LINEZOLID- linezolid suspension
Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ].
Linezolid is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ].
Linezolid is indicated for the treatment of 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 has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ].
Linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14) ].
Linezolid is indicated for the treatment of vancomycin– resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14) ].
- Linezolid is 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) ].
- The safety and efficacy of linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14) ].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid and other antibacterial drugs, linezolid 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 recommended dosage for linezolid formulations for the treatment of infections is described in Table 1.
|Infection *||Dosage, Route and Frequency of Administration||Recommended Duration of Treatment (consecutive days)|
|Pediatric Patients † (Birth through 11 Years of Age)||Adults and Adolescents (12 Years and Older)|
|Community-acquired pneumonia, including concurrent bacteremia||10 mg/kg intravenously or oral ‡ every 8 hours||600 mg intravenously or oral ‡ every 12 hours||10 to 14|
|Complicated skin and skin structure infections|
|Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia||10 mg/kg intravenously or oral ‡ every 8 hours||600 mg intravenously or oral ‡ every 12 hours||14 to 28|
|Uncomplicated skin and skin structure infections||less than 5 yrs: 10 mg/kg oral ‡ every 8 hours 5–11 yrs: 10 mg/kg oral ‡ every 12 hours||Adults: 400 mg oral ‡ every 12 hours Adolescents: 600 mg oral ‡ every 12 hours||10 to 14|
No dose adjustment is necessary when switching from intravenous to oral administration.
Linezolid for Oral Suspension is supplied as a powder/granule for constitution. Gently tap bottle to loosen powder. Add a total of 123 mL distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After constitution, each 5 mL of the suspension contains 100 mg of linezolid. Before using, gently mix by inverting the bottle 3 to 5 times. Do not shake. Store constituted suspension at room temperature. Use within 21 days after constitution.
Linezolid for Oral Suspension: dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL.
Linezolid formulations are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.
Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product.
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibacterial drug therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression.
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