Salbec Adverse Reactions

Sulbactam/cefoperazone is usually well tolerated. The most of adverse drug reactions are mild to moderate in intensity and they are generally transient in the course of treatment. In summarized data from comparative and non­-comparative clinical studies, inclusive nearly 2500 patients, the following adverse drug reactions are observed: Gastrointestinal: As with most of the antibiotics, the most common adverse drug reactions are gastrointestinal. The most common were observed: diarrhea/loose stools - 3.9%, followed by nausea and vomiting - 0.6%.
Dermatological reactions: As with all penicillins and cephalosporins, hypersensitivity is seen, manifested by maculopapular rash - 0.6%, and urticaria - 0.08%. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.
Haematological: Slight decreases in neutrophil count 0.4% (5/1131) have been seen. As with other beta-lactam antibiotics, reversible neutropenia may occur with prolonged administration - 0.5% (9/1696). In some patients, positive direct Coombs' test was observed - 5.5% (15/296) during treatment. Decreased hemoglobins - 0.9% (13/1416) or hematocrits 0.9% (13/1409) have been reported, which is consistent with published literature on other cephalosporins. Transient eosinophilia - 3.5% (40/1130) and thrombocytopenia - 0.8% (11/1414) were observed, as well as hypoprothrombinemia - 3.8% (10/262).
Others: Headache - 0.04%, temperature - 0.5%, pain at the injection site - 0.08%, fever - 0.04%.
Laboratory tests: Transient elevations of liver function enzymes values were observed: ASAT - 5.7% (94/1638), ALAT - 6.2% (95/1529), alkaline phosphatase - 2.4% (37/1518) and bilirubin levels - 1.2% (12/1040).
Local reactions: Sulbactam/cefoperazone is well tolerated after intramuscular administration. Occasionally, transient pain may follow administration by this route. As with others penicillins and cephalosporins, when sulbactam / cefoperazone is administered by intravenous infusion some patients may develop phlebitis (0.1%) at the infusion site.
The following additional adverse drug reactions were observed: General: anaphylactic reaction (including shock).
Cardio-vascular: hypotonia.
Gastrointestinal: pseudomembranous colitis.
Hematology: leucopenia.
Skin/skin appendices: pruritus, Stevens-Johnson syndrome.
Urinary: haematuria.
Vascular: vasculitis.