Postmarketing experience: In phase III clinical trial and post marketing surveillance study, few adverse events were observed of which details are given below: Summary of safety profile: There were no serious adverse event observed in the studies conducted so far on Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion. In these studies, the most common adverse effect following administration of Ceftriaxone sodium, Sulbactam sodium, and Disodium edetate are pain at the site of injection, nausea, vomiting, headache, and dizziness. These adverse events were related to ceftriaxone/sulbactam.
Description of selected adverse reactions: Out of the above adverse events, pain at site of injection was most common adverse event observed during the trial. This adverse event was of mild to moderate intensity and last for 2 to 3 days after the intravenous administration of Ceftriaxone/Sulbactam 1.5 g/Vial Powder for Solution for Injection/Infusion.
Frequently reported adverse events: Elores is generally well tolerated. Other frequently reported adverse events related to ceftriaxone/sulbactam which were considered to be related to Cephalosporin therapy or of uncertain etiology, may occur.
Local reactions: Pain, induration and tenderness was 1% overall. Phlebitis was reported in < 1% after IV administration.
Hypersensitivity: Rash (1.7%). Less frequently reported (<1% ) were pruritus, fever or chills.
Hematologic: Eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.
Gastrointestinal: Diarrhea (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.
Hepatic: Elevations of SGOT (3.1%) or SGPT (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin.
Renal: Elevations of the BUN (1.2%). Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine.
Central nervous system: Headache or dizziness were reported occasionally (<1%).
Genitourinary: Moniliasis or vaginitis were reported occasionally (<1%).
Miscellaneous: Diaphoresis and flushing were reported occasionally (<1%).
Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.