ionized calcium concentration less than approximately 4 mg/dL (or total serum calcium less than approximately 7 to 8 mg/dL). Calcium gluconate given at the same elemental calcium dose may be preferred as calcium chloride may cause a metabolic acidosis . Treatment of asymptomatic infants is controversial.

PRECAUTIONS

Calcium salts are contraindicated in patients with ventricular fibrillation or hypercalcemia (or when calcium levels are above normal). Coadministration of ceftriaxone sodium injection with calcium-containing IV solutions (including continuous calcium-containing infusions such as parenteral nutrition) is also contraindicated due to the risk of precipitation of ceftriaxonecalcium. Product contains aluminum that may be toxic with prolonged IV administration and in patients with impaired kidney function. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Studies showed that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Rapid administration is associated with vasodilation, hypotension, bradycardia, syncope, cardiac arrhythmias, and cardiac arrest.

ADVERSE EFFECTS

Precipitate in the infusion line with crystalline deposits in the lungs and kidneys has been reported in some deceased neonates who were coadministered ceftriaxone IV and calciumcontaining fluids, sometimes in the same infusion line. At least one neonatal fatality has been reported following coadministration at different times and with separate infusion lines, though no crystalline deposits were found at autopsy in this neonate. These reports have been confined to neonates.

ADMINISTRATION

• Administer over 10 to 60 minutes while monitoring heart rate. Temporarily stop infusion if bradycardia develops. Avoid intra-arterial infusions of high calcium concentrations. Use caution with the use of an umbilical venous catheter with the tip close to or in the heart .Administer by slow IV push for cardiac arrest. May dilute in compatible solution for intermittent or continuous infusion. Infusion through central line is preferred.
Administer into a large vein through a small needle to avoid hypercalcemia, extravasation, and necrosis.
• Not for IM or subQ use.

MONITORING

If possible, measure ionized calcium directly. Avoid hypercalcemia during treatment. Correct hypomagnesemia if present. Observe IV infusion site closely for extravasation. Observe IV tubing for precipitates. Monitor continuously for bradycardia when giving bolus doses. Assess for GI intolerance when treating orally.