| SFDA Approved Use |
Tigecycline is a tetracycline-class antibacterial drug indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below for patients 18 years of age and older:
Complicated skin and skin structure infections Tigecycline is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. Tigecycline is indicated in patients 18 years of age and older for the treatment of complicated intra- abdominal infections caused by susceptible isolates of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin- susceptible isolates), Staphylococcus aureus (methicillin-susceptible and resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros. Limitations of Use Tigecycline is not indicated for the treatment of diabetic foot infections. A clinical trial failed to demonstrate non-inferiority of Tigecycline for treatment of diabetic foot infections. Tigecycline is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. In a comparative clinical trial, greater mortality and decreased efficacy were reported in Tigecycline -treated patients. Usage To reduce the development of drug-resistant bacteria and maintain the effective of Tigecycline and other antibacterial drugs, Tigecycline should be used only to treat infections that are proven or strongly suspected to be caused by susceptibly bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibly patterns may contribute to the empiric selection of therapy. Appropriate specimens for bacteriology examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline. Tigecycline may be initiated as empiric monotherapy before results of these tests are known |
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