Hypersensitivity: As with other cephalosporins, anaphylactic reactions with fatal outcome were also reported, even if a patient is not known to be allergic or previously exposed.
Before therapy with Elores is instituted, careful inquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to Ceftriaxone, any other Cephalosporin, or to any Penicillin or other β-lactam drug. This product should be given cutaneously to test Penicillin-sensitive patients or to any patients who have demonstrated some form of allergy. If an allergic reaction occurs, Elores should be discontinued and the appropriate therapy instituted.
Interaction with Calcium-Containing Products: In patients other than neonates, ELORES and calcium-containing solutions may be administered sequentially to one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. Diluents containing calcium, such as Ringer's solution or Hartmann's solution, are not to be used to reconstitute ELORES vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. ELORES must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site because precipitation of ceftriaxone-calcium can occur.
Pseudomembranous colitis has been reported with the use of cephalosporins (and other broad spectrum antibiotics), therefore it is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use. As per the published in-vivo data on ELORES in animal model of C. difficile induced Pseudomembranous colitis, it does not induce colitis, as ELORES neutralizes the toxin produced by C. difficile, still it is advised to be cautious in low immunity patients.
Hemolytic Anemia: An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and Elores is stopped until the etiology is determined.