tedizolid phosphate

FDA Drug Profile — SIVEXTRO

Drug Details

Generic Name
tedizolid phosphate
Brand Names
SIVEXTRO
Application Number
NDA205436
Sponsor
Patheon Inc.
NDC Codes
4
Dosage Forms
TABLET, COATED, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, TABLET, FILM COATED
Routes
INTRAVENOUS, ORAL
Active Ingredients
TEDIZOLID PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE SIVEXTRO is an oxazolidinone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible microorganisms in adult and pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg) ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria 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 or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Acute Bacterial Skin and Skin Structure Infections SIVEXTRO ® is 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 , in adult and pediatric patients (at least 26 weeks gestational age and weighing at least 1 kg). 1.2 Usage to Reduce Development of Drug-Resistant Bacteria 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 or prevent infections that are proven or strongly suspected to be caused by 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.