ZYVOX is indicated for:

Nosocomial Pneumonia:

• The treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and-resistant isolates) or Streptococcus pneumoniae.

Community-Acquired Pneumonia:

• The treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only).

Complicated Skin and Skin Structure Infections:

• 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. ZYVOX has not been studied in the treatment of decubitus ulcers.

Uncomplicated Skin and Skin Structure Infections:

• The treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

Vancomycin-resistant Enterococcus Faecium Infections:

• The treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia.

ZYVOX 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.

The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials. 

Linezolid is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections.

An imbalance in mortality was seen in patients treated with linezolid relative to vancomycin/dicloxacillin/oxacillin in an open-label study in seriously ill patients with intravascular catheter-related infections.

Linezolid has no clinical activity against Gram-negative pathogens and is not indicated for the treatment of Gram-negative infections.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid.

Lactic acidosis has been reported with the use of ZYVOX.

Convulsions have been reported in patients when treated with linezolid.

Serotonin syndrome including fatal cases associated with the co-administration of ZYVOX and serotonergic agents, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), have been reported.

Symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents when treated with linezolid, a reversible, non-selective MAO inhibitor.

Peripheral and optic neuropathies have been reported in patients treated with ZYVOX, primarily in those patients treated for longer than the maximum recommended duration of 28 days.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZYVOX, and may range in severity from mild diarrhea to fatal colitis.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

Phenylalanine can be harmful to patients with phenylketonuria (PKU). ZYVOX for oral suspension contains
phenylalanine, a component of aspartame.

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.

Linezolid should not be administered to patients with carcinoid syndrome or patients taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), meperidine, bupropion, or buspirone.

Linezolid has the potential for interaction with adrenergic and serotonergic agents.

Patients receiving linezolid need to avoid consuming large amounts of foods or beverages with high tyramine content.

Unless patients are monitored for potential increases in blood pressure, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following types of medications: directly and indirectly acting sympathomimetic agents (e.g., pseudoephedrine), vasopressor agents (e.g., epinephrine, norepinephrine), dopaminergic agents (e.g., dopamine, dobutamine).

Available data from published and postmarketing case reports with linezolid use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies: embryo and fetal toxicities.

Linezolid and its metabolites are excreted in the milk of lactating rats. Concentrations in milk were similar to those in maternal plasma. It is not known whether linezolid is excreted in human milk.

GoToSource

• Clostridium difficile infections. GoToSource

• Catheter-related bloodstream infections or catheter-site infections. GoToSource  

• Gram-negative infections. GoToSource

• Febrile neutropenia in people with cancer. GoToSource

• Osteomyelitis. GoToSource

• Mycobacteriosis. GoToSource  

• Central nervous system infections. GoToSource

• Intractable tuberculosis. GoToSource

• Infective endocarditis. GoToSource

Toxic optic neuropathy (visual impairment due to optic nerve damage secondary to a toxic substance). GoToSource

Thrombocytopenia (low blood platelet count), pancytopenia (reduced number of red cells, white cells and platelets) and lactic acidosis (too much acid in the body). GoToSource

Liver injury. GoToSource

Teeth and tongue discoloration. GoToSource  

Use for catheter-related bloodstream infections linked to increased mortality risk. GoToSource

Serotonin syndrome (life-threatening drug interaction). GoToSource

Anemia (low number of red blood cells) and leukopenia (reduced number of white blood cells). GoToSource

Hypoglycemia (low blood sugar), hypertension (high blood pressure) and clostridium difficile associated diarrhea. GoToSource

Seizures. GoToSource

Peripheral neuropathy (dysfunction of nerves outside the spinal cord). GoToSource

Lawsuits filed for serotonin syndrome.