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LINEZOLID INJECTION, for intravenous use
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
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 (1.1); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis (1.2); Vancomycin-resistant Enterococcus faecium infections (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of linezolid formulations 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 bacteria (1.4)
DOSAGE AND ADMINISTRATION
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Dosage, Route, and Frequency of Administration (2.1)
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Infection
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Pediatric
Patients
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Adults and
Adolescents
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Duration
(days)
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Nosocomial pneumonia
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10 mg/kg intravenous every 8 hours
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600 mg intravenous every 12 hours
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10 to 14
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Community-acquired pneumonia, including concurrent bacteremia
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Complicated skin and skin structure infections
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Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia
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10 mg/kg intravenous every 8 hours
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600 mg intravenous every 12 hours
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14 to 28
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DOSAGE FORMS AND STRENGTHS
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Injection: 600 mg linezolid ( 3)
CONTRAINDICATIONS
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Known hypersensitivity to linezolid or any of the other product components. ( 4.1) Patients taking any monoamine oxidase inhibitor (MAOI) or within two weeks of taking an MAOI. ( 4.2)
WARNINGS AND PRECAUTIONS
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Myelosuppression: Monitor complete blood counts weekly. Consider discontinuation in patients who develop or have worsening myelosuppression. ( 5.1)
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Peripheral and optic neuropathy: Reported primarily in patients treated for longer than 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic eva luation is recommended. ( 5.2)
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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)
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A mortality imbalance was seen in an investigational study in linezolid-treated patients with catheter-related bloodstream infections. ( 5.4)
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Clostridium difficile associated diarrhea: eva luate if diarrhea occurs. ( 5.5)
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Potential interactions producing elevation of blood pressure: monitor blood pressure ( 5.6)
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Hypoglycemia: Postmarketing cases of symptomatic hypoglycemia have been reported in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents. ( 5.9)
ADVERSE REACTIONS
Most common adverse reactions (> 5% of adult and/or pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, 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: 6/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
Linezolid is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. 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)].
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. Linezolid has not been studied in the treatment of decubitus ulcers [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 linezolid and other antibacterial drugs, linezolid 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 linezolid formulations given for longer than 28 days have not been eva luated in controlled clinical trials.
2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
The recommended dosage for linezolid formulations for the treatment of infections is described in Table 1.
No dose adjustment is necessary when switching from intravenous to oral administration.
2.2 Intravenous Administration
Linezolid Injection is supplied in single-use, ready-to-use container (VisIV™ Container). 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.
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.
3 DOSAGE FORMS AND STRENGTHS
Linezolid Injection: 300 mL (600 mg linezolid) single-use, ready-to-use flexible plastic VisIVTM containers in a foil laminate overwrap.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Linezolid Injection is contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.
4.2 Monoamine Oxidase Inhibitors
Linezolid should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g., phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product.
5 WARNINGS AND PRECAUTIONS
5.1 Myelosuppression
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with pre-existing myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with a chronic infection who have received previous or concomitant antibacterial therapy. Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression.
5.2 Peripheral and Optic Neuropathy
Peripheral and optic neuropathies have been reported in patients treated with linezolid, primarily in those patients treated for longer than the maximum recommended duration of 28 days. In cases of optic neuropathy that progressed to loss of vision, patients were treated for extended periods beyond the maximum recommended duration. Visual blurring has been reported in some patients treated with linezolid for less than 28 days. Peripheral and optic neuropathy has also been reported in children.
If patients experi |
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