Edetate Calcium Disodium (edetate calcium disodium)

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Edetate calcium disodium may be administered by slow IV infusion or by IM injection. Daily doses of the drug are preferably administered by IV infusion over 12-24 hours. Although IM administration has been recommended by some clinicians as the preferred route of administration in young children (since IV administration of the drug has been associated with fatality in some young children) and in patients with lead encephalopathy and cerebral edema (and may be necessary in the latter patients if fluid restrictions preclude IV infusion), most experts currently recommend IV administration whenever possible. In addition, the American Academy of Pediatrics (AAP) states that clinical experience suggests that IV administration of edetate calcium disodium is safe and more appropriate for children than the IM route. If edetate calcium disodium is administered IV in patients with lead encephalopathy and cerebral edema, the drug must be infused slowly since rapid infusions may increase intracranial pressure to lethal levels.

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There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Intravenous Calcium Products/Digitalis Glycosides

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The mechanism of action of digitalis glycosides involves its ability to cause an increase in excitation-contraction coupling mediated through the effects of calcium. Excitable tissues in the heart experience inhibition of sodium/potassium ATPase (the membrane "sodium pump") by digitalis glycosides and so attain relatively higher intracellular sodium and lower potassium concentrations. Higher intracellular sodium concentrations facilitate exchange of extracellular calcium ions and the inward and internal flux of calcium results in modified transmembrane potentials and stronger contractions of cardiac muscle. Elevated extracellular concentrations of calcium after parenteral calcium salts further facilitate these inward calcium fluxes.

CLINICAL EFFECTS: Rapid administration of calcium via the intravenous route may result in digitalis toxicity, including arrhythmias.(1)

PREDISPOSING FACTORS: Low body weight, advanced age, impaired renal function, hypokalemia, hypercalcemia, and/or hypomagnesemia may increase the risk of digoxin toxicity.

PATIENT MANAGEMENT: In patients maintain on a digitalis glycosides, administer intravenous calcium slowly and with caution. If cardiac toxicity develops, supportive measures without additional antiarrhythmics may be sufficient.

DISCUSSION: Effects of digitalis glycosides on the heart are increased by elevated extracellular concentrations of ionic calcium. Intravenous administration of calcium salts during digitalis therapy may result in altered cardiac electrophysiologic activity such as tachycardia or arrhythmias. Oral calcium carbonate has not been shown to affect the bioavailability of oral digitalis.

Intravenous Calcium Products/Intravenous Ceftriaxone

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Intravenous ceftriaxone and intravenous calcium may form an insoluble precipitate if administered too closely together.

CLINICAL EFFECTS: Intravenous administration of calcium-containing products with intravenous ceftriaxone may have serious risks in all patients, especially in the neonate population. NEONATES: Intravenous administration of calcium-containing products within 48(1-2) to 120(3) hours of intravenous administration of ceftriaxone may result in damage to the lungs and/or kidneys in neonates. Fatalities in neonates have been reported.(1-7) OLDER CHILDREN and ADULTS: Sequential administration requires proper line flushing. Use within 48 hours may result in the formation of kidney stones in older children(5) and the formation of "sludge" in the gallbladder.(2) Simultaneous administration in patients older than 28 days may result in the formation of an insoluble ceftriaxone-calcium precipitate.(1-7)

PREDISPOSING FACTORS: Neonates, both preterm and term, may be a greatest risk of death from this interaction.(1-4) Young age may predispose patients to formation of ceftriaxone-calcium precipitates in the kidney.(5) High doses of ceftriaxone may also increase the risk of precipitates.(6)

PATIENT MANAGEMENT: The US manufacturer of ceftriaxone, Health Canada, and the US Food and Drug Administration (FDA) state that the concomitant use of ceftriaxone and intravenous calcium-containing products is contraindicated in neonates less than or equal to 28 days of age. Ceftriaxone should not be used in neonates less than or equal to 28 days of age if they are receiving or are expected to receive calcium-containing intravenous products.(2,3,7) The US manufacturer of ceftriaxone, Health Canada, and the US FDA state that in patients older than 28 days of age, ceftriaxone and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.(2,3,7) The US manufacturer of ceftriaxone, Health Canada, and the US FDA state that ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions via a Y-site in any age group.(2,3,7)

DISCUSSION: Isolated reports of neonatal (both term and preterm infants) deaths have been associated with ceftriaxone-calcium precipitates in the lungs and kidneys. A total of 7 cases have been reported to the FDA, resulting in 5 deaths. All 5 deaths were in neonates of 3 weeks or less in age. Six of the 7 patients received calcium gluconate, 1 received calcium via hyperalimentation.(6) In some cases, ceftriaxone and the calcium product were administered by different routes,(1) lines,(2) and/or at different times.(1,2) Reports of a ceftriaxone-calcium salt precipitate in the gall-bladder have also been reported.(2) In in vitro studies in adult and neonatal plasma, ceftriaxone recovery was examined with ceftriaxone concentrations up to 1 mM (in excess of concentrations seen with 2 g ceftriaxone infused over 30 minutes) and calcium concentrations up to 12 mM (48 mg/dL). Ceftriaxone recovery was reduced with calcium concentrations of 6 mM (24 mg/dL) in adult plasma and 4 mM (16 mg/dL) in neonatal plasma. This may indicate ceftriaxone-calcium precipitation formation.(2,7) There have been no reports associated with concurrent use of oral calcium products and the US manufacturer of ceftriaxone states that there is no risk with oral calcium products or use of intramuscular ceftriaxone.(4)

There are no moderate interactions for this drug.

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• Anuria
• Hepatitis
• Oliguria

• Cerebral edema
• Dehydration
• Kidney disease with reduction in glomerular filtration rate (GFr)

• Hypercalcemia

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More Frequent

• Anorexia
• Chills
• Eye tearing
• Fatigue
• Fever
• Headache disorder
• Hypotension
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Malaise
• Nasal congestion
• Nausea
• Renal tubular necrosis
• Sneezing
• Thrombophlebitis
• Vomiting

Less Frequent

• Anemia
• Bone marrow depression
• Hypercalcemia
• Skin fissure
• Skin rash
• Skin scaling

Rare or Very Rare

• Gout
• Hypokalemia
• Increased urinary frequency
• Intracranial hypertension
• Urinary urgency

Rare or Very Rare

• Hematuria
• Polydipsia
• Proteinuria

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A reproduction study in rats using edetate calcium disodium dosages up to about 13 times the usual human dosage has not revealed evidence of harm to the fetus; however, dosages up to 25-40 times the usual human dosage in rats were associated with fetal malformations. Fetal malformations were prevented in rats receiving zinc supplementation. There are no adequate and controlled studies to date using edetate calcium disodium in pregnant women, and the drug should be used during pregnancy only when clearly needed. The effect of edetate calcium disodium on labor and delivery is not known.

Since it is not known whether edetate calcium disodium is distributed into human milk, the drug should be used with caution in nursing women.

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