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Rocephine – Calcium Guidelines Updated

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In new guidance released today, the Food & Drug Administration (FDA) said the antibiotic Rocephin (ceftriaxone) can be administered with calcium-containing products in patients older than 28 days.

According to the FDA’s new guidelines:

  • Concomitant use of Rocephin and intravenous calcium-containing products is contraindicated in neonates (less than 28 days of age).  Rocephin should not be used in neonates less 28 days of age) if they are receiving (or are expected to receive) calcium-containing intravenous products.
  • In patients older than 28 days of age, Rocephin and calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.
  • Rocephin must not be administered simultaneously with intravenous calcium-containing solutions via a Y-site in any age group.
  • The FDA now recommends that Rocephin and calcium-containing products may be used concomitantly in patients older than 28 days of age, using the precautionary steps above because the risk of precipitation is low in this population.  the agency had previously recommended, but no longer recommends, that in all age groups Rocephin and calcium-containing products should not be administered within 48 hours of one another.

These guidelines update two 2007 Rocephin alerts in which the FDA added warnings to the label of  Rocephin  about the risk of crystal formation in both neonates and adults when the drug was used concomitantly with calcium-containing products.

The FDA issued the 2007 Rocephin alerts after its manufacturer, Roche, provided the agency with post-marketing reports of five neonatal deaths related to the interaction between Rocephin and calcium-containing products. According to the reports, the deaths occurred suddenly. In four neonates, Rocephin was co-administered with calcium-containing fluids using the same infusion line and in the fifth neonate Rocephin and calcium gluconate were administered by different routes and at different times (the exact time difference was not reported).  Two autopsies found evidence of crystalline material in the renal and pulmonary vasculature.  In a third neonate there was evidence of a precipitate in the intravenous tubing and the neonate’s death occurred soon after the crystalline material was injected.

In addition to the five post-marketing reports provided by Roche, FDA has received four additional post-marketing reports of interactions between Rocephin and calcium-containing products in patients up to one year of age since the FDA first approved Rocephin in 1984.  Three of the interactions resulted in death; in one instance the patient was receiving parenteral nutrition. An autopsy in one patient revealed evidence of crystals in the lungs.

After the FDA issued the 2007 Rocephin alerts, Roche conducted two in vitro studies to assess the potential for precipitation of Rocephin-calcium when Rocephin and calcium-containing products are mixed in vials and in infusion lines.  According to the FDA, these two in vitro studies were conducted in neonatal  and adult plasma.  Today’s revised guidance is based on the findings of these two studies.

In addition to the new guidance released today, the FDA also reiterated the  previous recommendations and  considerations from the 2007 Rocephin alert:

  • Do not reconstitute or mix Rocephin with a calcium-containing product, such as Ringer’s or Hartmann’s solution or parenteral nutrition containing calcium, because particulate formation can result.
  • There are no data on interactions between IV Rocephin and oral calcium-containing products or between intramuscular Rocephin and IV or oral calcium-containing products.

The new information will be reflected in the sections of the drug’s label dealing with warnings, dosage and administration, contraindications, and clinical pharmacology,  the FDA said.

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