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.
• ardiac Resuscitation: Use only in cases of documented hypocalcemia, hyperkalemia, hypermagnesemia, or calcium channel blocker toxicity. Routine use of calcium in cardiac resuscitation is not recommended. The American Heart Association (AHA) did not review calcium use in the 2015 Neonatal Resuscitation guidelines; therefore, the 2010 AHA guidelines still apply.

FDA APPROVED INDICATION

Treatment of hypocalcemia when IV route is necessary (eg, neonatal tetany and tetany due to parathyroid deficiency, vitamin D deficiency and alkalosis) and for prevention of hypocalcemic during exchange transfusions. As adjunctive therapy in the treatment of acute symptoms in lead colic. Treatment of magnesium sulfate overdose. In severe hyperkalemia, to combat deleterious effects on ECG function, pending correction of the potassium level in the extracellular fluid. In cardiac resuscitation, particularly after open heart surgery, when epinephrine fails.

PRECAUTIONS

Contraindicated in patients with ventricular fibrillation . Coadministration of ceftriaxone sodium injection with calcium-containing IV solutions (including continuous calciumcontaining infusions such as parenteral nutrition) is also contraindicated due to the risk of precipitation of ceftriaxone-calcium . Rapid administration is associated with bradycardia or 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. Cutaneous necrosis or calcium deposition occurs with extravasation. Bolus infusions by UAC have been associated with intestinal bleeding and lower-extremity tissue necrosis.

ADMINISTRATION

• Cardiac Resuscitation: Administer by slow IV push for cardiac arrest; infuse over 30 to 60 minutes for other indications.May dilute in compatible solution for intermittent infusion or continuous infusion.Infuse through a large vein; central line is preferred Do not exceed rate of injection of 1 mL/minute(Calciu chloride 10 % solution). Do not administer into the cardiac muscle.
• Hypocalcemic Seizure: Infuse IV over 10 to 60 minutes while monitoring for bradycardia.Stop infusion if heart rate is less than 100 beats per minute. Do not give intra-arterially.Warm solution to body temperature.Infuse through a large vein, preferably a central line.

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.