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ZYVOXAM is a brand name for Linezolid, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ZYVOXAM (linezolid injection and powder for oral suspension) is indicated for: Treatment of adult patients with the following infections, when caused by susceptible strains of the designated aerobic Gram-positive micro-organisms: Note: ZYVOXAM is not indicated for the treatment of Gram-negative infections. It is…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing considerations Prior to instituting treatment with ZYVOXAM, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to ZYVOXAM. In infections where concomitant Gram-negative and/or anaerobic pathogens are suspected or are known to be present, ZYVOXAM must be used in combination with an appropriate antibiotic in order to provide adequate antimicrobial coverage.
If clinically indicated, treatment with ZYVOXAM may be started empirically before results of susceptibility testing are available. Once culture results become available antimicrobial therapy can be adjusted accordingly. Because the inappropriate use of antibiotics can increase organism resistance, prescribers should carefully consider alternatives before initiating treatment with ZYVOXAM in an outpatient setting.
There is an increased risk of thrombocytopenia in patients with hepatic and renal impairment. The benefits of using ZYVOXAM in patients with hepatic and renal insufficiency should be weighed against the potential risks of thrombocytopenia (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Myelosuppression).
2 Recommended Dose and Dosage Adjustment The recommended dosage for ZYVOXAM (linezolid) Injection and Oral Suspension for the treatment of infections in adults is described in Table 1. Doses of ZYVOXAM are administered every 12 hours (q12h).
Table 1. Dosage Guidelines for ZYVOXAM Infection* Dosage and Route of Administration Recommended Duration of Treatment (consecutive days) Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 600 mg IV or oral q12h 14 to 28 Nosocomial pneumonia 600 mg IV or oral q12h 10 to 14 Complicated skin and skin structure infections: a) Except diabetic foot infections b) Non-limb threatening diabetic foot infections, without concomitant osteomyelitis 600 mg IV or oral q12h 600 mg IV or oral q12h 10 to 14 14 to 28 Community-acquired pneumonia, including 600 mg IV or oral q12h 10 to 14 PrZYVOXAM® (linezolid) Page 7 of 51 concurrent bacteremia Uncomplicated skin and skin structure infections 400 mg oral q12h 10 to 14 Note: Patients with infection due to MRSA should be treated with ZYVOXAM 600 mg q12h * due to the designated pathogens (see 1 INDICATIONS) In controlled clinical trials, the protocol-defined duration of treatment for all infections ranged from 7 to 28 days.
).
Vancomycin-Resistant Enterococcus faecium (VREF) Infections:
ZYVOXAM is indicated for the treatment of the following infections when due to VREF: • Intra-abdominal, skin and skin-structure, and urinary tract infections (including cases associated with concurrent bacteremia) (see 14 CLINICAL TRIALS).
Note:
This indication for VREF is based on non-comparative studies. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible strains only) including cases with concurrent bacteremia or Staphylococcus aureus (methicillin-susceptible and -resistant strains).
Complicated skin and skin structure infections, including non-limb threatening diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin- susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae.
Note:
ZYVOXAM has not been studied in the treatment of necrotizing fasciitis or decubitus ulcers. Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOXAM and other antibacterial drugs, ZYVOXAM 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.
ZYVOXAM (linezolid) Injection and Oral Suspension are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
g. phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. , dopamine, dobutamine). 4 Drug-Drug Interactions). PrZYVOXAM® (linezolid) Page 6 of 51
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Total treatment duration was determined by the treating physician based on site and severity of the infection, and on the patient’s clinical response. No dose adjustment is necessary when switching from intravenous to oral administration.
Patients whose therapy is started with ZYVOXAM Injection may be switched to ZYVOXAM Oral Suspension at the discretion of the physician, when clinically indicated. ZYVOXAM may be taken with or without food. 3 Reconstitution Oral Solutions: ZYVOXAM Powder for Suspension • Gently tap bottle to loosen powder.
Add a total of 123 mL distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After reconstitution, each 5 mL of the suspension contains 100 mg of linezolid (3 g/bottle).
Before using, gently mix by inverting the bottle 3 to 5 times. DO NOT SHAKE. Store reconstituted suspension at room temperature (15 - 30°C). Use within 21 days after reconstitution.
Parenteral Products:
ZYVOXAM Injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. As with all parenteral drug products, intravenous solutions should be inspected visually for clarity, particulate matter, precipitate and leakage prior to administration, whenever solution and container permit.
Solutions showing haziness, particulate matter, precipitate or leakage should not be used. ZYVOXAM Injection may exhibit a yellow color that can intensify over time without adversely affecting potency. Discard unused portions. 9% Sodium Chloride Injection, USP Lactated Ringer’s Injection, USP Compatibility: Physical incompatibilities resulted when ZYVOXAM Injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isethionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim- PrZYVOXAM® (linezolid) Page 8 of 51 sulfamethoxazole.
Additionally, chemical incompatibility resulted when ZYVOXAM Injection was combined with ceftriaxone sodium. 4 Administration Oral ZYVOXAM Powder for Suspension, may be given with or without food without regard to meals. Intravenous ZYVOXAM 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 ZYVOXAM 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.
3 Reconstitution, Compatible Intravenous Solutions). 5 Missed Dose If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed.
Doses should not be doubled.
1 Pediatrics • Pediatrics (< 18 years old): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics). 2 CONTRAINDICATIONS ZYVOXAM (linezolid) Injection and Oral Suspension are contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product. , dopamine, dobutamine). 4 Drug-Drug Interactions). 1 Dosing considerations Prior to instituting treatment with ZYVOXAM, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to ZYVOXAM.
In infections where concomitant Gram-negative and/or anaerobic pathogens are suspected or are known to be present, ZYVOXAM must be used in combination with an appropriate antibiotic in order to provide adequate antimicrobial coverage.
If clinically indicated, treatment with ZYVOXAM may be started empirically before results of susceptibility testing are available. Once culture results become available antimicrobial therapy can be adjusted accordingly. Because the inappropriate use of antibiotics can increase organism resistance, prescribers should carefully consider alternatives before initiating treatment with ZYVOXAM in an outpatient setting.
There is an increased risk of thrombocytopenia in patients with hepatic and renal impairment. The benefits of using ZYVOXAM in patients with hepatic and renal insufficiency should be weighed against the potential risks of thrombocytopenia (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Myelosuppression).
2 Recommended Dose and Dosage Adjustment The recommended dosage for ZYVOXAM (linezolid) Injection and Oral Suspension for the treatment of infections in adults is described in Table 1. Doses of ZYVOXAM are administered every 12 hours (q12h).
Table 1. Dosage Guidelines for ZYVOXAM Infection* Dosage and Route of Administration Recommended Duration of Treatment (consecutive days) Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 600 mg IV or oral q12h 14 to 28 Nosocomial pneumonia 600 mg IV or oral q12h 10 to 14 Complicated skin and skin structure infections: a) Except diabetic foot infections b) Non-limb threatening diabetic foot infections, without concomitant osteomyelitis 600 mg IV or oral q12h 600 mg IV or oral q12h 10 to 14 14 to 28 Community-acquired pneumonia, including 600 mg IV or oral q12h 10 to 14 PrZYVOXAM® (linezolid) Page 7 of 51 concurrent bacteremia Uncomplicated skin and skin structure infections 400 mg oral q12h 10 to 14 Note: Patients with […]