Linezolid

ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia, Community-acquired pneumonia, Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, Uncomplicated skin and skin structure infections, Vancomycin-resistant Enterococcus faecium infections. Limitations of Use: • ZYVOX is not indicated for the treatment of Gram-negative infections. • The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

ZYVOX is an antibacterial drug.

Dosage, Route, and Frequency of Administration Infection Pediatric Patients (Birth through 11 years of Age) Adults and Adolescents (12 years and Older) Duration (days) Nosocomial pneumonia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous or oral every 12 hours 10 to 14 Community-acquired pneumonia, including concurrent bacteremia Complicated skin and skin structure infections Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 10 mg/kg intravenous or oral every 8 hours 600 mg intravenous 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

• Known hypersensitivity to linezolid or any of the other product components. • Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI.

• Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. • Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. • Serotonin Syndrome: Monitor patients taking ZYVOX concomitantly with serotonergic agents for signs of serotonin syndrome. If signs or symptoms of serotonin syndrome occur, consider discontinuing ZYVOX and/or concomitant serotonergic agents. • A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Myelosuppression • Peripheral and Optic Neuropathy • Serotonin Syndrome • Clostridioides difficile -Associated Diarrhea • Lactic Acidosis • Convulsions • Rhabdomyolysis • Hypoglycemia • Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) Most common adverse reactions (>5% of adult and/or pediatric patients treated with ZYVOX) include diarrhea, vomiting, headache, nausea, and anemia.

Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. Monoamine Oxidase Inhibitors Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Adrenergic and Serotonergic Agents Linezolid has the potential for interaction with adrenergic and serotonergic agents.

Store at 25ºC (77ºF). Protect infusion bags from freezing. Protect from light. Keep bottles tightly closed to protect from moisture.