linezolid injection in sodium chloride Dosage and Administration

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2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid injection for the treatment of infections is described in Table 1. No dose adjustment is necessary when switching from intravenous to oral administration.

Table 1. Dosage Guidelines for Linezolid Injection
Dosage, Route, and Frequency of AdministrationRecommended 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)].

Nosocomial pneumonia

10 mg/kg intravenously every 8 hours

600 mg intravenously 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 every 8 hours

600 mg intravenously every 12 hours

14 to 28

The maximum dose for pediatric patients should not exceed the recommended adult dose. The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid injection in a single-dose container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof.

2.2 Intravenous Administration

Linezolid injection is supplied in single-dose, ready-to-use container [see How Supplied/Storage and Handling (16)]. 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 containers 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 container 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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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration

The recommended dosage for linezolid injection for the treatment of infections is described in Table 1. No dose adjustment is necessary when switching from intravenous to oral administration.

Table 1. Dosage Guidelines for Linezolid Injection
Dosage, Route, and Frequency of AdministrationRecommended 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)].

Nosocomial pneumonia

10 mg/kg intravenously every 8 hours

600 mg intravenously 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 every 8 hours

600 mg intravenously every 12 hours

14 to 28

The maximum dose for pediatric patients should not exceed the recommended adult dose. The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid injection in a single-dose container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof.

2.2 Intravenous Administration

Linezolid injection is supplied in single-dose, ready-to-use container [see How Supplied/Storage and Handling (16)]. 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 containers 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 container 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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