Zyvox

ZYVOX- linezolid tablet, film coated
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

ZYVOX is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. 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 [ see Warnings and Precautions (5.4) ].

1.1 Pneumonia

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [ see Clinical Studies (14) ].

Community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [ see Clinical Studies (14) ].

1.2 Skin and Skin Structure Infections

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 [ see Clinical Studies (14) ].

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [ see Clinical Studies (14) ].

1.3 Vancomycin-resistant Enterococcus faecium Infections

Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [ see Clinical Studies (14) ].

1.4 Usage

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

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for ZYVOX formulations for the treatment of infections is described in Table 1.

Table 1. Dosage Guidelines for ZYVOX
Dosage, Route and Frequency of Administration Recommended Duration of Treatment (consecutive days)
Infection * Pediatric Patients (Birth through 11 Years of Age) Adults and Adolescents (12 Years and Older)
*
Due to the designated pathogens [ see Indications and Usage (1)]
Neonates less than 7 days: Most pre-term neonates less than 7 days of age (gestational age less than 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life [ see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)].
Oral dosing using either ZYVOX Tablets or ZYVOX for Oral Suspension [ see How Supplied/Storage and Handling (16)].
Nosocomial pneumonia
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.

2.2 Intravenous Administration

ZYVOX I.V. Injection is supplied in single-use, ready-to-use infusion bags. Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired . Keep the infusion bags in the overwrap until ready to use. Each overwrap contains a peel-off label. Apply the peel-off label to the infusion bag for barcode scanning before use. Store at room temperature. Protect from freezing. ZYVOX I.V. Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

ZYVOX I.V. Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous infusion bag in series connections. Additives should not be introduced into this solution. If ZYVOX I.V. Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each product.

If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of ZYVOX I.V. Injection with an infusion solution compatible with ZYVOX I.V. Injection and with any other drug(s) administered via this common line.

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