ZYVOX® Highlights

(linezolid)

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

ZYVOX (linezolid) injection, for intravenous use
ZYVOX (linezolid) tablets, for oral use
ZYVOX (linezolid) for oral suspension
Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

7/2023

INDICATIONS AND USAGE

ZYVOX 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); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5)


Limitations of Use (1.6):

ZYVOX is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of ZYVOX 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 ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.7)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration (2)

Infection (2)

Pediatric Patients
(Birth through 11 years of Age) (2)

Adults and Adolescents
(12 years and Older) (2)

Duration
(days) (2)

Nosocomial pneumonia (2)

10 mg/kg intravenous or oral every 8 hours (2)

600 mg intravenous or oral every 12 hours (2)

10 to 14 (2)

Community-acquired pneumonia, including concurrent bacteremia (2)

Complicated skin and skin structure infections (2)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (2)

10 mg/kg intravenous or oral every 8 hours (2)

600 mg intravenous or oral every 12 hours (2)

14 to 28 (2)

Uncomplicated skin and skin structure infections (2)

less than 5 yrs: 10 mg/kg oral every 8 hours
5–11 yrs: 10 mg/kg oral every 12 hours (2)

Adults: 400 mg oral every 12 hours
Adolescents: 600 mg oral every 12 hours (2)

10 to 14 (2)

DOSAGE FORMS AND STRENGTHS

Injection: 200 mg/100 mL (2 mg/mL) and 600 mg/300 mL (2 mg/mL) linezolid. (3)
Tablet: 600 mg linezolid. (3)
For oral suspension: 100 mg of linezolid per each 5 mL. (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 ZYVOX 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)
Phenylketonuria: ZYVOX for Oral Suspension contains phenylalanine which can be harmful to patients with phenylketonuria. (5.11)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and/or pediatric patients treated with ZYVOX) 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: 8/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

ZYVOX (linezolid) injection, for intravenous use
ZYVOX (linezolid) tablets, for oral use
ZYVOX (linezolid) for oral suspension
Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Myelosuppression (5.1)

7/2023

INDICATIONS AND USAGE

ZYVOX 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); Uncomplicated skin and skin structure infections (1.4); Vancomycin-resistant Enterococcus faecium infections. (1.5)


Limitations of Use (1.6):

ZYVOX is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of ZYVOX 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 ZYVOX formulations and other antibacterial drugs, ZYVOX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.7)

DOSAGE AND ADMINISTRATION

Dosage, Route, and Frequency of Administration (2)

Infection (2)

Pediatric Patients
(Birth through 11 years of Age) (2)

Adults and Adolescents
(12 years and Older) (2)

Duration
(days) (2)

Nosocomial pneumonia (2)

10 mg/kg intravenous or oral every 8 hours (2)

600 mg intravenous or oral every 12 hours (2)

10 to 14 (2)

Community-acquired pneumonia, including concurrent bacteremia (2)

Complicated skin and skin structure infections (2)

Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia (2)

10 mg/kg intravenous or oral every 8 hours (2)

600 mg intravenous or oral every 12 hours (2)

14 to 28 (2)

Uncomplicated skin and skin structure infections (2)

less than 5 yrs: 10 mg/kg oral every 8 hours
5–11 yrs: 10 mg/kg oral every 12 hours (2)

Adults: 400 mg oral every 12 hours
Adolescents: 600 mg oral every 12 hours (2)

10 to 14 (2)

DOSAGE FORMS AND STRENGTHS

Injection: 200 mg/100 mL (2 mg/mL) and 600 mg/300 mL (2 mg/mL) linezolid. (3)
Tablet: 600 mg linezolid. (3)
For oral suspension: 100 mg of linezolid per each 5 mL. (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 ZYVOX 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)
Phenylketonuria: ZYVOX for Oral Suspension contains phenylalanine which can be harmful to patients with phenylketonuria. (5.11)

ADVERSE REACTIONS

Most common adverse reactions (>5% of adult and/or pediatric patients treated with ZYVOX) 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: 8/2023

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