Basic Information
SIVEXTRO FILM-COATED TABLET 200MG
TABLET, FILM COATED
Regulatory Information
SIN14850P
September 16, 2015
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XJ01XX11
Company Information
Active Ingredients
Strength: 200mg
Detailed Information
Contraindications
**4 CONTRAINDICATIONS** SIVEXTRO is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients in the drug product.
Indication Information
**1 INDICATIONS AND USAGE** **1.1 Acute Bacterial Skin and Skin Structure Infections** SIVEXTRO is an oxazolidinone-class antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: _Staphylococcus aureus_ (including methicillin-resistant \[MRSA\] and methicillin-susceptible \[MSSA\] isolates), _Streptococcus pyogenes_, _Streptococcus agalactiae_, _Streptococcus anginosus_ Group (including _Streptococcus anginosus_, _Streptococcus intermedius_, and _Streptococcus constellatus_), and _Enterococcus faecalis_. **1.2 Usage** To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible 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 susceptibility patterns may contribute to the empiric selection of therapy.