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SANDOZ LINEZOLID is a brand name for Linezolid, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Linezolid (linezolid) 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: Sandoz Linezolid is not indicated for the treatment of Gram-negative infections. It is critical that specific…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Prior to instituting treatment with Sandoz Linezolid, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to Sandoz Sandoz Linezolid Page 6 of 46 Linezolid.
In infections where concomitant Gram-negative and/or anaerobic pathogens are suspected or are known to be present, Sandoz Linezolid must be used in combination with an appropriate antibiotic in order to provide adequate antimicrobial coverage.
If clinically indicated, treatment with Sandoz Linezolid 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 Sandoz Linezolid in an outpatient setting.
There is an increased risk of thrombocytopenia in patients with hepatic and renal impairment. The benefits of using Sandoz Linezolid 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 Sandoz Linezolid tablets for the treatment of infections in adults is described in Table 1. Doses of Sandoz Linezolid are administered every 12 hours (q12h). Table 1.
Dosage Guidelines for Sandoz Linezolid Infection* Dosage and Route of Administration Recommended Duration of Treatment (consecutive days) Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 600 mg oral q12h 14 to 28 Nosocomial pneumonia 600 mg oral q12h 10 to 14 Complicated skin and skin structure infections: a) Except diabetic foot infections 600 mg oral q12h 10 to 14 b) Non-limb threatening diabetic foot infections, without concomitant osteomyelitis 600 mg oral q12h 14 to 28 Community-acquired pneumonia, including concurrent bacteremia 600 mg oral q12h 10 to 14 Note: Patients with infection due to MRSA should be treated with Sandoz Linezolid 600 mg q12h Sandoz Linezolid Page 7 of 46 * 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:
Sandoz Linezolid 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:
Linezolid has not been studied in the treatment of necrotizing fasciitis or decubitus ulcers. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sandoz Linezolid and other antibacterial drugs, Sandoz 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.
1 Pediatrics • Pediatrics (< 18 years old): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics • Geriatrics: Although special monitoring is recommended, no overall differences in safety or effectiveness were observed between these patients and younger patients.
Sandoz Linezolid (linezolid) tablets 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. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). 4 Drug-Drug Interactions).
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 linezolid injection may be switched to Sandoz Linezolid tablets or linezolid oral suspension at the discretion of the physician, when clinically indicated. Sandoz Linezolid tablets may be taken with or without food.
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.
2 CONTRAINDICATIONS Sandoz Linezolid (linezolid) tablets 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. 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). 4 Drug-Drug Interactions). 1 Dosing Considerations Prior to instituting treatment with Sandoz Linezolid, appropriate specimens should be obtained for isolation of the causative organism(s) and for determination of susceptibility to Sandoz Sandoz Linezolid Page 6 of 46 Linezolid.
In infections where concomitant Gram-negative and/or anaerobic pathogens are suspected or are known to be present, Sandoz Linezolid must be used in combination with an appropriate antibiotic in order to provide adequate antimicrobial coverage.
If clinically indicated, treatment with Sandoz Linezolid 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 Sandoz Linezolid in an outpatient setting.
There is an increased risk of thrombocytopenia in patients with hepatic and renal impairment. The benefits of using Sandoz Linezolid 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 Sandoz Linezolid tablets for the treatment of infections in adults is described in Table 1. Doses of Sandoz Linezolid are administered every 12 hours (q12h). Table 1.
Dosage Guidelines for Sandoz Linezolid Infection* Dosage and Route of Administration Recommended Duration of Treatment (consecutive days) Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia 600 mg oral q12h 14 to 28 Nosocomial pneumonia 600 mg oral q12h 10 to 14 Complicated skin and skin structure infections: a) Except diabetic foot infections 600 mg oral q12h 10 to 14 b) Non-limb threatening diabetic foot infections, without concomitant osteomyelitis 600 mg oral q12h 14 to 28 Community-acquired pneumonia, including concurrent bacteremia 600 mg oral q12h 10 to 14 Note: Patients with infection due to MRSA should be treated with Sandoz Linezolid 600 mg q12h Sandoz Linezolid Page 7 of 46 * due to the designated pathogens (see 1 INDICATIONS) In controlled clinical trials, the protocol-defined duration of treatment for all infections […]