linezolid 600 MG Oral Tablet
1 INDICATIONS AND USAGE Linezolid tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Linezolid tablets are not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4) ] . Linezolid tablets are an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 ); Community-acquired pneumonia ( 1.1 ); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1.2 ); Uncomplicated skin and skin structure infections ( 1.2 ); Vancomycin-resistant Enterococcus faecium infections ( 1.3 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablets and other antibacterial drugs, linezolid tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.4 ) 1.1 Pneumonia Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ] . Community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ] . 1.2 Skin and Skin Structure Infections Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , or Streptococcus agalactiae . Linezolid tablets have not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ] . Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14) ] . 1.3 Vancomycin-resistant Enterococcus faecium Infections Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14) ] . 1.4 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid tablets and other antibacterial drugs, linezolid tablets should be used only to treat or prevent infections 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. The safety and efficacy of linezolid tablets given for longer than 28 days have not been evaluated in controlled clinical trials.
Mylan Institutional Inc.
OVAL YELLOW Mylan L77
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.2 Tablets Linezolid Tablets are available containing 600 mg of linezolid. The 600 mg tablets are yellow, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and L77 on the other side. They are available as follows: NDC 42292-008-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). 16.4 Storage Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Protect from light.
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