LINEZOLID KABI SOLUTION FOR INFUSION 2MG/ML [SIN15849P]

Product Info

LINEZOLID KABI SOLUTION FOR INFUSION 2MG/ML

[SIN15849P]

Indication

f) Indication

Nosocomial pneumonia
Community acquired pneumonia

Linezolid Kabi is indicated in adults for the treatment of the following infections caused by the susceptible strains of the designated Gram-positive bacteria only.
Community acquired pneumonia caused by Streptococcus pneumoniae (penicillin-sensitive strain only), including cases with concurrent bacteraemia, or Staphylococcus aureus (methicillin-sensitive strain only).
Nosocomial pneumonia caused by Staphylococcus aureus (methicillinsensitive and methicillin-resistant strains) or Streptococcus pneumoniae (penicillin-sensitive strains only).

Complicated skin and soft tissue infections caused by Staphylococcus aureus (methicillin-sensitive and methicillin resistant strains), Streptococcus pyogenes or Streptococcus agalactiae (see section j)Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Linezolid Kabi is indicated in adults for the treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria.

Linezolid should not be initiated as a first line therapy for community acquired pneumonia or uncomplicated skin infection, but may be considered if resistant strains are suspected or proven or in presence of drug allergy.
Linezolid is not active against infections caused by Gram negative pathogens.
Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected.
In determining whether Linezolid Kabi, is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Gram positive bacteria should be taken into consideration. (See section d) for the appropriate organisms – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist such as a microbiologist or infectious diseases specialist.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosing

g) Recommended Dosage

Posology:
Linezolid Kabi, 2 mg/ ml solution for infusion may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to either oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as linezolid has an oral bioavailability of approximately 100%.
Recommended dosage and duration of treatment for adults: The duration of treatment is dependent on the pathogen, the site of infection and its severity, and on the patient’s clinical response.
The following recommendations for duration of therapy reflect those used in the clinical trials. Shorter treatment regimens may be suitable for some types of infection but have not been evaluated in clinical trials.
The maximum treatment duration is 28 days. The safety and effectiveness of linezolid when administered for periods longer than 28 days have not been established. (see section j)Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
No increase in the recommended dosage or duration of treatment is required for infections associated with concurrent bacteraemia.
The dose recommendation for the solution for infusion are as follows:

Elderly patients: No dose adjustment is required.
Patients with renal insufficiency: No dose adjustment is required (see section j) Warnings and Precautions and d) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Patients with severe renal insufficiency (i.e. CL_CR < 30 ml/min): No dose adjustment is required. Due to the unknown clinical significance of higher exposure (up to 10 fold) to the two primary metabolites of linezolid in patients with severe renal insufficiency, linezolid should be used with special caution in these patients and only when the anticipated benefit is considered to outweigh the theoretical risk.
As approximately 30% of a linezolid dose is removed during 3 hours of haemodialysis, linezolid should be given after dialysis in patients receiving such treatment. The primary metabolites of linezolid are removed to some extent by haemodialysis, but the concentrations of these metabolites are still very considerably higher following dialysis than those observed in patients with normal renal function or mild to moderate renal insufficiency.
Therefore, linezolid should be used with special caution in patients with severe renal insufficiency who are undergoing dialysis and only when the anticipated benefit is considered to outweigh the theoretical risk.
To date, there is no experience of linezolid administration to patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or alternative treatments for renal failure (other than haemodialysis).

Patients with hepatic insufficiency: No dose adjustment is required. However, there are limited clinical data and it is recommended that linezolid should be used in such patients only when the anticipated benefit is considered to outweigh the theoretical risk (see section j) Warnings and Precautions and d) Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

i) Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section c) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

Linezolid should not be used in patients taking meperidine and any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid, selegiline, moclobemide) or within two weeks of taking any such medicinal product.
Unless there are facilities available for close observation and monitoring of blood pressure, linezolid should not be administered to patients with the following underlying clinical conditions or on the following types of concomitant medications:

• Patients with uncontrolled hypertension, phaeochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute confusional states.

• Patients taking any of the following medications: serotonin re-uptake inhibitors (see section j) Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), directly and indirectly acting sympathomimetic agents (including the adrenergic bronchodilators, pseudoephedrine and phenylpropanolamine), vasopressive agents (e.g. epinephrine, norepinephrine), dopaminergic agents (e.g. dopamine, dobutamine), pethidine or buspirone.

Animal data suggest that linezolid and its metabolites may pass into breast milk and, accordingly, breastfeeding should be discontinued prior to and throughout administration (see section l – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).