Linezolid

LINEZOLID- linezolid injection, solution
Hikma Pharmaceuticals USA Inc.

1 INDICATIONS AND USAGE

1.1 Nosocomial Pneumonia

Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14) ].

1.2 Community-acquired Pneumonia

Linezolid is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14) ].

1.3 Complicated Skin and Skin Structure Infections

Linezolid is indicated for 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. Linezolid has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14) ].

1.4 Uncomplicated Skin and Skin Structure Infections

Linezolid is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14) ].

1.5 Vancomycin-resistant Enterococcus faecium Infections

Linezolid is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14) ].

1.6 Limitations of Use

  • Linezolid 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) ].

  • The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14) ].

1.7 Usage

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

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

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

Table 1. Dosage Guidelines for Linezolid

Infection*

Dosage and Route of Administration

Recommended Duration of Treatment (consecutive days)

Pediatric Patients(Birth through 11 Years of Age)

Adults and Adolescents (12 Years and Older)

Nosocomial pneumonia

10 mg/kg intravenously or oral every 8 hours

600 mg intravenously 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 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 to 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

* 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 linezolid tablets or linezolid oral suspension [see How Supplied/Storage and Handling (16) ].

No dose adjustment is necessary when switching from intravenous to oral administration.

2.2 Intravenous Administration

Linezolid injection is supplied in single-dose, 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. Store at room temperature. Protect from freezing. Linezolid injection may exhibit a yellow color that can intensify over time without adversely affecting potency.

Linezolid 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 linezolid 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. Discard unused portion.

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

2.3 Compatibilities

Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer’s Injection, USP.

2.4 Incompatibilities

Physical incompatibilities resulted when linezolid injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when linezolid injection was combined with ceftriaxone sodium.

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