Gracevit® is the commercial brand name of Sitafloxacin Tablets, developed by Shionogi. It is an oral broad-spectrum fluoroquinolone antibacterial agent. It inhibits bacterial DNA gyrase and topoisomerase IV to block bacterial replication, exerting strong bactericidal activity against gram-positive, gram-negative and anaerobic pathogens.
Main Indications
Treatment of mild to moderate infections caused by susceptible bacteria, including respiratory tract infections, urinary tract infections, biliary tract infections, skin and soft tissue infections.
Clinical Research
Multicenter phase III registration trials fully validated its broad-spectrum antibacterial efficacy against drug-resistant respiratory pathogens;
Head-to-head comparative studies confirmed superior antibacterial activity against atypical bacteria and anaerobes compared with other oral quinolones;
Clinical cohort trials demonstrated fast relief of infectious symptoms and high bacterial eradication rate with once-daily oral administration;
Dose titration research identified the balanced efficacy and safety profile of the 50mg dosage regimen;
Long-term tolerability follow-up trials verified controllable mild adverse reactions during full-course antibacterial treatment.
Common Side Effects
Common mild adverse reactions: Nausea, diarrhea, abdominal distension, dizziness and headache;
Laboratory abnormalities: Rare transient mild elevation of liver transaminases;
Severe but uncommon risks: Severe hypersensitivity reactions, QT interval prolongation, tendon injury and photosensitivity.
Approval Status in China
Original drug Gracevit® (Sitafloxacin Tablets) was officially approved for marketing in China in 2019, with the specification of 50mg, 10 tablets per box. It is currently a prescription antibacterial drug included in China’s Category B medical insurance catalogue.
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