linezolid injection in sodium chloride Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.

LINEZOLID injection, for intravenous use

Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

9/2023

INDICATIONS AND USAGE

Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4)

Limitations of Use: (1.5)

•
Linezolid is not indicated for the treatment of Gram-negative infections.
•
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration
InfectionPediatric Patients
(Birth through 11 Years of Age)		Adults and Adolescents (12 Years and Older)Duration (days)

Nosocomial pneumonia (1.1)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

10 to 14

Community-acquired pneumonia, including concurrent bacteremia (1.2)

Complicated skin and skin structure infections (1.3)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (1.4)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

14 to 28

•
Pediatric Patients-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. (2.1)

DOSAGE FORMS AND STRENGTHS

Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to linezolid or any of the other product components. (4.1)
•
Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)

WARNINGS AND PRECAUTIONS

•
Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. (5.1)
•
Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. (5.2)
•
Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (5.3)
•
A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (5.4)
•
Clostridioides difficile-Associated Diarrhea: Evaluate if diarrhea occurs. (5.5)
•
Potential interactions producing elevation of blood pressure: monitor blood pressure. (5.6)
•
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (5.9)
•
Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): Monitor serum sodium levels regularly in patients at risk of hyponatremia and/or SIADH. (5.10)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, 5.3, 5.6, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.

LINEZOLID injection, for intravenous use

Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

9/2023

INDICATIONS AND USAGE

Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4)

Limitations of Use: (1.5)

•
Linezolid is not indicated for the treatment of Gram-negative infections.
•
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration
InfectionPediatric Patients
(Birth through 11 Years of Age)		Adults and Adolescents (12 Years and Older)Duration (days)

Nosocomial pneumonia (1.1)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

10 to 14

Community-acquired pneumonia, including concurrent bacteremia (1.2)

Complicated skin and skin structure infections (1.3)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (1.4)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

14 to 28

•
Pediatric Patients-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. (2.1)

DOSAGE FORMS AND STRENGTHS

Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to linezolid or any of the other product components. (4.1)
•
Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)

WARNINGS AND PRECAUTIONS

•
Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. (5.1)
•
Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. (5.2)
•
Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (5.3)
•
A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (5.4)
•
Clostridioides difficile-Associated Diarrhea: Evaluate if diarrhea occurs. (5.5)
•
Potential interactions producing elevation of blood pressure: monitor blood pressure. (5.6)
•
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (5.9)
•
Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): Monitor serum sodium levels regularly in patients at risk of hyponatremia and/or SIADH. (5.10)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, 5.3, 5.6, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023
Prescribing Information
Download Prescribing Information

Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.

LINEZOLID injection, for intravenous use

Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

9/2023

INDICATIONS AND USAGE

Linezolid is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia (1.1); Community-acquired pneumonia (1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.3); Vancomycin-resistant Enterococcus faecium infections. (1.4)

Limitations of Use: (1.5)

•
Linezolid is not indicated for the treatment of Gram-negative infections.
•
The safety and efficacy of Linezolid formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.6)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration
InfectionPediatric Patients
(Birth through 11 Years of Age)		Adults and Adolescents (12 Years and Older)Duration (days)

Nosocomial pneumonia (1.1)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

10 to 14

Community-acquired pneumonia, including concurrent bacteremia (1.2)

Complicated skin and skin structure infections (1.3)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (1.4)

10 mg/kg intravenously every 8 hours

600 mg intravenously every 12 hours

14 to 28

•
Pediatric Patients-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. (2.1)

DOSAGE FORMS AND STRENGTHS

Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)

CONTRAINDICATIONS

•
Known hypersensitivity to linezolid or any of the other product components. (4.1)
•
Patients taking any monoamine oxidase inhibitors (MAOI) or within two weeks of taking an MAOI. (4.2)

WARNINGS AND PRECAUTIONS

•
Myelosuppression: Monitor complete blood counts weekly. Thrombocytopenia has been reported more often in patients with severe renal and in patients with moderate to severe hepatic impairment. Consider discontinuation in patients who develop or have worsening myelosuppression. (5.1)
•
Peripheral and Optic Neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended. (5.2)
•
Serotonin Syndrome: Monitor patients taking serotonergic agents, including antidepressants and opioids, for signs of serotonin syndrome. Patients taking serotonergic antidepressants should receive linezolid only if no other therapies are available. Discontinue serotonergic antidepressants and monitor patients for signs and symptoms of both serotonin syndrome and antidepressant discontinuation. (5.3)
•
A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. (5.4)
•
Clostridioides difficile-Associated Diarrhea: Evaluate if diarrhea occurs. (5.5)
•
Potential interactions producing elevation of blood pressure: monitor blood pressure. (5.6)
•
Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. (5.9)
•
Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH): Monitor serum sodium levels regularly in patients at risk of hyponatremia and/or SIADH. (5.10)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Monoamine oxidase inhibitors and potential for interaction with adrenergic and serotonergic agents. (4.2, 5.3, 5.6, 7, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

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