ZYVOX Indications

ZYVOX formulations are indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms. 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.

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae.

Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOX has not been studied in the treatment of decubitus ulcers.

Vancomycin-Resistant Enterococcus faecium infections, including cases with concurrent bacteremia.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.

Community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX 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.

Important Safety Information

ZYVOX use is contraindicated in patients with known hypersensitivity to linezolid or any of the other product components.

ZYVOX should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within 2 weeks of taking any such product.

Unless patients are monitored for potential increases in blood pressure, ZYVOX should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following: directly and indirectly acting sympathomimetic, vasopressive, and dopaminergic agents.

Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, ZYVOX should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists, meperidine, or buspirone.

Spontaneous reports of serotonin syndrome have been reported with the coadministration of ZYVOX and serotonergic agents. If signs or symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination occur, discontinuation of one or both agents should be considered.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX. In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive ZYVOX, particularly in those who receive ZYVOX 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 antibiotic therapy. Discontinuation of therapy with ZYVOX should be considered in patients who develop or have worsening myelosuppression.

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

ZYVOX has no clinical activity against Gram-negative pathogens and 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.

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

Postmarketing cases of 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. Some MAO inhibitors have been associated with hypoglycemic episodes in diabetic patients receiving insulin or hypoglycemic agents. While a causal relationship between linezolid and hypoglycemia has not been established, diabetic patients should be cautioned of potential hypoglycemic reactions when treated with linezolid.

Lactic acidosis has been reported with the use of ZYVOX. Patients receiving ZYVOX who develop recurrent nausea, vomiting, unexplained acidosis, or a low bicarbonate level should receive immediate medical evaluation.

Peripheral and optic neuropathy have been reported primarily in patients treated with ZYVOX for longer than the maximum recommended duration of 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended.

Convulsions have been reported in patients treated with ZYVOX. In some of these cases, a history of seizures or risk factors for seizures was reported.

The most commonly reported adverse events in adults across phase 3 clinical trials were diarrhea, nausea, and headache.

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