Label Changes for:

Ceftriaxone for Injection and Dextrose Injection

May 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Neonates (<28 days)

WARNINGS

  • Hypersensitivity
  • Interaction with Calcium-Containing Products
  • Clostridium difficile

PRECAUTIONS

  • Pediatric Use
    • ...Ceftriaxone for Injection and Dextrose Injection should not be administered...

ADVERSE REACTIONS

  • Local Reactions
    • Pain, induration and tenderness was 1% overall ...
  • Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described...

CONTRAINDICATIONS

Neonates (<28 days)
Hyperbilirubinemic neonates, especially prematures, should not be treated with Ceftriaxone for Injection and Dextrose Injection. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in these patients.

Ceftriaxone for Injection and Dextrose Injection must not be co-administered with calcium containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition, in neonates because of the risk of precipitation of ceftriaxone-calcium salt. Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and the times of administration of ceftriaxone and calcium-containing solutions differed.

WARNINGS

Interaction with Calcium-Containing Products

There are no reports to date of intravascular or pulmonary precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing IV solutions. However, the theoretical possibility exists for an interaction between ceftriaxone and IV calcium-containing solutions in patients other than neonates. Therefore, Ceftriaxone for Injection and Dextrose Injection and calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites. As a further theoretical consideration and based on 5 half-lives of ceftriaxone, Ceftriaxone for Injection and Dextrose Injection and IV calcium-containing solutions should not be administered within 48 hours of each other in any patient...

No data are available on potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

Label approved 05/08/2008 is not available on Drugs@FDA

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