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IMPORTANT SAFETY INFORMATION AND INDICATIONS

ZYVOX should not be used if you have any known allergies or hypersensitivity to linezolid or any of the other product components.

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

Before you use ZYVOX talk to your doctor if you have a history of anemia (low hemoglobin), thrombocytopenia (low platelets), neutropenia (low white blood cells), a history of bleeding problems, or any other blood related disorders.

Tell your doctor if you experience changes in vision as nerve injury has been reported in patients taking ZYVOX longer than 28 days. You may want to undergo an eye examination to see if you are at risk and discuss the continued use of ZYVOX with your doctor.

Before taking ZYVOX, tell your doctor if you take a serotonin re-uptake inhibitor (SSRI) for depression or other antidepressants. Taking ZYVOX with antidepressants can cause serious or even life-threatening side effects. Do not take ZYVOX within 14 days of stopping an antidepressant SSRI.

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. Tell your doctor right away if you experience severe diarrhea, even after you have stopped taking ZYVOX.

You may need to be monitored for increases in blood pressure. Tell your doctor about all the medical conditions you have or had including uncontrolled high blood pressure or history of hypertension.

Tell your doctor about all the prescription and over the counter medications you are taking or plan to take including cold remedies and decongestants such as pseudoephedrine HCl or phenylpropanolamine HCl.

Tell your doctor or seek medical attention if you experience repeated episodes of nausea and vomiting.

Tell your doctor if you have had a seizure or have a history of seizures.

If you are a diabetic patient tell your doctor right away if you have symptoms of low blood sugar (hypoglycemia) including severe sweating, nervousness along with a low blood sugar reading when measuring blood sugar.

ZYVOX may react with a substance, which is naturally present in some foods called tyramine. Foods or beverages with high tyramine content should be avoided while taking ZYVOX. Foods high in tyramine content include those that may have undergone protein changes by aging, fermentation, pickling, or smoking to improve flavor, such as aged cheeses; fermented or air-dried meats; sauerkraut; soy sauce; tap beers; red wines. The tyramine content of any protein-rich food may be increased if stored for long periods or improperly refrigerated.

The most commonly reported side effects were diarrhea, nausea, and headache.

ZYVOX is only used to treat bacterial infections. It does not treat viral infections such as the common cold. Take ZYVOX exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by ZYVOX or other antibacterial drugs in the future.

INDICATIONS

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

Nosocomial pneumonia (pneumonia acquired in the hospital) 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 (a bone infection at the same time), caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae.

ZYVOX has not been studied in the treatment of decubitus (pressure) ulcers.

Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia (blood stream infections at the same time).

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

Community-acquired pneumonia (pneumonia acquired outside the hospital) caused by Streptococcus pneumoniae, including cases with concurrent bacteremia (blood stream infection), 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 infections that are proven or strongly suspected to be caused by susceptible bacteria.

Please see Full Prescribing Information.

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